NIH_SPENDING_CATS: Cancer

PHR: Project Narrative  Not applicable. This document is attached to satisfy electronic submission requirements.

PI_NAMEs: ROGERS, JENNIFER F (contact)

PROJECT_TERMS: Administrative Efficiency;anti-cancer research;Area;Automobile Driving;Award;Businesses;Cancer Center;Cancer Center Support Grant;cancer research center director;Characteristics;Clinical Cancer Center;Clinical Data;Clinical Protocols;Clinical Research;Clinical Treatment;Clinical Trials;Collaborations;Communication;Community Health Education;Community Outreach;Competence;Comprehensive Cancer Center;Contracts;Coupled;Data;data management;Decision Making;diversity and inclusion;Education;Electronics;Ensure;equity, diversity, and inclusion;Evaluation;experience;Faculty;falls;Fostering;Funding;Future;Goals;Grant;Growth;Healthcare;improved;Infrastructure;innovation;Intervention;Investments;Kentucky;Lead;Leadership;Malignant Neoplasms;meetings;member;Mentors;Mission;Monitor;Multi-Institutional Clinical Trial;NCI Center for Cancer Research;Organization and Administration;Output;outreach;Patients;Peer Review;Play;Policies;Process;programs;recruit;Reporting;Research;Research Activity;Research Personnel;Resource Sharing;Resources;Role;Science;Site;square foot;Strategic Planning;Structure;success;System;Technology;Training and Education;treatment trial;Universities;Vision;web site;Work

PROJECT_TITLE: Cancer Center Administration


ADMINISTERING_IC: CA

ARRA_FUNDED: N

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: MEMPHIS

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: ST. JUDE CHILDREN'S RESEARCH HOSPITAL

ORG_STATE: TN

PHR: Narrative Evasion of core cell death pathways is a “hallmark” of cancer. The PI has consistently made highly impactful contributions to our understanding of the fundamental mechanisms of regulated cell death, especially in the areas of apoptosis and necroptosis. The project described in this application will significantly extend this understanding, and how it relates to cancer.

PI_NAMEs: GREEN, DOUGLAS R. (contact)

PROGRAM_OFFICER_NAME: SALNIKOW, KONSTANTIN

PROJECT_TERMS: Apoptosis;Apoptotic;Area;Arithmetic;BCL2 gene;Caspase;Cell Death;Cell Physiology;Cell Survival;Cells;Cessation of life;Childhood;Databases;Equation;Family;Future;Genome;Goals;Laboratories;Life;Malignant Neoplasms;Mitochondria;Molecular;Necrosis;Pathology;Pathway interactions;Patient-Focused Outcomes;Permeability;Process;programs;Proteins;Regulation;Research;Resistance;Saint Jude Children's Research Hospital;Stimulus;success;Testing;The Cancer Genome Atlas;Therapeutic;Tissues;tool;Work;Xenograft Model

PROJECT_TITLE: Mechanisms of Regulated Cell Death


ADMINISTERING_IC: GM

ED_INST_TYPE: SCH ALLIED HEALTH PROFESSIONS

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Pediatric;Rural Health;Social Determinants of Health

ORG_CITY: KNOXVILLE

ORG_DEPT: PSYCHOLOGY

ORG_NAME: UNIVERSITY OF TENNESSEE KNOXVILLE

PHR: Project Narrative Rural Appalachia faces significant health disparities compared to the rest of the country, linked to high rates of poverty, which are, in turn linked to low rates of educational attainment and diminished job opportunities. Imagining Possibilities aims to increase the number of rural Appalachian high school students choosing to pursue post-secondary education and enter a STEMM (science, technology, engineering, math, medical) field. Achieving this goal will help diversify the biomedical workforce and positively address healthcare disparities in rural Appalachia.

PI_NAMEs: GIBBONS, MELINDA MILLER (contact);HARDIN, ERIN E.

PROGRAM_OFFICER_NAME: FAUPEL-BADGER, JESSICA

PROJECT_TERMS: Address;Adult;Appalachian Region;Area;Bachelor's Degree;Behavioral Research;Belief;Biomedical Research;career;career preparation;Clinical Research;Cognitive;college;Communities;comparison group;Complex;Country;County;Coupled;Data;design;Disease;Education;Educational process of instructing;efficacious intervention;Engineering;Enrollment;Equilibrium;Evaluation;Exhibits;expectation;experience;Face;Failure;Foundational Skills;Future;Goals;graduate school;Growth;health care availability;health care disparity;health disparity;high school;High School Student;higher education;Hylobates Genus;Incidence;Industry;innovation;interest;Intervention;Intervention Studies;Learning;life span;Link;Low income;Mathematics;Medical;Medically Underserved Area;Minority;multi-component intervention;Nature;novel;Occupations;Outcome;Persons;Population;Poverty;programs;Public Health;Public Health Education;recruit;Research;Research Personnel;Rest;Rural;Rural Appalachia;rural area;Schools;Science;Scientist;Secondary Schools;Self Efficacy;Services;skills;social;Students;success;Technology;Tennessee;theories;tool;Trust;undergraduate student;Work;Youth

PROJECT_TITLE: Imagining Possibilities in Post-Secondary education and STEMM in Rural Appalachia

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-CB-J(57)R]


ADMINISTERING_IC: EB

ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Assistive Technology;Behavioral and Social Science;Bioengineering;Caregiving Research;Clinical Research;Disability Research;Health Services;Networking and Information Technology R&D (NITRD);Physical Rehabilitation;Rehabilitation

ORG_CITY: SEATTLE

ORG_DEPT: BIOSTATISTICS & OTHER MATH SCI

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: By enabling near term deployments of assistive robots in the home, this project will directly impact millions  of people in the U.S. and worldwide living with a motor limitation and associated independent living  disabilities. It can also allow our aging population to live in place longer, enable remote caregiving, and  reduce caregiving costs.

PI_NAMEs: CAKMAK, MAYA  (contact)

PROGRAM_OFFICER_NAME: BITTMANN, MORIA FISHER

PROJECT_TERMS: Activities of Daily Living;aging population;Algorithms;assistive robot;automated algorithm;Automation;Caregivers;caregiving;Computer software;cost;Development;disability;Ensure;Environment;Evaluation;Face;functional independence;Goals;Guidelines;Home;Home environment;Implant;Independent Living;instrument;light weight;Literature;Manuals;Maps;Measurement;Measures;Motor;Occupational Therapist;open source;operation;Output;Persons;Phase;preference;Research;Robot;robot assistance;robot control;Safety;Stretching;System;Systems Integration;teleoperation;usability;Variant;Work

PROJECT_TITLE: NRI: Adaptive Teleoperation Interfaces for In-Home Assistive Robots


ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: RESEARCH CENTERS

ORG_CITY: SAN FRANCISCO

ORG_DEPT: NEUROSURGERY

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

ORG_STATE: CA

PHR: Project Narrative Despite the best efforts of neurosurgeons and neuro-oncologists, the incidence and mortality rates of brain cancer have remained stable over the past 20 years. Unfortunately, in 2021 alone, more than 18,000 people died of brain and other CNS tumors. Through the work proposed in this SPORE application, we will develop noninvasive measures to improve our diagnosis and response-assessment and novel cellular immunotherapy to improve the lives of individuals with brain cancer.

PI_NAMEs: BERGER, MITCHEL S. (contact)

PROGRAM_OFFICER_NAME: HUBBARD, LEAH

PROJECT_TERMS: Acceleration;Achievement;Address;Adopted;Adoptive Transfer;Age;alpha ketoglutarate;Antigens;Autologous;Biological;Biological Markers;Biometry;Blood;blood-based biomarker;Brain;Brain Neoplasms;CAR T cell therapy;career;Cells;Cellular immunotherapy;Central Nervous System;Central Nervous System Neoplasms;chimeric antigen receptor;chimeric antigen receptor T cells;Clinic;Clinical;Comprehensive Cancer Center;Data;Death Rate;Development;Dexamethasone;Diagnosis;Diagnostic;DNA Methylation;early detection biomarkers;Early treatment;efficacy evaluation;Evaluation;exhaustion;Exhibits;Faculty;Family;first-in-human;Funding;Genes;Genetic Engineering;Glioblastoma;Glioma;Glutamates;Grant;Heart;Heterogeneity;Homing;Human;Image;imaging approach;imaging biomarker;imaging probe;Immune;immunoregulation;Immunotherapy;improved;Incidence;Individual;innovation;Intravenous infusion procedures;Isocitrate Dehydrogenase;Laboratory Finding;Magnetic Resonance Imaging;Malignant neoplasm of brain;Measures;member;Metabolic Marker;Methods;methylation biomarker;Modality;Modeling;mutant;Myeloid-derived suppressor cells;neuro-oncology;Neurosurgeon;non-invasive imaging;notch protein;novel;novel therapeutic intervention;Pathology;Patient Care;Patients;peripheral blood;Persons;phase 1 study;phase I trial;Phenotype;pre-clinical;Pre-Clinical Model;preclinical study;Production;prognostic model;prognostic tool;programs;prospective;Pyruvate;radiation response;radiological imaging;receptor;Research;Research Personnel;Research Project Grants;Resected;response;response biomarker;Role;Safety;Sampling;Scientist;Stratification;System;T cell therapy;T-Lymphocyte;Techniques;Testing;Therapeutic;Tissues;tool;Toxic effect;Translating;Translational Research;treatment response;tumor;Tumor Burden;Work;Xenograft procedure

PROJECT_TITLE: Brain Tumor SPORE Grant


NIH_SPENDING_CATS: Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Immunotherapy;Neurosciences;Rare Diseases

PROJECT_TERMS: Adoptive Transfer;Autologous;Award;Basic Science;Biological Markers;Brain Neoplasms;career;Clinical;Communication;Communities;Complex;cost;Decision Making;Development;Diagnosis;Doctor of Philosophy;Ensure;experience;Funding;Glioma;Grant;imaging modality;Immunotherapy;Individual;Institution;Manuscripts;meetings;mutant;non-invasive imaging;novel;operation;Patients;Play;Preparation;programs;Reporting;Research;Research Personnel;Research Project Grants;Role;Schedule;Science;Series;T-Lymphocyte;Time;Translational Research;treatment response;United States National Institutes of Health;Vision

PROJECT_TITLE: Administrative Core


NIH_SPENDING_CATS: Cancer;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Pediatric;Prevention;Rural Health;Social Determinants of Health

ORG_CITY: LEXINGTON

ORG_NAME: UNIVERSITY OF KENTUCKY

ORG_STATE: KY

PI_NAMEs: O'CONNOR, KATHLEEN L. (contact)

PROJECT_TERMS: Academic Training;Address;American Cancer Society;anti-cancer research;Award;base;Basic Science;Cancer Burden;cancer care;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer education;cancer prevention;career;Career Choice;career development;Catchment Area;cellular oncology;Centers of Research Excellence;Clinic;Clinical;Clinical Investigator;clinical practice;Clinical Research;Clinical Trials;community engagement;Community Outreach;Complement;Dedications;design;Development;diversity and inclusion;Education;Education Projects;education research;Educational Activities;educational atmosphere;Educational Curriculum;Educational Status;Electronics;Evolution;Extramural Activities;Faculty;Fostering;Foundations;Funding;Goals;Grant;Growth;health equity;Health Professional;health training;high school;High School Student;improved;Individual;innovation;Institution;interest;investigator-initiated trial;Investments;Kentucky;Link;Malignant Neoplasms;Medical;Medical Residency;meetings;Mentors;Mentorship;Middle School Student;Mission;Modernization;molecular oncology;NCI Center for Cancer Research;next generation;Oncology;Physicians;Population;Population Research;Postdoctoral Fellow;Prevention;programs;Research;research faculty;Research Personnel;Research Project Grants;Research Training;Resources;Rural Appalachia;Rural Population;rural underserved;Science;Scientist;Structure;symposium;Time;Training;Training and Education;training data;training opportunity;Training Programs;Translating;translational oncology;Translational Research;undergraduate research experience;undergraduate student;Underrepresented Minority;Underrepresented Populations;Underserved Population;United States National Institutes of Health;Universities;Urban Population;Vulnerable Populations;Youth

PROJECT_TITLE: Cancer Research Training and Education Coordination


ADMINISTERING_IC: HL

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Prevention;Racial and Ethnic Minority Health Research;Sleep Research;Social Determinants of Health

ORG_CITY: NEW YORK

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

ORG_STATE: NY

PHR: PROJECT NARRATIVE Using a syndemic and multi-level approach, this project seeks to investigate relationships between sleep and HIV treatment outcomes and behaviors (e.g., viral suppression and retention in care) among Black gay, bisexual and other sexual minority men (SMM), a population in the United States heavily impacted by HIV/AIDS.

PI_NAMEs: DUNCAN, DUSTIN T (contact);SCHNEIDER, JOHN

PROGRAM_OFFICER_NAME: DIXIT, SHILPY

PROJECT_TERMS: actigraphy;Address;Adherence;Affect;antiretroviral therapy;Behavior;Bisexual;Black Populations;Black race;Body mass index;care outcomes;Caring;Chicago;Clinical;cohort;Cohort Studies;community violence;comorbidity;Complex;contextual factors;Continuity of Patient Care;Counseling;Data;Decision Making;Dedications;Disparity;Eligibility Determination;Enrollment;Epidemic;Epidemiology;experience;follow-up;Funding;Gays;General Population;health care service;health determinants;health inequalities;Health Services;HIV;HIV Infections;HIV Seropositivity;HIV/AIDS;Housing;improved;Incidence;Individual;Injectable;innovation;Intervention;intimate partner violence;Link;Longitudinal Studies;marginalization;marginalized population;Measures;medication compliance;Mental Health;Methodology;multidisciplinary;Neighborhoods;next generation;novel strategies;nutrition;Obesity;Outcome;Participant;Patient Self-Report;Persons;Polysomnography;poor sleep;Population;Prevention;primary outcome;Prospective, cohort study;Protocols documentation;racial minority population;Research;Sampling;secondary outcome;sexual minority group;sexual minority men;skills;Sleep;Sleep Disorders;sleep health;sleep quality;Social Environment;social epidemiology;Social Network;social stigma;substance use;substance use treatment;success;syndemic;therapy adherence;Time;trait;Translations;transmission process;treatment adherence;Treatment outcome;United States;United States National Institutes of Health;Viral;Viral Load result;Visit;willingness;Wrist

PROJECT_TITLE: Characterizing Sleep, ART Adherence and Viral Suppression Among Black Sexual Minority Men


NIH_SPENDING_CATS: Brain Cancer;Brain Disorders;Cancer;Cancer Genomics;Clinical Research;Clinical Trials and Supportive Activities;Genetics;Human Genome;Immunotherapy;Neurosciences;Orphan Drug;Precision Medicine;Prevention;Rare Diseases

PHR: Project Narrative Primary brain cancers kill about 13,000 Americans a year and rank first among all cancer sites for average years of life lost. This project will use cutting-edge epigenomic science to develop and validate a new generation of immune biomarkers to improve glioma survival prognostication and will provide clinically applicable tools to identify tumor IDH status prior to surgical intervention and evaluate the effects of radiation and immunotherapy. Enhanced understanding of these factors may provide targets for future interventions.

PI_NAMEs: MOLINARO, ANNETTE M (contact)

PROJECT_TERMS: Address;Adoptive Cell Transfers;Adrenal Cortex Hormones;Age;Algorithms;American;anti-PD-1;Astrocytoma;B-Lymphocytes;Bioinformatics;Biological Markers;Blood;blood-based biomarker;Brain Neoplasms;cancer site;CD8-Positive T-Lymphocytes;Cells;Clinical;clinical application;Clinical Data;Clinical Trials;Clinical Trials Design;clinically relevant;Data;Dexamethasone;Diagnosis;DNA Methylation;DNA Modification Methylases;Enhancing Lesion;epigenomics;Exhibits;Freezing;Future;Generations;Genome;Genomics;Glioblastoma;Glioma;Grant;Heterogeneity;Immune;Immune system;Immunologic Factors;Immunologic Markers;Immunosuppression;Immunotherapy;improved;indexing;Individual;innovation;Intervention;Isocitrate Dehydrogenase;Lesion;Libraries;Magnetic Resonance Imaging;Malignant neoplasm of brain;Measures;Memory;Methodology;Methods;Methylation;methylation pattern;Modality;Modeling;Molecular;monocyte;Mutation;Myeloid-derived suppressor cells;Natural Killer Cells;Neoadjuvant Therapy;neutrophil;novel;oligodendroglioma;Operative Surgical Procedures;Other Genetics;Outcome;Patient Recruitments;Patients;Pattern;PD-1/PD-L1;Peripheral;peripheral blood;Population;Predictive Factor;Prognosis;prognosis biomarker;Prognostic Factor;prognostic model;prognostication;Radiation;radiation effect;Radiology Specialty;Repeat Surgery;response;response biomarker;Risk;Science;Standardization;Steroids;Stratification;Subgroup;Techniques;Technology;Testing;Therapeutic;tool;translational goal;treatment response;tumor;Uncertainty;Whole Blood;years of life lost

PROJECT_TITLE: Project 1: DNA Methylation-Based Blood Biomarkers for Prognosis, Molecular Stratification and Treatment Response in Glioma Patients


ADMINISTERING_IC: HD

IC_NAME: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

NIH_SPENDING_CATS: Behavioral and Social Science;Chronic Pain;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Contraception/Reproduction;Fibromyalgia;Pain Research;Physical Activity;Precision Medicine;Prevention;Women's Health Research

ORG_CITY: ANN ARBOR

ORG_DEPT: OBSTETRICS & GYNECOLOGY

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

ORG_STATE: MI

PHR: PROJECT NARRATIVE: The proposed research is highly relevant to public health as chronic pelvic pain afflicts 15-20% of reproductive age women and is associated with decreased productivity, reduced quality of life, multiple surgeries with consequential fertility implications, and long-term medical therapies at a cost of at least $2.8 billion annually. Development of effective, personalized treatment options for chronic pelvic pain is critically important. There is increasing evidence supporting use of non-pharmacologic therapies in chronic pelvic pain and other conditions, but their use is frequently hampered by limited availability of providers, particularly in underserved areas, lack of insurance coverage, and out-of-pocket costs. Web-based delivery of these bundled non-pharmacologic therapies is ideal because it allows expanded access with essentially fixed costs. This research proposes to develop a web-based integrative self-management program for chronic pelvic pain utilizing cognitive/behavioral, acupressure, and physical activity modalities and evaluate program effectiveness and patient phenotypic factors associated with symptom improvement.

PI_NAMEs: TILL, SARA R (contact)

PROGRAM_OFFICER_NAME: AHN, HELENA HYESOOK

PROJECT_TERMS: Acupressure;Age;Behavioral;Central Nervous System;Characteristics;Chronic;chronic painful condition;chronic pelvic pain;Clinical;clinical development;clinical phenotype;Cognitive;Cognitive Therapy;comorbidity;Complex;cost;Data;demographics;Development;effective therapy;Effectiveness;Effectiveness of Interventions;efficacy trial;Ensure;Evaluation;exercise intervention;Fertility;Fibromyalgia;fibromyalgia patients;Focus Groups;Foundations;Goals;group intervention;Heterogeneity;Hysterectomy;improved;Individual;individual patient;Insurance Coverage;Intervention;Intervention Trial;Medical;Mentors;Modality;Modeling;Nonpharmacologic Therapy;online delivery;Online Systems;Operative Surgical Procedures;Pain;Pain interference;Pain management;pain patient;Pathology;Patient Outcomes Assessments;Patients;Peripheral;Peripheral Nervous System;personalized approach;personalized medicine;Pharmacological Treatment;Phenotype;Physical activity;Physical Function;Physical therapy;Pilot Projects;Population;Predictive Factor;Process;Productivity;Program Effectiveness;programs;Provider;psychologic;Public Health;Quality of life;Randomized;Randomized, Controlled Trials;reproductive;Research;Resolution;responders and non-responders;response;Self Management;self-management program;skills;symptomatic improvement;Tissues;tool;Training;treatment as usual;treatment strategy;underserved area;Uninsured Medical Expense;Woman

PROJECT_TITLE: An Intervention for Chronic Pelvic Pain

STUDY_SECTION: CHHD

STUDY_SECTION_NAME: Reproduction, Andrology, and Gynecology Study Section[CHHD-R]


NIH_SPENDING_CATS: Cancer;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Rural Health;Social Determinants of Health

PHR: Project Narrative Not applicable. This document is attached to satisfy electronic submission requirements.

PI_NAMEs: WILLIAMS, LOVORIA B (contact)

PROJECT_TERMS: Academy;Acceleration;Achievement;Address;anti-cancer research;Appalachian Region;Appointment;Area;Black race;Cancer Burden;Cancer Center;Cancer Center Support Grant;cancer health disparity;cancer research center director;career;Career Choice;career development;Career Mobility;Catchment Area;Climate;clinical center;clinical encounter;Clinical Sciences;community engagement;Community Outreach;Comprehensive Cancer Center;Data;Decision Making;Dedications;demographics;Development;Disparity;early-career faculty;Education;Education and Outreach;education research;Electronics;Environment;Equity;equity, diversity, and inclusion;experience;Faculty;Funding;Goals;Growth;health equity;high school;Hispanic Populations;improved;Infrastructure;Institution;Kentucky;Leadership;leadership development;lens;male;Malignant Neoplasms;member;Methods;Minority;Minority Access;minority trainee;Mission;Modeling;Monitor;multidisciplinary;NCI-Designated Cancer Center;Not Hispanic or Latino;Oncology;oncology program;Pathway interactions;Population;Prevention;Process;Program Development;programs;Racial Equity;Recommendation;recruit;Reporting;Research;research and development;Research Personnel;Research Priority;Resources;Role;Rural;Rural Appalachia;Scholars Program;Science;Strategic Planning;success;Talents;Textiles;Training;Training and Education;Translational Research;undergraduate student;Underrepresented Minority;United States National Institutes of Health;Universities;Vulnerable Populations;Woman;Workforce Development

PROJECT_TITLE: Plan to Enhance Diversity


ADMINISTERING_IC: AI

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Coronaviruses;Coronaviruses Therapeutics and Interventions;Emerging Infectious Diseases;Genetics;Infectious Diseases

ORG_CITY: STILLWATER

ORG_DEPT: CHEMISTRY

ORG_NAME: OKLAHOMA STATE UNIVERSITY STILLWATER

ORG_STATE: OK

PHR: Project Narrative This proposal seeks to characterize the structural mechanism by which SAS-CoV-2 nsp13 helicase translocates along viral RNA. We hypothesize that ATP hydrolysis couples to RNA translocation through an allosteric network. Our collaborative workflow is uniquely suited to test this hypothesis since we are able to examine the protein from the atomic to virus length-scale. The results from this study will aid in the development of antivirals and guide attenuated vaccine development.

PI_NAMEs: MCCULLAGH, MARTIN  (contact)

PROGRAM_OFFICER_NAME: PLIMACK, MARY KATHERINE BRADFORD

PROJECT_TERMS: 2019-nCoV;Address;analog;Anti-viral Agents;antiviral drug development;Arginine;ATP Hydrolysis;ATP phosphohydrolase;Attenuated Vaccines;Behavior;Binding;Biochemical;Biological Assay;Catalysis;Cessation of life;Characteristics;combat;Communication;Coupled;Couples;COVID-19;Crystallography;Data;Dengue;Development;Economics;Elements;Enzyme Kinetics;enzyme mechanism;enzyme structure;Enzymes;experience;experimental study;Goals;Health;helicase;holistic approach;Hydrolysis;improved;in silico;In Vitro;Individual;inhibitor;insight;Knowledge;Length;Life Cycle Stages;Ligand Binding;Ligands;Maps;Middle East Respiratory Syndrome;Modeling;Molecular;Molecular Conformation;molecular dynamics;molecular scale;Motion;multi-scale modeling;Mutagenesis;mutant;Mutation;Nonstructural Protein;novel;Nucleotides;Pathway Analysis;Personal Satisfaction;Persons;Phenotype;Play;Process;Proteins;Protocols documentation;Quantum Mechanics;rational design;Reaction;Research Personnel;Resistance;resistance mutation;resistant strain;response;RNA;RNA Binding;RNA Helicase;RNA Viruses;RNA-Protein Interaction;SARS coronavirus;simulation;Site-Directed Mutagenesis;skills;Structure;Structure-Activity Relationship;Subgroup;targeted treatment;Techniques;Temperature;Testing;therapeutic development;tripolyphosphate;vaccine development;Vaccines;Viral;Viral Proteins;viral RNA;Virus;Virus Replication;Work;X-Ray Crystallography

PROJECT_TITLE: Defining the Translocation Mechanisms of SARS-CoV-2 nsp13 Helicase to Aid in Antiviral Development

STUDY_SECTION: MSFD

STUDY_SECTION_NAME: Macromolecular Structure and Function D Study Section[MSFD]


NIH_SPENDING_CATS: Biomedical Imaging;Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Neurosciences;Orphan Drug;Precision Medicine;Rare Diseases

PHR: Project Narrative The discovery of isocitrate dehydrogenase (IDH) mutation has had a significant impact on the diagnosis and prognosis of adult infiltrative glioma and provides an opportunity for the development of novel treatments. The proposed study will utilize novel hyperpolarized probes, selected because of the specificity of IDHm tumor metabolism, to better delineate tumor burden and elucidate early biomarkers of treatment response. The translation of dynamic, non-invasive metabolic imaging biomarkers will enhance the evaluation of novel therapies and assist in the optimal management of IDHm patients.

