title: Definitive Characterization of CA 19-9 in Resectable Pancreatic Cancer Using a Reference Set of Serum and Plasma Specimens.
abstract: The validation of candidate biomarkers often is hampered by the lack of a reliable means of assessing and comparing performance. We present here a reference set of serum and plasma samples to facilitate the validation of biomarkers for resectable pancreatic cancer. The reference set includes a large cohort of stage I-II pancreatic cancer patients, recruited from 5 different institutions, and relevant control groups. We characterized the performance of the current best serological biomarker for pancreatic cancer, CA 19-9, using plasma samples from the reference set to provide a benchmark for future biomarker studies and to further our knowledge of CA 19-9 in early-stage pancreatic cancer and the control groups. CA 19-9 distinguished pancreatic cancers from the healthy and chronic pancreatitis groups with an average sensitivity and specificity of 70-74%, similar to previous studies using all stages of pancreatic cancer. Chronic pancreatitis patients did not show CA 19-9 elevations, but patients with benign biliary obstruction had elevations nearly as high as the cancer patients. We gained additional information about the biomarker by comparing two distinct assays. The two CA 9-9 assays agreed well in overall performance but diverged in measurements of individual samples, potentially due to subtle differences in antibody specificity as revealed by glycan array analysis. Thus, the reference set promises be a valuable resource for biomarker validation and comparison, and the CA 19-9 data presented here will be useful for benchmarking and for exploring relationships to CA 19-9.
authors.affiliation: Van Andel Research Institute, Grand Rapids, MI, United States of America.
authors.forename: Brian B
authors.initials: BB
authors.lastname: Haab
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
authors.forename: Ying
authors.initials: Y
authors.lastname: Huang
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.
authors.forename: Seetharaman
authors.initials: S
authors.lastname: Balasenthil
authors.affiliation: Van Andel Research Institute, Grand Rapids, MI, United States of America.
authors.forename: Katie
authors.initials: K
authors.lastname: Partyka
authors.affiliation: Van Andel Research Institute, Grand Rapids, MI, United States of America.
authors.forename: Huiyuan
authors.initials: H
authors.lastname: Tang
authors.affiliation: University of Michigan, Ann Arbor, MI, United States of America.
authors.forename: Michelle
authors.initials: M
authors.lastname: Anderson
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY, United States of America.
authors.forename: Peter
authors.initials: P
authors.lastname: Allen
authors.affiliation: University of Nebraska Medical Center, Omaha, NE, United States of America.
authors.forename: Aaron
authors.initials: A
authors.lastname: Sasson
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, PA, United States of America.
authors.forename: Herbert
authors.initials: H
authors.lastname: Zeh
authors.affiliation: Northshore University Healthsystems, Evanston, IL, United States of America.
authors.forename: Karen
authors.initials: K
authors.lastname: Kaul
authors.affiliation: Palo Alto Research Center, Palo Alto, CA, United States of America.
authors.forename: Doron
authors.initials: D
authors.lastname: Kletter
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
authors.forename: Shaokui
authors.initials: S
authors.lastname: Ge
authors.affiliation: Palo Alto Research Center, Palo Alto, CA, United States of America.
authors.forename: Marshall
authors.initials: M
authors.lastname: Bern
authors.affiliation: University of Michigan, Ann Arbor, MI, United States of America.
authors.forename: Richard
authors.initials: R
authors.lastname: Kwon
authors.affiliation: University Health Network, Toronto, ON, Canada.
authors.forename: Ivan
authors.initials: I
authors.lastname: Blasutig
authors.affiliation: National Cancer Institute, Rockville, MD, United States of America.
authors.forename: Sudhir
authors.initials: S
authors.lastname: Srivastava
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.
authors.forename: Marsha L
authors.initials: ML
authors.lastname: Frazier
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.
authors.forename: Subrata
authors.initials: S
authors.lastname: Sen
authors.affiliation: University of Nebraska Medical Center, Omaha, NE, United States of America.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Hollingsworth
authors.affiliation: National Cancer Institute, Rockville, MD, United States of America.
authors.forename: Jo Ann
authors.initials: JA
authors.lastname: Rinaudo
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.
authors.forename: Ann M
authors.initials: AM
authors.lastname: Killary
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, PA, United States of America.
authors.forename: Randall E
authors.initials: RE
authors.lastname: Brand
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood; D018395:CA-19-9 Antigen / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000097:blood*; D050500:Pancreatitis, Chronic / Q000097:blood; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen