Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients.
As breast cancer is a diverse disease, clinical trials are becoming increasingly diversified and are consequently being conducted in very small subgroups of patients, making study recruitment increasingly difficult. The aim of this study was to assess the use of data from a remote data entry system that serves a large national registry for metastatic breast cancer. The PRAEGNANT network is a real-time registry with an integrated biomaterials bank that was designed as a scientific study and as a means of identifying patients who are eligible for clinical trials, based on clinical and molecular information. Here, we report on the automated use of the clinical data documented to identify patients for a clinical trial (EMBRACA) for patients with metastatic breast cancer. The patients' charts were assessed by two independent physicians involved in the clinical trial and also by a computer program that tested patients for eligibility using a structured query language script. In all, 326 patients from two study sites in the PRAEGNANT network were included in the analysis. Using expert assessment, 120 of the 326 patients (37 %) appeared to be eligible for inclusion in the EMBRACA study; with the computer algorithm assessment, a total of 129 appeared to be eligible. The sensitivity of the computer algorithm was 0.87 and its specificity was 0.88. Using computer-based identification of patients for clinical trials appears feasible. With the instrument's high specificity, its application in a large cohort of patients appears to be feasible, and the workload for reassessing the patients is limited.
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander, Erlangen University Hospital University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.
Alexander
A
Hein
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander, Erlangen University Hospital University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.
Paul
P
Gass
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Christina Barbara
CB
Walter
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Florin-Andrei
FA
Taran
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Andreas
A
Hartkopf
Outpatient Department of Hematology and Oncology, Recklinghausen, Germany.
Friedrich
F
Overkamp
Marienhospital Bottrop, Bottrop, Germany.
Hans-Christian
HC
Kolberg
Nordwest Hospital, Frankfurt, Germany.
Peyman
P
Hadji
Onkologie Bethanien, Frankfurt, Germany.
Hans
H
Tesch
Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany.
Johannes
J
Ettl
Department of Gynecology and Obstetrics and Comprehensive Cancer Center, Ludwig Maximilian University, Munich, Germany.
Rachel
R
Wuerstlein
BioMarin Pharmaceutical Inc, San Rafael, CA, USA.
Debra
D
Lounsbury
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander, Erlangen University Hospital University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.
Michael P
MP
Lux
Department of Hematology, Oncology and Tumour ImmunologyCharité, University Hospital, Campus Benjamin Franklin, Berlin, Germany.
Diana
D
Lüftner
Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany.
Markus
M
Wallwiener
Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany.
Volkmar
V
Müller
Clin-Sol Ltd, Würzburg, Germany.
Erik
E
Belleville
Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Wolfgang
W
Janni
Department of Gynecology and Obstetrics, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
Tanja N
TN
Fehm
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Diethelm
D
Wallwiener
Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
Thomas
T
Ganslandt
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander, Erlangen University Hospital University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.|Institut Fuer Frauengesundheit GmbH, Erlangen, Germany.
Matthias
M
Ruebner
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander, Erlangen University Hospital University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.
Matthias W
MW
Beckmann
National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.
Andreas
A
Schneeweiss
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander, Erlangen University Hospital University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany. peter.fasching@uk-erlangen.de.
Peter A
PA
Fasching
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Sara Y
SY
Brucker
D000465:Algorithms; D001943:Breast Neoplasms / Q000628:therapy*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D018579:Patient Selection; D012042:Registries
BRCA1; BRCA2; Breast cancer; Clinical trial eligibility; PARP inhibitors; Talazoparib