PI_NAMEs: CHANG, SUSAN M (contact)

PROJECT_TERMS: activity marker;Adult;Adult Glioma;Aftercare;alpha ketoglutarate;anatomic imaging;Biological;Biological Markers;Biology;Biostatistics Core;Brain;Brain Neoplasms;Characteristics;Classification;Clinical;clinical implementation;Clinical Research;Clinical Trials;cohort;Collaborations;design;Development;Diagnosis;Diagnostic;drug development;early detection biomarkers;Early treatment;Edema;Evaluation;Excision;experience;Genetic Engineering;Glioblastoma;Glioma;Gliosis;Glutamates;Grant;Growth;high risk;Image;image guided;imaging approach;imaging biomarker;imaging capabilities;imaging probe;improved;industry partner;Infrastructure;innovation;International;Isocitrate Dehydrogenase;Leadership;Lesion;Location;Magnetic Resonance Imaging;Malignant - descriptor;Measures;Metabolic;metabolic imaging;Metabolic Marker;Metabolism;Modeling;Monitor;Multimodal Imaging;mutant;Mutation;Newly Diagnosed;non-invasive imaging;Normal tissue morphology;novel;novel therapeutic intervention;novel therapeutics;Operative Surgical Procedures;Pathologic;Pathology;Patient Schedules;Patients;Pharmaceutical Preparations;pharmacodynamic biomarker;Pharmacodynamics;Phase;Population;Positioning Attribute;pre-clinical;Production;Prognosis;Property;Pyruvate;Rattus;recruit;Recurrence;Reporting;Research Personnel;Resources;response;response biomarker;Scanning;Specificity;Surgical Management;Technology;Testing;therapeutic development;Time;Tissue Sample;Tissues;Translating;Translations;treatment response;tumor;Tumor Burden;tumor metabolism;volunteer

PROJECT_TITLE: Project 2: Novel hyperpolarized C-13 imaging as metabolic markers of response in IDH mutant glioma


NIH_SPENDING_CATS: Behavioral and Social Science;Cancer;Clinical Research;Dissemination and Implementation Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Effects of Indoor Air Pollution;Health Services;Lung;Lung Cancer;Prevention;Rural Health;Social Determinants of Health;Tobacco;Tobacco Smoke and Health

PI_NAMEs: KUHS, KRYSTLE A. (contact)

PROJECT_TERMS: Address;Adoption;Affect;Appalachian Region;Area;Award;Behavioral;Cancer Burden;cancer care;Cancer Center;Cancer Center Support Grant;Cancer Control;Cancer Control Research Program;cancer health disparity;cancer prevention;cancer risk;Cancer Survivor;Cancer Survivorship;carcinogenicity;Caring;Catchment Area;cellular oncology;Clinic;Clinical Trials;Collaborations;college;Communities;community collaboration;community engaged research;community engagement;Community Outreach;County;design;Disclosure;Dissemination and Implementation;Early Diagnosis;Education;efficacy testing;Electronics;Ensure;Environmental Exposure;ethnic minority population;Evidence based intervention;Financial Hardship;Fostering;Funding;Future;genetic association;genetic epidemiology;Genetic Markers;Goals;Grant;Growth;Health Policy;Healthcare;Hepatitis C Transmission;Hospitals;Human Genetics;Human Papillomavirus;implementation intervention;implementation research;implementation science;implementation trial;improved;Infusion procedures;innovation;inter-institutional;Intervention;Intervention Studies;Intervention Trial;Investments;Kentucky;Knowledge;Leadership;lung cancer screening;Malignant Neoplasms;malignant oropharynx neoplasm;member;Mission;Modeling;Molecular;molecular marker;molecular oncology;NCI Center for Cancer Research;novel;Obesity;Oncology;oncology program;Outcome;Patient-Focused Outcomes;Patients;Peer Review;Pilot Projects;Policies;Policy Research;population based;Population Sciences;Population Study;prevent;Prevention;Prevention Guidelines;Prevention program;Process;programs;Public Health;Quality of life;racial minority population;Radon;recruit;Regulation;Research;Research Personnel;Research Priority;Resources;Risk;Risk Factors;risk stratification;routine care;Rural;Science;Science Policy;Screening for cancer;screening guidelines;screening program;smoke-free policy;Smokeless Tobacco;success;Survivors;survivorship;Technology;Testing;Tobacco;tobacco flavor;tobacco products;tobacco regulation;Tobacco Use Cessation;Translating;translational oncology;translational pipeline;Treatment Efficacy;treatment risk;Universities;Vulnerable Populations;Work;Youth

PROJECT_TITLE: Cancer Prevention and Control Research Program


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Bioengineering;Clinical Research;Data Science;Kidney Disease;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Organ Transplantation;Transplantation

ORG_CITY: GAINESVILLE

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF FLORIDA

ORG_STATE: FL

PHR: Project Narrative It is important to improve the outcome of the first transplants in renal transplant recipients via intelligent management, therefore, reduce the need for second transplants and optimize organ allocation. However, existing clinical methods are either minimally to moderately predictive or often not predictive of future renal transplant graft function. Toward this goal, an objective framework will be developed via quantifying chronic changes in digital high-resolution renal transplant biopsy images, and integrating the resulting quantified scores with patients’ demographic, clinical, and social determinant of health data in a multimodal framework, using a novel explainable artificial intelligence model, to predict future renal transplant allograft function, and making the tool available on the cloud for end-users in an easy-to-use, plug-&-play form that will facilitate collaborative, distributed training, and prediction.

PI_NAMEs: JEN, KUANG-YU ;SARDER, PINAKI  (contact)

PROGRAM_OFFICER_NAME: GOSSETT, DANIEL ROBERT

PROJECT_TERMS: Address;Agreement;Allografting;analytical method;Area;artificial intelligence model;Atrophic;Attention;Automation;Benchmarking;Biopsy;Categories;Chronic;Clinical;Clinical Data;cloud based;cohort;Collection;Computer Vision Systems;computerized tools;Data;Data Analyses;data-driven model;deep learning model;demographics;Diagnosis;Diagnostic;Dialysis procedure;digital;digital imaging;digital pathology;Disease Progression;empowerment;End stage renal failure;Event;explainable artificial intelligence;Feedback;Fibrosis;field study;Future;Glomerular Filtration Rate;glomerulosclerosis;Goals;graft dysfunction;graft function;health assessment;health data;Image;Image Analysis;implantation;improved;improved outcome;indexing;Injury to Kidney;Internet;interoperability;interstitial;Kidney;kidney allograft;kidney biopsy;Kidney Transplantation;large-scale imaging data;Learning;Machine Learning;machine learning method;Maryland;Measures;Methods;Modality;Modeling;multi-task learning;multimodality;novel;Organ;organ allocation;Organ Donor;Outcome;outcome prediction;Pathologist;Pathology;Patients;Pattern;Performance;Play;post-transplant;pre-trained transformer;prognostic model;Protocols documentation;Quality of life;recruit;Research Personnel;Resolution;second transplant;Semantics;social health determinants;standard of care;Surgeon;Testing;Time;tool;Training;transplant centers;Transplant Recipients;Transplant Surgeon;Transplantation;treatment strategy;Tubular formation;usability;user-friendly;Vascular Diseases;Visual;web-based tool;whole slide imaging;Work

PROJECT_TITLE: Computational Image Analysis of Renal Transplant Biopsies to Predict Graft Outcome

STUDY_SECTION: CDMA

STUDY_SECTION_NAME: Clinical Data Management and Analysis Study Section[CDMA]


NIH_SPENDING_CATS: Biotechnology;Cancer;Childhood Leukemia;Hematology;Orphan Drug;Pediatric;Pediatric Cancer;Rare Diseases

PHR: Project Narrative My research is focused on developing new therapeutic agents and finding the best way of treating pediatric leukemias. I take on leadership roles to promote clinical trials. I am also devoted to mentoring and training the next generation of doctors, including fellows, residents and medical students.

PI_NAMEs: HIJIYA, NOBUKO  (contact)

PROGRAM_OFFICER_NAME: MAHER, MOLLY ELIZABETH

PROJECT_TERMS: Child;Childhood;Childhood Leukemia;Clinical Research;Clinical Trials;Collaborations;Developmental Therapeutics Program;Disease remission;Dose;Faculty;Goals;improved;interest;Lead;Leadership;Marketing;Medical Students;Mentors;Methods;minority patient;Myeloproliferative disease;next generation;novel;novel therapeutics;Nursing Research;Pediatric Oncology;Pediatric Oncology Group;Physicians;Positioning Attribute;Research;Research Personnel;Role;Specialist;Therapeutic Agents;Therapeutic Clinical Trial;Therapeutic Studies;Therapeutics Committee;Training;Tyrosine Kinase Inhibitor

PROJECT_TITLE: Clinical Trials Specialist in Developmental Therapeutics


NIH_SPENDING_CATS: Biotechnology;Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Gene Therapy;Gene Therapy Clinical Trials;Genetics;Immunotherapy;Neurosciences;Orphan Drug;Rare Diseases

PHR: Project Narrative Based on our preclinical data, we will develop a novel immuno-gene therapy approach in which the expression of chimeric antigen receptor (CAR) is restrictedly and transiently induced in the central nervous system (CNS). This approach allows the therapeutic T cells to overcome the current significant issues of off-tumor/on-target toxicity, antigen heterogeneity, and exhaustion due to the tonic signals. In the current SPORE Project 3 application, we will conduct a first-in-human phase I trial in patients with glioblastoma, including a surgical arm, to determine optimal dosing based not only on tolerability but also on the assessment of infiltration, priming, and function of the infused therapeutic T cells in the glioblastoma tissue.

PI_NAMEs: OKADA, HIDEHO  (contact)

PROJECT_TERMS: Adjuvant;Adopted;Adult Glioblastoma;Antigens;arm;Body System;Brain Neoplasms;brevican;CAR T cell therapy;Cell surface;Cells;Central Nervous System;Central Nervous System Neoplasms;chimeric antigen receptor;chimeric antigen receptor T cells;Clinical;cohort;comparison control;cytotoxic;Data;design;Development;Dose;effective therapy;Eligibility Determination;engineered T cells;Ephrins;Epidermal Growth Factor Receptor;epidermal growth factor receptor VIII;Excision;exhaust;exhaustion;first-in-human;Functional disorder;functional improvement;Glioblastoma;Glioma;Good Manufacturing Process;Grant;Heterogeneity;Homing;immuno-gene therapy;Immunocompetent;immunoregulation;improved;Infiltration;innovation;interleukin-13 receptor;Intravenous;Intravenous infusion procedures;Investigational Drugs;Mediating;MGMT gene;Modeling;mouse model;Mus;neoplastic cell;Nervous System;Neuroglia;Neurons;Newly Diagnosed;notch protein;novel;Operative Surgical Procedures;Organ;patient derived xenograft model;patient population;Patients;PD-1 blockade;phase 1 study;Phase I Clinical Trials;phase I trial;Phenotype;pre-clinical;programmed cell death ligand 1;prospective;Proteoglycan;receptor;Receptor Activation;Recommendation;Recurrence;Regimen;Reporting;Resected;Resistance;resistance mechanism;Safety;screening;Signal Transduction;System;T cell therapy;T-Lymphocyte;Target Populations;Testing;Time;Tissues;Toxic effect;tumor;Tumor Tissue;tumor xenograft

PROJECT_TITLE: Project 3: Novel B-SYNC T cell therapy with CNS-specific expression of CAR as a safe and effective therapy for glioblastoma


NIH_SPENDING_CATS: Cancer;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Prevention

PI_NAMEs: PLATTNER, RINA  (contact)

PROJECT_TERMS: Address;Adhesions;Agriculture;Area;Arts;Automobile Driving;base;Bioenergetics;Biogenesis;Biology;Cancer Burden;cancer cell;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer health disparity;cancer initiation;cancer prevention;cancer stem cell;cancer therapy;Caregivers;Catchment Area;Cell Proliferation;Cell Survival;cellular oncology;Chromatin;Clinic;clinical translation;Clinical Trials;Collaborations;college;Colorectal Cancer;Communication;community engagement;Community Outreach;Development;diagnostic biomarker;Direct Costs;Disparity;DNA Repair;Education;Electronics;Engineering;Ensure;Environment;Enzymes;Epigenetic Process;epigenetic regulation;Epithelium;Extracellular Matrix Proteins;extracellular vesicles;faculty mentor;FASN gene;FDA approved;Food;Funding;Future;Genetic;Genomic Instability;Goals;Heart Injuries;immune checkpoint blockade;Incidence;inter-institutional;Interdisciplinary Study;Intervention;Invaded;Joints;Kentucky;Leadership;Maintenance;Malignant - descriptor;Malignant Neoplasms;Manuscripts;Medicine;member;Mesenchymal;Metabolic;Metabolism;Metastatic Melanoma;microbiome;Mission;Mitochondria;Modeling;Molecular;molecular oncology;mortality;multidisciplinary;NCI Center for Cancer Research;Neoplasm Metastasis;neoplastic cell;Normal tissue morphology;novel;novel therapeutic intervention;Oncogenic;oncology program;Oxidation-Reduction;Pathway interactions;Patients;Peer Review;Phosphoric Monoester Hydrolases;Phosphotransferases;Population;Prevention;Production;Productivity;programs;Protein Kinase;Protein phosphatase;Publications;Publishing;Reactive Oxygen Species;recruit;Recurrence;Regulation;Research;Research Personnel;Research Priority;Resistance;Science;Signal Transduction;Signaling Molecule;Specialist;stem cell biology;Stress;Survivors;therapeutic target;therapy resistant;tissue injury;Tissues;Toxic effect;Translating;translational oncology;translational pipeline;Treatment Efficacy;tumor;tumor immunology;tumor initiation;tumor metabolism;tumor microenvironment;tumor progression;Universities;Vulnerable Populations

PROJECT_TITLE: Molecular and Cellular Oncology Research Program


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Data Science;Dementia;Genetics;Human Genome;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Patient Safety;Precision Medicine;Prevention

ORG_CITY: BOSTON

ORG_NAME: MASSACHUSETTS GENERAL HOSPITAL

ORG_STATE: MA

PHR: Project Narrative Repurposing existing FDA-approved drugs is one approach to accelerating proof-of-concept and ultimately therapeutic clinical trials for Alzheimer's disease (AD). We propose to continue our bioinformatics campaign, parallel to a traditional drug campaign, using available expression data from AD brains in the public domain as our “laboratory” and electronic heath records (EHR) as our “clinical trial infrastructure”. Resulting data packages from these analyses will be shared on Open Science platforms and will help to prioritize follow on clinical and translational studies, which has lead to a new clinical trial.

PI_NAMEs: ALBERS, MARK W (contact);SORGER, PETER KARL

PROGRAM_OFFICER_NAME: ARUNKUMAR, NANDINI

PROJECT_TERMS: Accelerated Phase;Acceleration;Affinity;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's Disease Pathway;Alzheimer's disease patient;Alzheimer's disease related dementia;Award;Awareness;Big Data;biobank;Bioinformatics;Biological Markers;Biology;Brain;Brain region;candidate identification;cell type;Cells;Chemicals;cheminformatics;Clinical;clinical care;Clinical Investigator;Clinical Research;Clinical Trials;Clinical Trials Design;clinically relevant;Collaborations;Communities;Compensation;computer science;Computer software;Computer Systems;computerized tools;cost;Data;Data Set;Databases;Dementia;dementia care;Diagnosis;Disease;Disease Progression;drug action;drug candidate;Drug Prescriptions;drug repurposing;Drug Targeting;Drug usage;Economics;Electronic Health Record;Evaluation;Event;Exons;FDA approved;federated learning;gene discovery;Gene Expression;Gene Expression Profile;Genetic Complementation Test;Genome;Human;imaging study;improved;Individual;Industry;Inflammatory;Informatics;Infrastructure;inhibitor;interoperability;Israel;Kidney Failure;kinase inhibitor;Knowledge;Laboratories;large datasets;Lead;Literature;Machine Learning;Medicine;meetings;member;Mendelian randomization;Methodology;Methods;Modeling;multidisciplinary;National Health Services;Neurofibrillary Tangles;Neuroglia;Neurons;New Agents;novel;Onset of illness;open data;open source;Outcome;Pathologic;Pathology;Pathway Analysis;Pathway interactions;patient population;Patients;Pattern;Peripheral;Pharmaceutical Preparations;Pharmacology;Phase II Clinical Trials;phase III trial;Phenotype;Placebo Control;predictive marker;preference;prevent;Prevention;Production;programs;prospective;protein expression;protein TDP-43;Proteome;Proteomics;Proxy;Public Domains;Randomized;Records;Reproducibility;response;Risk;Running;Signal Transduction;Single Nucleotide Polymorphism;Site;Statistical Data Interpretation;Symptoms;Synapses;System;Target Populations;Testing;Therapeutic;Therapeutic Clinical Trial;tool;transcriptome;transcriptome sequencing;translational study;Update;Work

PROJECT_TITLE: Harnessing Diverse Bioinformatic Approaches To Repurpose Drugs For Alzheimers Disease And Related Dementias


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Chronic Pain;Comparative Effectiveness Research;Neurosciences;Opioids;Pain Research

ORG_CITY: DURHAM

ORG_DEPT: PEDIATRICS

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PHR: The Helping to End Addiction Long-term (HEAL) initiative is a trans-agency effort to find scientific solutions to the national opioid crisis. As part of this initiative, the Duke/Vanderbilt Trial Innovation Center (TIC) will function as the Clinical Coordinating Resource Center (CCRC) and work with TICs at University of Utah and Johns Hopkins/Tufts to provide integrated scientific guidance, coordination, and execution of trials for the NIH HEAL Pain Management Effectiveness Research Network (HEAL Pain ERN).

PI_NAMEs: BENJAMIN, DANIEL K. (contact);GREENBERG, RACHEL G

PROGRAM_OFFICER_NAME: VALLEJO, YOLANDA F

PROJECT_TERMS: Acute pain management;addiction;chronic pain;Clinical;Clinical Research;Clinical Trials;Clinical Trials Network;Collaborations;Collection;comparative effectiveness trial;Data;Data Analyses;Dedications;design;Dose;effectiveness research;Funding;Future;Helping to End Addiction Long-term;Infrastructure;innovation;Institutional Review Boards;Leadership;Longitudinal Studies;Monitor;National Center for Advancing Translational Sciences;Opioid;opioid epidemic;Pain;Pain Clinics;Pain management;Phase;prevention effectiveness trial;Principal Investigator;Protocols documentation;Public Health;Publications;recruit;Regimen;Research Institute;Research Personnel;Resources;response;Risk Reduction;Safety;Sickle Cell Anemia;Speed;success;Translational Research;trial design;U-Series Cooperative Agreements;United States National Institutes of Health;Universities;Utah;Work;Writing

PROJECT_TITLE: HEAL Clinical Coordinating Resource Center for the Pain Management Effectiveness Research Network


NIH_SPENDING_CATS: Biotechnology;Cancer;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Precision Medicine;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

PI_NAMEs: KOLESAR, JILL MARIE (contact)

PROJECT_TERMS: Address;anti-cancer treatment;Antineoplastic Agents;Appalachian Region;Area;Award;Basic Science;Biological Markers;Biological Models;Breast;Cancer Burden;cancer care;Cancer Center;Cancer Center Support Grant;Cancer Control;Cancer Patient;cancer prevention;cancer therapy;Catchment Area;cellular oncology;Clinic;Clinical;clinical development;Clinical Oncology;clinical translation;clinical trial enrollment;Clinical Trials;Clinical Trials Network;clinically relevant;Collaborations;college;Colorectal Cancer;Communities;community engagement;Community Outreach;cross disciplinary program;Data;design;Development;Devices;Diet;Direct Costs;Disparity;drug repurposing;Early identification;early phase clinical trial;Early Therapeutic-Clinical Trials Network;EIF4EBP1 gene;Electronics;Enrollment;ethnic disparity;FASN gene;Fostering;Funding;Future;genome resource;Genomics;Goals;Gold Compounds;Hydroxychloroquine;Incidence;Individual;Infrastructure;inhibitor;insight;Institution;inter-institutional;Interdisciplinary Study;International;intervention program;Intestinal Hormones;Investigational Drugs;Investigational Therapies;investigator-initiated trial;Kentucky;Lead;Leadership;Malignant Neoplasms;Manuscripts;Mediator;member;Mission;Molecular;molecular oncology;Molecular Target;mortality;Multi-Institutional Clinical Trial;Mutation;National Cancer Institute;Natural Products;NCI Center for Cancer Research;next generation sequencing;novel;novel anticancer drug;novel therapeutic intervention;novel therapeutics;Nursing Faculty;Obesity;Oncology;oncology program;Participant;Patient-Focused Outcomes;Patients;Peer Review;Pharmaceutical Preparations;Phase;phase 1 study;Phenotype;Population;pre-clinical;precision medicine;preclinical development;programs;Prostate;Public Policy;Publications;Publishing;racial disparity;Radiopharmaceuticals;recruit;repository;Research;Research Personnel;Research Priority;Resources;Role;Ruthenium Compounds;Science;Strategic Planning;Structure;Therapeutic;Therapeutic Agents;Therapeutic Intervention;Translating;translational goal;translational oncology;translational pipeline;translational study;Translations;treatment trial;tumor;Tumor Suppressor Proteins;United States National Institutes of Health;Universities;Up-Regulation;Validation;working group

PROJECT_TITLE: Translational Oncology Research Program


NIH_SPENDING_CATS: Biotechnology;Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Neurosciences;Rare Diseases

PI_NAMEs: PHILLIPS, JOANNA  (contact)

PROJECT_TERMS: analysis pipeline;Animal Model;Animals;biobank;Biological Assay;biological specimen archives;Biometry;Brain Neoplasms;Cell Survival;Clinical;clinical database;Clinical Trials;computerized;Confidentiality of Patient Information;Data;Databases;Dedications;Development;DNA;Drug or chemical Tissue Distribution;Ensure;Equipment and supply inventories;Funding;Genomics;Goals;Grant;Guidelines;Human;Image Analysis;Immunoassay;In Situ Hybridization;Informed Consent;Institution;Ischemia;Leadership;Link;member;Mission;Molecular;Molecular Analysis;multimodality;National Cancer Institute;neuro-oncology;neuropathology;novel;Operating Rooms;Pathology;Patients;Pre-Clinical Model;Preparation;preservation;Procedures;Process;Proteins;Proteomics;Quality Control;quantitative imaging;Regulation;Research;Research Project Grants;RNA;Scanning;Science;Signal Pathway;Slide;Standardization;success;System;Techniques;Technology;Time;Tissue Microarray;tissue/cell culture;Tissues;transcriptomics;Translational Research;vaccine development;Validation;whole slide imaging;Xenograft procedure

PROJECT_TITLE: Core 1: Biospecimen and Pathology Core


ADMINISTERING_IC: VA

IC_NAME: Veterans Affairs

ORG_CITY: St. Louis

ORG_NAME: ST. LOUIS VA MEDICAL CENTER

ORG_STATE: MO

PHR: Diabetes leads to devastating consequences including death due to heart and kidney disease. Compared to placebo, newer therapies for diabetes, including sodium-glucose co-transporter-2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP1), have been shown to reduce risk of heart and kidney disease in high risk individuals. Whether these benefits hold true when these newer medications are compared to older and cheaper diabetes medications, including dipeptidyl peptidase-4 inhibitors (DPP4) and sulfonylureas, and whether these benefits extend to individuals with intermediate or low risk is not known. In this proposal we will use data from the Department of Veterans Affairs to evaluate the comparative effectiveness of these 4 classes of diabetes drugs on risk of heart disease, kidney disease, and evaluate the risk of adverse events associated with these drug classes. We will also identify the characteristics of patients who stand to derive the most benefit and least risk from each medication class. Results will provide evidence to guide treatment of diabetes.

PI_NAMEs: AL-ALY, ZIYAD  (contact)

PROJECT_TERMS: Accounting;acute pancreatitis;Acute Renal Failure with Renal Papillary Necrosis;Address;Adverse event;adverse event risk;Affect;Age;Agonist;Albumins;Albuminuria;Algorithms;arm;Benefits and Risks;Big Data;Bladder;Body mass index;Cardiovascular Agents;Cardiovascular Diseases;cardiovascular disorder risk;cardiovascular risk factor;Cardiovascular system;Caring;Categories;Cessation of life;Characteristics;Chronic Kidney Failure;clinical practice;Clinical Practice Guideline;cohort;comparative;comparative effectiveness;comparative effectiveness trial;comparative safety;Complex;Computerized Medical Record;cost;Creatinine;Data;Diabetes Mellitus;diabetes mellitus therapy;diabetes risk;Diabetic Ketoacidosis;Diagnosis;Dipeptidyl Peptidases;discrete time;Disease Outcome;Disease Progression;Effectiveness;Electronic Health Record;Eligibility Determination;End stage renal failure;Event;falls;follow-up;Fracture;Future;Glomerular Filtration Rate;GLP-I receptor;Glucose;hazard;Health Services Research;Healthcare;heart disease risk;Heart Diseases;Heart failure;high dimensionality;high risk;high risk population;Hospitalization;Hypertension;Hypoglycemia;Hypoglycemic Agents;Incidence;Individual;Informatics;inhibitor;innovation;Intention;Kidney;Kidney Diseases;kidney preservation;Knowledge;Life Style;limb amputation;Lower Extremity;Machine Learning;Metformin;Methodology;Methods;mortality;Myocardial Infarction;New Agents;novel therapeutics;Outcome;Outcome Assessment;Patients;personalized care;Persons;Pharmaceutical Preparations;Pharmacoepidemiology;Placebos;Population;primary care practice;Probability;Protocols documentation;Race;Randomized;randomized trial;randomized, clinical trials;Randomized, Controlled Trials;Reducing Agents;Renal function;Reporting;research and development;Research Priority;Resources;Risk;Risk Assessment;Risk Estimate;Risk Reduction;Safety;Sodium;Specific qualifier value;Stroke;Subgroup;Sulfonylurea Compounds;Survival Analysis;symporter;Time;treatment guidelines;treatment strategy;United States Department of Veterans Affairs;Urinary tract infection;Urine;venous thromboembolism;Veterans;Work

PROJECT_TITLE: Comparative Effectiveness and Safety of Newer and Older Antihyperglycemic Medications

STUDY_SECTION_NAME: HSR-1 Health Care and Clinical Management[HSR1]


NIH_SPENDING_CATS: Biomedical Imaging;Biotechnology;Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Hematology;Neurosciences;Orphan Drug;Patient Safety;Rare Diseases

PROJECT_TERMS: Adverse event;Biometry;Blood;Bone Marrow Transplantation;Brain Neoplasms;Cancer Center;career;Cell Therapy;Clinical;Clinical assessments;Clinical Data;Clinical Management;Clinical Nursing Research;Clinical Protocols;Clinical Research;Clinical Trials;Clinical Trials Design;Combined Modality Therapy;Conduct Clinical Trials;Consent;cost effective;Data;Data Analyses;data management;Databases;design;Development;Doctor of Medicine;Doctor of Philosophy;Drug Kinetics;early phase clinical trial;Ensure;experience;Experimental Designs;experimental study;Genomics;Grant;Hematology;Human;Human Resources;Image;imaging study;Imaging Techniques;improved;Individual;Infrastructure;Institution;Intervention;Knowledge;Laboratories;Leadership;Link;metabolic imaging;Methods;molecular subtypes;Monitor;neuroimaging;non-invasive imaging;novel;Outcome;Patients;Performance;Pharmaceutical Preparations;Pharmacodynamics;Phase;Population Sciences;Preparation;Procedures;Prognostic Marker;prognostic value;programs;prospective;Protocols documentation;Publications;Qualifying;Reporting;repository;Research;Research Personnel;Research Project Grants;research study;Research Support;Resources;Safety;Specific qualifier value;Standardization;Statistical Models;Supervision;Testing;Therapeutic;Tissue Banks;Tissues;Toxic effect;Translational Research;transplantation therapy;treatment response;Tumor Burden;Tumor Tissue;validation studies;Work

PROJECT_TITLE: Core 2: Biostatistical and Clinical Core


NIH_SPENDING_CATS: Cancer;Prevention

PHR: Project Narrative  Not applicable. This document is attached to satisfy electronic submission requirements.

PI_NAMEs: EVERS, BERNARD MARK (contact)

PROJECT_TERMS: Address;anti-cancer research;Area;Basic Science;Cancer Burden;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer education;cancer genomics;cancer prevention;cancer research center director;Catchment Area;Clinical;clinical care;Clinical Research;clinical translation;Communities;community engagement;community organizations;Community Outreach;Comprehensive Cancer Center;Consultations;Development;diversity and inclusion;Education;Effectiveness;Electronics;Ensure;Epidemiologist;Equity;equity, diversity, and inclusion;Evaluation;experience;Fostering;functional status;Funding;Future;Goals;Growth;Healthcare;improved;Infrastructure;Institution;Intervention Trial;Investments;Kentucky;Lead;Leadership;Legal patent;Malignant Neoplasms;meetings;Mentors;Mission;Molecular;Names;NCI Center for Cancer Research;Needs Assessment;novel therapeutics;outreach;patient oriented;Patients;Population Sciences;Positioning Attribute;Preparation;Prevention;Process;programs;Recording of previous events;recruit;Reporting;Research;Research Personnel;Resource Sharing;Resources;Scientist;Secure;Source;Strategic Planning;success;Time;Training;Training and Education;translational pipeline;translational scientist;tumor metabolism;Universities;University resources;Vision;Vulnerable Populations;Work

PROJECT_TITLE: Leadership, Planning and Evaluation


NIH_SPENDING_CATS: Behavioral and Social Science;Cardiovascular;Clinical Research;Diabetes;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Hypertension;Networking and Information Technology R&D (NITRD);Primary Health Care;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health;Telehealth

ORG_CITY: PORTLAND

ORG_DEPT: FAMILY MEDICINE

ORG_NAME: OREGON HEALTH & SCIENCE UNIVERSITY

ORG_STATE: OR

PHR: PROJECT NARRATIVE Latinos are more likely to have diabetes and hypertension and to face poor outcomes and complications from these diseases. The COVID-19 pandemic has shifted many primary care visits from face-to-face visits to telemedicine (telephone and video) visits, and it is uncertain how frequently Latino patients with diabetes and hypertension utilized (and continue to utilize) these types of visits, and how this may have affected the services they received for diabetes and hypertension. This project will use a highly innovative electronic health record database that contains telemedicine and in-person visit data to understand the quality of diabetes and hypertension care delivered via telemedicine among Latinos.

PI_NAMEs: MARINO, MIGUEL  (contact)

PROGRAM_OFFICER_NAME: FLOURNOY FLOYD, MINNJUAN WYNCEPHEL

PROJECT_TERMS: access disparities;acronyms;Address;Affect;care delivery;care seeking;care systems;Caring;Chronic Care;Chronic Disease;Communities;Community Health Education;Community Health Networks;comorbidity;COVID-19 pandemic;Data;Data Set;Databases;Decision Making;diabetes management;Diabetes Mellitus;Disease;Disease Outcome;Disparity;disparity reduction;Drug Prescriptions;Economics;Education;Educational Status;Effectiveness;Electronic Health Record;Ensure;Equitable healthcare;Equity;Evaluation;Face;health care availability;health care delivery;health inequalities;Health Insurance;Health Services Accessibility;Health system;Healthcare;Healthcare Systems;Hypertension;Immigration;improved;Individual;Inequity;innovation;Internet;Knowledge;Language;Latino;Latino Population;Link;Managed Care;member;Minority Groups;Monitor;Morbidity - disease rate;mortality;Neighborhood Health Center;Not Hispanic or Latino;Outcome;pandemic disease;patient oriented;Patients;Persons;Policies;Policy Maker;poor communities;Population;Prevention;Primary Care;primary care services;primary care visit;Quasi-experiment;Recommendation;Regulation;Relaxation;Research Design;Resources;Risk;risk stratification;rurality;safe patient;screening;Services;social;Social Distance;social factors;social health determinants;Spanish;Technology;Telemedicine;Telephone;Training;United States;Virus;Visit;World Health Organization

PROJECT_TITLE: E-TREAT: Evaluation of Telemedicine for diabetes care in Latinos

STUDY_SECTION: HHD

STUDY_SECTION_NAME: Healthcare and Health Disparities Study Section[HHD]


FUNDING_MECHANISM: SBIR-STTR RPGS

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Nanotechnology;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_CITY: CAMBRIDGE

ORG_NAME: TIBA BIOTECH, LLC

PHR: Project Narrative Development of a vaccine against Avian Influenza A H7N9, which has a high mortality rate in humans and has raised concerns over its pandemic potential, will have a major impact on prevention of pandemic disease and its associated economic disruption. We propose to produce a multi-antigen RNA-based vaccine against H7N9, utilizing a novel and innovative delivery method that will solve many challenges hindering conventional pandemic vaccine development, such as long lead-times for scale-up and the need for flexibility to allow substitution of alternative sequences to match emerging strains. The proposed vaccine product is expected to confer greater protection by incorporating multiple influenza virion antigens simultaneously, and its modular design allows it to be easily applied to other high-risk Influenza pandemic or seasonal strains.

PI_NAMEs: CHAHAL, JASDAVE  (contact)

PROGRAM_OFFICER_NAME: GORDON, JENNIFER L

PROJECT_TERMS: Acute;Adjuvant;Antigens;Avian Influenza;BALB/cJ Mouse;Biodistribution;Biotechnology;Bird Flu vaccine;Cells;Clinical;Clinical Trials;cold temperature;commercialization;COVID-19 impact;COVID-19 pandemic;Death Rate;design;Development;Disease Outbreaks;Dose;Economics;experimental study;Ferrets;flexibility;Formulation;Future;Generations;Goals;Health;Hemagglutinin;High Pressure Liquid Chromatography;high risk;Human;Immune response;Immunity;Immunization;Immunize;immunogenic;immunogenicity;in vivo;Inflammatory;Inflammatory Response;Influenza;Influenza A virus;Influenza A Virus, H7N9 Subtype;influenza virus vaccine;innovation;Intramuscular;Lead;Libraries;lipid nanoparticle;manufacture;Marketing;Measures;meetings;method development;Methods;Modeling;Monitor;mortality;mouse model;multimodality;Mus;nanoparticle delivery;Neuraminidase;new technology;novel;Nucleic Acids;Nucleoproteins;Organ;pandemic disease;pandemic influenza;pandemic potential;Phase;phase 1 study;point of care;pre-Investigational New Drug meeting;prevent pandemics;Process;protective efficacy;Proteins;prototype;Quality Control;Rattus;Readiness;Refrigeration;Regimen;Replicon;Reporting;Research;respiratory;response;RNA;RNA Degradation;RNA purification;RNA vaccine;Rodent Model;Safety;safety assessment;scale up;Seasons;Signal Transduction;Technology;Toxic effect;uptake;vaccine candidate;vaccine development;vaccine efficacy;vaccine evaluation;vaccine safety;Vaccines;Virion;Virus;Zoonoses

PROJECT_TITLE: Rapid response to pandemic influenza via multi-antigen RNA-based vaccine

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-DCAI-D(10)]


NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Cardiovascular;Genetics;Health Disparities and Racial or Ethnic Minority Health Research;Heart Disease;Human Genome;Patient Safety;Precision Medicine;Racial and Ethnic Minority Health Research;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: PALO ALTO

ORG_NAME: GREENSTONE BIOSCIENCES, INC.

PHR: NARRATIVE All new drug candidates must be screened for potential cardiac toxicities before being given to patient. Current drug screening technologies fail to consider the differences between men and women, and differences between different ethnic groups or the fact that people with genetic cardiac abnormalities account for most drug failures; this results in an enormous cost in terms of late-stage drug development failures and patient morbidity/mortality. Greenstone Biosciences has the world's largest collection of induced pluripotent stem cell lines, and the purpose of this application is to develop a subset of these into a validated panel for drug screening and drug discovery that for the first time reflects the heterogeneity of the population at large.

PI_NAMEs: AHMED, SYED MUKHTAR (contact)

PROGRAM_OFFICER_NAME: POIZAT, CORALIE ISABELLE

PROJECT_TERMS: Acceleration;African American population;Age;American Heart Association;Anthracycline;Antineoplastic Protocols;Area;Arrhythmia;Biological Sciences;Biotechnology;Breast Cancer Treatment;Calcium;Cardiac;Cardiac Myocytes;Cardiotoxicity;Cardiovascular Agents;Cardiovascular system;Caucasians;Cell Line;Cell Survival;cell type;Cells;Characteristics;chemotherapeutic agent;Client;Clinical;Clinical Trials;Coculture Techniques;Collaborations;Collection;Communities;Computational Biology;cost;Cryopreservation;Data;Dedications;Development;Disease;DNA Damage;dosage;Dose;Doxorubicin;drug candidate;drug development;drug discovery;drug efficacy;Drug Industry;Drug Screening;Drug toxicity;East Asian;Economics;Electrophysiology (science);Ensure;ethnic diversity;Ethnic Origin;Ethnic Population;Evaluation;Failure;Gene Expression;Genetic;genome sequencing;genome-wide;Genomics;Grant;Health Personnel;Heart Abnormalities;high risk;Hispanic Populations;Hour;human induced pluripotent stem cells;Image;in vitro Model;Individual;individual variation;induced pluripotent stem cell;induced pluripotent stem cell derived cardiomyocytes;inter-individual variation;interest;Investments;Karyotype determination procedure;Laboratories;Libraries;Malignant Neoplasms;Marketing;Medical;medication safety;men;Metabolic;Metabolism;Modeling;Morbidity - disease rate;mortality;multi-electrode arrays;multiple omics;novel therapeutics;patient population;patient retention;patient stratification;Patients;Pattern;Persons;Pharmaceutical Preparations;Pharmacogenomics;Pharmacologic Substance;Pharmacotherapy;Pharmacy (field);Population;Population Genetics;Population Heterogeneity;precision medicine;predictive modeling;Predisposition;Production;professor;Protocols documentation;Quantitative Trait Loci;Reactive Oxygen Species;Reporting;Research;Research Personnel;Resources;responders and non-responders;response;Risk;Safety;safety testing;Sampling;Sarcomeres;scale up;screening;sex;side effect;single-cell RNA sequencing;Small Business Innovation Research Grant;South Asian;Technology;Testing;Time;tool;Toxicity Tests;Transcription Initiation Site;transcriptomics;Translating;whole genome;Woman;Work

PROJECT_TITLE: Ethnically Diverse iPSC-Cardiomyocyte Panel for Pharmacogenomics and Drug Safety Testing


NIH_SPENDING_CATS: Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Neurosciences;Rare Diseases

PHR: Project Narrative The Developmental Research Program is required component of all SPOREs and must be maintained for the entire funding period. The UCSF Brain Tumor SPORE commits $100,000 per year to the DRP in support of research that facilitates the goals of the program. Another $50,000 per year is provided by funds from the UCSF Department of Neurological Surgery through the Helen Diller Family Comprehensive Cancer Center (HDFCCC), allow the SPORE to provide $50,000 direct costs for up to three DRP projects per year.

PI_NAMEs: COSTELLO, JOSEPH F (contact)

PROJECT_TERMS: Academy;Award;Brain Neoplasms;Cells;Collaborations;Comprehensive Cancer Center;CRISPR/Cas technology;Development;Direct Costs;Family;Funding;Genetic;Glioma;Goals;Grant;high risk;Institution;Journals;Medicine;Monitor;Nature;Neurosciences;Neurosurgical Procedures;new technology;Peer Review;Pilot Projects;Program Research Project Grants;programs;Publications;Research;Research Project Grants;Research Support;Resources;Science;Scientist;translational medicine;Translational Research;United States National Institutes of Health;Work

PROJECT_TITLE: Developmental Research Program (DRP)


NIH_SPENDING_CATS: Clinical Research;Hematology

ORG_CITY: CINCINNATI

ORG_NAME: OGB4 INC

ORG_STATE: OH

PHR: NARRATIVE Hematology/oncology and trauma patients with low platelet counts often require platelet transfusion, and this is crucial in the treatment of patients with cancer or hematologic diseases. The development of a method to prevent platelet damage upon refrigeration is a dream in blood banking and it would revolutionize the current method of platelet storage. The proposal intends to develop a method to store fully functional platelets by refrigeration and will move a novel regimen for platelet cold storage to FDA IND filing and commercialization.

PI_NAMEs: CANCELAS, JOSE A.;DE KOUCHKOVSKY, BRITTANY  (contact);ZHENG, YI

PROGRAM_OFFICER_NAME: FRANK, DANIEL J

PROJECT_TERMS: Animals;Authorization documentation;Biochemistry;Birth;Blood;Blood Banks;Blood Platelets;Blood Transfusion;Blood Vessels;burn therapy;Canis familiaris;clinical development;Clinical Trials;Coagulation Process;commercialization;Complex;cost efficient;Cryopreservation;Data;Development;Dose;Dreams;Drug Kinetics;enantiomer;Equipment and supply inventories;Erythrocytes;Evaluation;Excretory function;exposed human population;Funding;Generations;Genes;Genetic;Guanosine Triphosphate Phosphohydrolases;Hematological Disease;Hematology;Hemorrhage;Hemostatic Agents;Hemostatic function;Hepatocyte;HIV;Hospitals;Hour;Human;improved;in silico;In Vitro;in vivo;inhibitor;Investigation;Kidney;Kinetics;Lesion;Life;Macaca mulatta;Macrophage;Malignant Neoplasms;Marketing;Measures;Medical;Medical center;Metabolic;Metabolic Pathway;metabolic profile;Methods;Microsomes;Modeling;Molecular;Monkeys;Mus;nonhuman primate;novel;novel therapeutics;Oncology;Operative Surgical Procedures;pathogen;Patients;Pediatric Hospitals;Phagocytosis;Phagocytosis Inhibition;pharmacologic;Phase;Phenotype;Plasma;Platelet Count measurement;platelet storage;Platelet Transfusion;pre-clinical;preclinical safety;Pregnancy;Preparation;preservation;prevent;Prevention;Rattus;Reaction;receptor;Recovery;Refrigeration;Regimen;repaired;Reporting;Resuscitation;rho GTP-Binding Proteins;RHOA gene;Risk;Rodent;Route;Safety;safety assessment;Small Business Innovation Research Grant;Survival Rate;System;Technology;Temperature;Toxic effect;Toxicology;Transfusion;Translating;Transplantation;Trauma;Trauma patient;United States Food and Drug Administration;United States National Institutes of Health;Work

PROJECT_TITLE: Rho GTPase inhibitor for refrigerated platelet storage


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Prevention

PROJECT_TERMS: Address;anti-cancer research;Area;Award;Basic Science;Cancer Burden;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer genomics;cancer prevention;cancer research center director;Cancer Research Project;Catchment Area;cellular oncology;Clinical;Clinical Cancer Center;clinical center;Clinical Research;Clinical Sciences;Clinical Trials;clinically relevant;Collaborations;Colorectal Cancer;Communities;community advisory board;community engagement;Community Participation;Comprehensive Cancer Center;Data;Dedications;design;Development;Ecosystem;Education;Electronics;Ensure;Evaluation;evidence base;Extramural Activities;flexibility;Fostering;Funding;Funding Agency;Future;Goals;Grant;Guidelines;health disparity;innovation;Institution;interest;Investments;Kentucky;Leadership;Link;member;Mission;Molecular;molecular oncology;National Cancer Institute;NCI Center for Cancer Research;novel;Obesity;Participant;patient oriented;Philanthropic Fund;Pilot Projects;Population;Population Sciences;Prevention;Process;Program Description;Program Research Project Grants;programs;Racial Equity;recruit;Recurrence;Research;Research Personnel;Research Priority;Research Project Grants;Research Support;Resource Allocation;Resource Sharing;Resources;Science;screening;Secure;Strategic Planning;translational cancer research;translational oncology;Translational Research;Universities;Vision;Vulnerable Populations;Work

PROJECT_TITLE: Developmental Funds


PHR: Project Narrative The Career Enhancement Program is required component of all SPOREs and must be maintained for the entire funding period. The UCSF Brain Tumor SPORE commits $100,000 per year to the CEP in support of research that facilitates the goals of the program. Another $50,000 per year is provided by funds from the UCSF Department of Neurological Surgery through the Helen Diller Family Comprehensive Cancer Center (HDFCCC), allowing the SPORE to fund up to three CEP projects per year

PROJECT_TERMS: Brain Neoplasms;career;Comprehensive Cancer Center;Family;Funding;Funding Mechanisms;Goals;Grant;Individual;Mentors;minority investigator;Neurosurgical Procedures;Process;programs;Recording of previous events;Research;Research Personnel;Research Support;Source;Underrepresented Minority;United States National Institutes of Health;Woman;Work

PROJECT_TITLE: Career Enhancement Program (CEP)


NIH_SPENDING_CATS: Chronic Obstructive Pulmonary Disease;Climate-Related Exposures and Conditions;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Cost Effectiveness Research;Health Effects of Household Energy Combustion;Health Effects of Indoor Air Pollution;Health Services;Lung;Prevention;Social Determinants of Health;Tobacco;Tobacco Smoke and Health

ORG_CITY: BALTIMORE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

ORG_STATE: MD

PHR: PROJECT NARRATIVE COPD is a leading cause of death and morbidity worldwide and is attributable to the aggregate burden of toxic gases and particles that individuals inhale during their lifetime. Particulate matter (PM) and nitrogen dioxide (NO2) are common pollutants in indoor environments where adults with COPD spend >90% of their time. We propose a Phase III multi-center randomized sham-controlled trial to test the effectiveness of an air cleaner intervention targeting indoor pollutants (PM and NO2) on quality of life and exacerbation risk reduction among former smokers with COPD (n~770) across multiple clinical practice locations.

PI_NAMEs: EHRHARDT, STEPHAN  (contact)

PROGRAM_OFFICER_NAME: POSTOW, LISA

PROJECT_TERMS: Acute;Address;Adherence;Adult;Air;air cleaner;airway epithelium;airway inflammation;Baltimore;burden of illness;Carbon;Caring;Cause of Death;Chronic;Chronic Obstructive Pulmonary Disease;cigarette smoke;Clinical;Clinical effectiveness;clinical efficacy;clinical practice;combustion product;Complex Mixtures;Controlled Clinical Trials;cost effective;cost effectiveness;Cost Effectiveness Analysis;Data;disabling disease;Disease Outcome;Dose;Economic Burden;economic evaluation;economic impact;Economics;effectiveness evaluation;effectiveness testing;Emergency department visit;environmental intervention;EuroQOL;Evidence based intervention;Exposure to;former smoker;Future;Gases;Geographic Locations;Guidelines;Health;health care service utilization;Health Policy;high risk;Home;Hospitalization;improved;incremental cost;Individual;indoor air;Indoor Air Pollution;Indoor environment;indoor particulate matter;indoor pollutant;Inhalation;Intention;International;Intervention;Lead;Link;Literature;Location;markov model;Measurable;Measures;Methods;Morbidity - disease rate;mortality;Nitrogen Dioxide;Nonpharmacologic Therapy;novel strategies;Outcome;Oxidative Stress;Participant;particle;Particulate;Particulate Matter;Patients;Pharmaceutical Preparations;Phase;Policies;pollutant;portability;Prevention;primary endpoint;Protocols documentation;Public Health;Pulmonary Inflammation;Quality of life;Quality-Adjusted Life Years;Questionnaires;Randomized;Randomized, Controlled Trials;Recommendation;recruit;respiratory;respiratory morbidity;Respiratory Signs and Symptoms;response;Risk;Risk Reduction;secondary outcome;Shapes;Smoker;smoking cessation;Societies;Source;Symptoms;systemic inflammatory response;Third-Party Payer;Time;trend;trial design;Viral;Water

PROJECT_TITLE: 2/2 Multi-Center CLEAN AIR 2 Randomized Control Trial in COPD

STUDY_SECTION: CLTR

STUDY_SECTION_NAME: Clinical Trials Review Study Section[CLTR(MA)]


NIH_SPENDING_CATS: Aging;Cancer;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Patient Safety;Rural Health

PI_NAMEs: ARNOLD, SUSANNE M (contact)

PROJECT_TERMS: Adherence;Adult;Age;anti-cancer research;Appalachian Region;Awareness;Biometry;cancer care;Cancer Center;Cancer Center Support Grant;cancer health disparity;Catchment Area;Child Care;Clinical;Clinical Cancer Center;clinical care;Clinical Data;Clinical Management;Clinical Protocols;Clinical Research;Clinical Research Associate;Clinical Trials;Clinical Trials Network;Collaborations;community engagement;Community Outreach;community partners;County;COVID-19 pandemic;Data;Data Collection;data management;Data Management Resources;Dedications;design;Development;Devices;Disease;Education;Electronics;Ensure;Ethnic Origin;experience;Faculty;Female;Gender;Germ Lines;Goals;human old age (65+);Improve Access;improved;Individual;Industry;industry partner;Infrastructure;Institution;Institutional Review Boards;Intervention;Investigational Drugs;Investigational Therapies;investigator-initiated trial;Kentucky;Leadership;life span;Malignant neoplasm of lung;Malignant neoplasm of prostate;Malignant Neoplasms;Minority;Mission;Molecular;Monitor;National Cancer Institute;National Clinical Trials Network;NCI Center for Cancer Research;Needs Assessment;Nurses;Office Management;oncology program;operation;patient engagement;patient oriented;patient population;patient safety;Patients;Pediatric Oncology;Performance;Policies;Population;Procedures;Process;programs;Protocol Compliance;protocol development;Protocols documentation;quality assurance;Race;Reporting;Research;Research Activity;Research Design;Research Personnel;Research Priority;Research Support;Resource Allocation;Resource Sharing;response;Risk;Safety;Services;Site;Special Population;Specialist;success;System;Testing;Therapeutic Trials;Time;tool;Toxic effect;Training;Training and Education;Translational Research;tumor;Underserved Population;United States National Institutes of Health;Universities;Vision;Woman

PROJECT_TITLE: Clinical Protocol and Data Management


NIH_SPENDING_CATS: Behavioral and Social Science;Cardiovascular;Childhood Obesity;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;Health Services;Maternal Health;Maternal Morbidity and Mortality;Nutrition;Obesity;Pediatric;Physical Activity;Pregnancy;Prevention;Primary Health Care;Women's Health Research

ORG_CITY: SAINT LOUIS

ORG_NAME: WASHINGTON UNIVERSITY

PHR: PROJECT NARRATIVE  Nigeria has among the highest burdens of maternal morbidity and mortality in the world, which is coupled with a rising burden of noncommunicable diseases due to unhealthy changes in dietary patterns and physical activity, especially during critical life stages. This study aims to test the effects of implementing an adapted HEALTH (Healthy Eating Active Living Taught at Home) intervention on intergenerational cardiovascular health among women recruited during the antenatal period and their children through a type 2 hybrid cluster randomized trial implemented in Nigerian primary healthcare centers. Improving maternal health behaviors and subsequent maternal cardiovascular health is a central strategy toward improving family cardiovascular health to blunt and eventually reverse the rising burden of noncommunicable diseases in Nigeria.

PI_NAMEs: AKABA, GODWIN OTUODICHINMA;DAVILA-ROMAN, VICTOR G.;HUFFMAN, MARK D (contact);OJJI, DIKE BEVIS

PROGRAM_OFFICER_NAME: BRUNO, FERNANDO PEREIRA

PROJECT_TERMS: active lifestyle;Adopted;Adoption;antenatal;Birth;Body mass index;Body Weight;Body Weight decreased;budget impact;burden of illness;Capital;Cardiac;Cardiovascular Diseases;cardiovascular health;Certification;Child;Childhood;Cluster randomized trial;Collaborations;Communities;Community Health;Community Health Nursing;Coupled;Data;Development;Diabetes Mellitus;Diet;Dietary Practices;Disadvantaged;Discipline of obstetrics;Disease;Education;Educational process of instructing;Educational Status;Effectiveness;effectiveness evaluation;effectiveness outcome;effectiveness testing;Enrollment;Evaluation;evidence base;Family;follow-up;Funding;Funding Opportunities;gestational weight gain;Grant;Growth;Gynecology;Health;Health behavior;Health Educators;Health Policy;Health system;Healthy Eating;Home;Home visitation;Hybrids;Hypertension;implementation outcomes;implementation research;implementation science;improved;infancy;Infant;intergenerational;Intervention;Lead;Life;Live Birth;low and middle-income countries;Maintenance;Maternal Age;Maternal Health;maternal morbidity;Maternal Mortality;maternal weight;member;Methods;Modeling;Modification;Mothers;New York;Nigeria;Nigerian;Nurses;Nursing Faculty;Obesity;Outcome;Outcome Assessment;Overweight;Parents;peri-urban;Perinatal;Physical activity;Policies;post intervention;postpartum weight;pregnancy disorder;Pregnant Women;prenatal;Prevention;Primary Health Care;primary health center;Primary Schools;Public Health;Randomized;Reach, Effectiveness, Adoption, Implementation, and Maintenance;recruit;Reporting;Research;Research Personnel;Rural;Safety;sex;Societies;Subgroup;Sustainable Development;System;teacher;Testing;Trainers Training;Training;trend;trial design;tribal Nation;Uncertainty;United States National Institutes of Health;Universities;Washington;Weight;Woman;Work

PROJECT_TITLE: ENhancing Intergenerational HeAlth in Nigeria: Peripartum as Critical Life StagE for CardioVascular Health (ENHANCE-CVH)

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-HSS-G(50)R]


ORG_DEPT: PSYCHIATRY

ORG_NAME: NEW YORK UNIVERSITY SCHOOL OF MEDICINE

PHR: NARRATIVE The Center on Causal Data Science for Child and Adolescent Maltreatment Prevention (CHAMP Center) is proposed to substantially increase the scale of preventing maltreatment and its devastating consequences for many children at risk. The CHAMP Center will achieve these results through an integrated program of scientific discovery and translation, focused on determining the causal factors producing maltreatment exposures and outcomes and both testing and disseminating strategies for targeted, personalized, and precise interventions.

PI_NAMEs: SAXE, GLENN N (contact)

PROGRAM_OFFICER_NAME: MAHOLMES, VALERIE

PROJECT_TERMS: Accounting;Achievement;Address;Adolescent;Adolescent Psychiatry;Caregivers;Categories;causal model;Child;Child Abuse and Neglect;Child Health;child protection;Child Psychiatry;child services;Collaborations;Community Health Networks;Complex;County;Data Science;Data Scientist;Data Set;design;dissemination science;effective intervention;Ethics;Etiology;Exclusion;Exposure to;Family;Family health status;Functional impairment;implementation science;Intervention;Knowledge;maltreated children;maltreatment;marginalized population;medical schools;Mental Depression;Methods;Minnesota;neglect;Neighborhood Health Center;Outcome;outreach;personalized intervention;physical abuse;Policies;post-traumatic stress;Post-Traumatic Stress Disorders;Poverty;predictive modeling;prevent;Prevention;preventive intervention;Primary Care;Probability;Process;Productivity;programs;psychobiologic;Public Health Informatics;Publishing;Research;Research Personnel;Resources;Risk;Risk Factors;Risk Reduction;Risk Taking;school based health center;Self Destructive Behavior;Series;Sexual abuse;Substance abuse problem;support tools;System;Technology;Testing;tool;Translating;Translations;traumatic stress;Universities;US State;Violence;Work

PROJECT_TITLE: The Center on Causal Data Science for Child Maltreatment Prevention (the CHAMP Center)


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Digestive Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Lung;Lung Cancer;Prevention;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health

PI_NAMEs: HULL, PAMELA CARMEN (contact)

PROJECT_TERMS: Acceleration;Address;Advocacy;Advocate;Appalachian Region;Award;Back;Black Populations;Cancer Burden;cancer care;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer health disparity;cancer site;Catchment Area;Cervical;Clinical;Clinical Trials;Collaborations;colon cancer screening;Colon Carcinoma;Colorectal;Communities;community engagement;Community Health Education;Community Outreach;Consultations;Data;Data Sources;Development;Disparity;Dissemination and Implementation;Education;Education and Outreach;Electronics;Environmental Exposure;Equity;ethnic disparity;evidence based guidelines;Evidence based practice;Feedback;Fostering;Funding;geographic disparity;Geography;Goals;Grant;Head and neck structure;health equity;Health Services Accessibility;Hepatitis C virus;Hispanic Populations;Hospitals;Human Papilloma Virus Vaccination;Human Papillomavirus;improved;Incidence;Individual;innovation;Investments;Kentucky;Leadership;Lung;lung cancer screening;Malignant Neoplasms;meetings;Melanoma;member;Monitor;mortality;NCI Center for Cancer Research;Needs Assessment;Obesity;Outcome;outreach program;Patient Education;Patients;Persons;Policies;Population;Poverty;Preventive service;Printing;Process;Professional Practice;programs;Quality Indicator;Race;racial disparity;Recording of previous events;Reporting;Research;Research Personnel;Research Priority;Risk Factors;Rural;Screening for cancer;screening program;Shapes;Smoking;social media;socioeconomics;Therapeutic Trials;Tobacco;Training;Training Activity;Underrepresented Minority;Universities;Virus;Visit;volunteer

PROJECT_TITLE: Community Outreach and Engagement


NIH_SPENDING_CATS: Child Abuse and Neglect Research;Childhood Injury;Data Science;Pediatric;Prevention;Social Determinants of Health;Violence Research

PROJECT_TERMS: Adolescent;Advisory Committees;Budgets;Child;Child Abuse and Neglect;Clinical;Collaborations;Communication;Community Services;Coordination and Collaboration;Data Science;Ensure;Funding;Goals;Human Resources;improved;Individual;Knowledge;maltreatment;meetings;Mission;Monitor;novel strategies;operation;Outcome;Participant;Persons;Play;prevent;Prevention;Process;Productivity;Program Evaluation;Research;Research Project Grants;Role;Services;Social Work;System;tool;Translating;traumatic stress;Work

PROJECT_TITLE: Administrative Core


NIH_SPENDING_CATS: Bioengineering;Child Abuse and Neglect Research;Childhood Injury;Cost Effectiveness Research;Data Science;Networking and Information Technology R&D (NITRD);Pediatric;Prevention;Social Determinants of Health;Violence Research

PI_NAMEs: KUMMERFELD, ERICH  (contact)

PROJECT_TERMS: Adolescent;Algorithms;Architecture;Area;Categories;causal model;Child;Child Abuse and Neglect;Clinical;complex modeling;computer infrastructure;Computer software;Cost Effectiveness Analysis;Data;Data Analyses;data management;data quality;Data Science;data tools;data warehouse;Development;Doctor of Philosophy;Education;Educational Curriculum;Elements;Ensure;Environment;Evaluation;experience;field study;Foundations;High Performance Computing;improved;Information Technology;Infrastructure;insight;Intervention;Knowledge;Knowledge Discovery;Maintenance;maltreatment;Manuals;Minnesota;Mission;model building;Modeling;Monitor;operation;Outcome;outreach;Play;Positioning Attribute;Predictive Factor;predictive modeling;Preparation;prevent;Prevention;Public Health Informatics;Recommendation;Research;Research Design;Resources;Risk;Role;Safety;Scientist;Secure;Services;software development;Software Tools;Solid;success;support tools;Technical Expertise;Testing;theories;tool;Training;Translating;Translational Research;Translations;Universities;Validation;Work

PROJECT_TITLE: Resource Core


NIH_SPENDING_CATS: Biotechnology;Cancer;Childhood Leukemia;Clinical Research;Hematology;Immunotherapy;Orphan Drug;Pediatric;Pediatric Cancer;Rare Diseases;Transplantation

ORG_CITY: ATLANTA

ORG_NAME: CAMBIUM ONCOLOGY LLC

ORG_STATE: GA

PHR: Narrative Acute myeloid leukemia (AML) is a common hematological malignancy in adults with a poor 5-year survival rate (29.5%). Immunotherapies that help a patient’s immune system fight the cancer are an attractive therapeutic approach for AML. Cambium Oncology has recently reported that daily treatment with an innovative drug called ANT308, improves immune responses in animal models of cancer. During this project the company will advance a long-acting form of its lead drug and do studies needed to prepare an application to the FDA to get approval to test the new drug in a clinical trial to treat AML patients.

PI_NAMEs: ALTMAN, GARY G. (contact);WALLER, EDMUND K

PROGRAM_OFFICER_NAME: REGMI, SAROJ GOPAL

PROJECT_TERMS: Acute Myelocytic Leukemia;acute myeloid leukemia cell;adaptive immunity;Address;Adult;Affinity;Allogeneic Bone Marrow Transplantation;Amino Acids;Animal Cancer Model;antagonist;anti-cancer;anti-PD-1;anti-PD-L1 antibodies;antileukemic activity;Antineoplastic Agents;Autologous;Binding;Biological Markers;Biotechnology;Blood;Bone Marrow Cells;Businesses;cancer cell;Cardiac;cell mediated immune response;checkpoint therapy;chemotherapy;clinical development;Clinical Trials;Cytomegalovirus;Cytomegalovirus Infections;cytotoxic;Data;Dendritic Cells;Development;Diagnosis;Doctor of Philosophy;Dose;drug candidate;drug development;Drug Kinetics;Elderly;Enteric Nervous System;exhaust;Exhibits;experience;Family suidae;fighting;Future;Generations;Goals;graft vs leukemia effect;Growth;Half-Life;Hematologic Neoplasms;Hematopoietic Neoplasms;High Dose Chemotherapy;Hour;Human;Immune Evasion;immune modulating agents;Immune response;Immune system;Immunoglobulin G;Immunotherapeutic agent;Immunotherapy;improved;in silico;In Vitro;in vivo;in vivo evaluation;innovation;Institution;Lead;lead candidate;Left;Legal patent;leukemia;leukemia treatment;Libraries;Licensing;Ligands;Malignant neoplasm of pancreas;Malignant Neoplasms;Measures;Messenger RNA;Modeling;Morbidity - disease rate;mortality;mouse model;Mus;novel;novel therapeutics;Oncology;Organ;overexpression;Patients;peptide vaccination;Peptides;Peripheral;Peristalsis;Pharmaceutical Preparations;Pharmacodynamics;Pharmacologic Substance;Phase;Phase I Clinical Trials;Physicians;Plasma;pre-clinical;pre-Investigational New Drug meeting;preclinical study;Proteins;Publishing;Rat-1;Rattus;Regulatory Pathway;Reporting;Research;Research Design;response;screening;Signal Transduction;Small Business Innovation Research Grant;stability testing;Survival Rate;T-Cell Activation;T-Lymphocyte;Testing;Therapeutic;Toxic effect;Toxicology;transplant model;Treatment outcome;tumor immunology;Universities;Up-Regulation;Vasoactive Intestinal Peptide;Vasoactive Intestinal Peptide Receptors;Vasodilation;VIPR1 gene;Work

PROJECT_TITLE: Development of a Novel Immunotherapeutic for Acute Myeloid Leukemia

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-V (13)]


NIH_SPENDING_CATS: Cancer;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Prevention

PI_NAMEs: ANTHONY, LOWELL B. (contact)

PROJECT_TERMS: Area;authority;Basic Science;Biometry;Cancer Burden;Cancer Center;Cancer Center Support Grant;cancer clinical trial;Cancer Control;Cancer Intervention;cancer prevention;cancer research center director;Catchment Area;Charge;Clinical Cancer Center;clinical care;Clinical Oncology;Clinical Protocols;Clinical Research;clinical translation;Clinical Trials;clinically relevant;Committee Members;Communication;community engagement;Conduct Clinical Trials;Data;Discipline;Disease;Education;Electronics;Ensure;Evaluation;expectation;Faculty;Funding;Goals;Guidelines;human subject;Individual;Industry;innovation;Institution;Institutional Review Boards;interest;Intervention;Intervention Studies;Kentucky;Laboratory Research;Malignant Neoplasms;member;mid-career faculty;Mission;Modification;Monitor;Observational Study;Outcome;Pathology;patient population;Patients;Peer Review;Performance;Pharmacology;Policies;Population Heterogeneity;Prevention;Process;professor;Protocols documentation;Radiology Specialty;Recommendation;Reporting;Research;Research Personnel;Resources;Review Committee;Safety;Scientific Advances and Accomplishments;Structure;success;System;Time;trial enrollment;Underserved Population;Universities;Vulnerable Populations

PROJECT_TITLE: Protocol Review and Monitoring System


NIH_SPENDING_CATS: Behavioral and Social Science;Child Abuse and Neglect Research;Childhood Injury;Data Science;Machine Learning and Artificial Intelligence;Mental Health;Pediatric;Physical Injury - Accidents and Adverse Effects;Precision Medicine;Prevention;Social Determinants of Health;Violence Research

PI_NAMEs: MA, SISI  (contact)

PROJECT_TERMS: Address;Administrator;Adolescent;Aggressive behavior;behavioral health;Categories;causal model;Characteristics;Child;Child Abuse and Neglect;Child Health;Child Welfare;Classification;Clinical;Clinical Decision Support Systems;clinical translation;Collaborations;Collection;Complex;Data Science;Data Set;Dedications;demographics;design;Disease;Doctor of Philosophy;Economics;Education;Ensure;Etiology;Family;Family member;Functional impairment;Genetic;Goals;Health;Impairment;improved;Individual;individualized prevention;Infrastructure;insight;Intervention;Knowledge;machine learning pipeline;machine learning prediction;maltreatment;medical schools;member;Mental Depression;Mental Health;Methods;Minnesota;model building;Modeling;multidisciplinary;neglect;Obesity;Outcome;outreach;pediatrician;Performance;personalized medicine;personalized risk prediction;physical abuse;physical conditioning;Population;Positioning Attribute;Post-Traumatic Stress Disorders;predictive modeling;prevent;Prevention;Primary Care;psychobiologic;Public Health Informatics;Recommendation;Recording of previous events;Research;Research Project Grants;Resources;Risk;Risk Factors;Risk Management;risk prediction;Risk Reduction;Scientist;Self-Injurious Behavior;Severities;Sexual abuse;Signal Transduction;social;Substance abuse problem;success;support tools;System;Testing;Time;tool;Translating;translational model;Translations;traumatic stress;trustworthiness;Universities;Work

PROJECT_TITLE: Research Project 1


PHR: Project Narrative Not applicable. This document is attached to satisfy electronic submission requirements.

PI_NAMEs: WEISS, HEIDI L (contact)

PROJECT_TERMS: Advisory Committees;Affect;anti-cancer research;Applications Grants;Assessment tool;Basic Science;Bioinformatics;biomarker driven;Biometry;Budgets;Businesses;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer genomics;cancer prevention;Cancer Prevention Intervention;cancer research center director;Cancer Therapy Evaluation Program;cellular oncology;Clinic;Clinical Research;Clinical Trials;Communication;Communities;community based research;Comprehensive Cancer Center;cost;cost effective;cost effectiveness;data sharing;Decision Making;Dedications;Dissemination and Implementation;Documentation;Electronics;Ensure;epidemiology study;Evaluation;Evidence based intervention;Exhibits;experience;Financial Support;Flow Cytometry;Fostering;Funding;Genomics;Goals;Growth;Health;Health Insurance Portability and Accountability Act;Human Resources;Immunologic Monitoring;implementation facilitation;Improve Access;improved;Income;Informatics;Infrastructure;innovation;Institution;instrumentation;Investigation;Investments;Kentucky;Laboratories;Lead;Leadership;Marketing;Measurement;member;Metabolism;Methodology;Mission;Modeling;Modification;Molecular;molecular oncology;Monitor;NCI Center for Cancer Research;Office Management;Oncology;oncology program;operation;Outcome;Oxidation-Reduction;Pathology;patient oriented;Peer Review Grants;Performance;Population Intervention;Population Sciences;Population Study;Process;Productivity;programs;Recommendation;Reporting;Research;Research Personnel;Resource Sharing;Resources;Role;Science;Screening for cancer;Secure;service coordination;Service provision;Services;Site Visit;skills;Strategic Planning;survivorship;System;targeted treatment;Technical Expertise;Technology;Therapeutic Trials;Tobacco;tool;Training;Training and Education;translational oncology;translational study;treatment program;Universities;Work

PROJECT_TITLE: Shared Resource Management


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Genetics;Human Genome;Immunotherapy;Orphan Drug;Rare Diseases;Urologic Diseases

ORG_CITY: RALEIGH

ORG_DEPT: ENGINEERING (ALL TYPES)

ORG_NAME: NORTH CAROLINA STATE UNIVERSITY RALEIGH

PHR: RELEVANCE TO PUBLIC HEALTH  Even with life-altering surgical removal of the bladder, roughly half of all patients with muscle-invasive bladder cancer die within five years of diagnosis. Numerous similarities between canine and human bladder cancers imply that novel treatments found to be successful in dogs are likely to be successful in people. This project will: 1) evaluate the effectiveness of a promising immunotherapy in pet dogs with spontaneous invasive bladder cancer, and 2) determine if canine bladder cancer is a useful model for testing other promising human bladder cancer immunotherapies.

PI_NAMEs: HESS, PAUL R;ZAHAROFF, DAVID  (contact)

PROGRAM_OFFICER_NAME: HU, ZHANG-ZHI

PROJECT_TERMS: Abscopal effect;Adverse effects;Adverse event;anti-tumor immune response;Antibodies;antigen-specific T cells;Antitumor Response;Appointment;Behavior;Biological Assay;Biomedical Engineering;Biopolymers;Bladder Neoplasm;bladder transitional cell carcinoma;cancer genetics;cancer immunotherapy;cancer infiltrating T cells;Cancer Patient;cancer subtypes;Canis familiaris;Cells;checkpoint therapy;Chitosan;Client;clinical examination;clinical translation;Clinical Trials;cohort;Collaborations;college;comparative;Correlative Study;Cystectomy;cytokine;Data;design;Diagnosis;Disease;Distant;Dose;Drug Kinetics;effective therapy;effectiveness evaluation;Enrollment;Environment;Evaluation;Evolution;Excision;exome sequencing;Exposure to;Flow Cytometry;Gene Expression;Genes;Heterogeneity;Histologic;Human;Immune;Immune checkpoint inhibitor;immune-related adverse events;Immunity;Immunobiology;Immunogenomics;Immunologics;Immunooncology;Immunophenotyping;Immunotherapy;immunotoxicity;Implant;In Vitro;Interleukin-12;Interleukin-12 therapy;intravesical;Intravesical Administration;Intravesical Instillation;Laboratories;Life;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Measures;Medical;Medical Oncologist;Medical Oncology;Modeling;molecular subtypes;Monitor;multidisciplinary;Mus;muscle invasive bladder cancer;Mutation;nano-string;neoantigens;Neoplasm Metastasis;novel;Oncology;Pathology;Patients;PD-1/PD-L1;Peripheral;Persons;Pharmacodynamics;Phase;Phenotype;Positioning Attribute;pre-clinical research;preclinical study;prevent;programs;Public Health;Recombinants;Recommendation;recruit;Refractory;Research Personnel;response;Rodent Model;Route;Safety;safety assessment;Serum;Site;T cell clonality;T cell receptor repertoire sequencing;T cell response;T-Lymphocyte;Testing;transcriptome;transcriptome sequencing;Transitional Cell Carcinoma;Translations;trial design;tumor;Tumor Immunity;Tumor Volume;tumor-immune system interactions;tumorigenesis;UNC Lineberger Comprehensive Cancer Center;uptake;Urology;Veterinary Medicine;Work

PROJECT_TITLE: Intravesical Immunotherapy of Spontaneous Canine Invasive Urothelial Carcinoma