Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients
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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.
KeywordsBreast cancer BRCA1 BRCA2 PARP inhibitors Talazoparib Clinical trial eligibility
The PRAEGNANT network is supported by grants from Novartis and Pfizer. We thank BioMarin Pharmaceutical Inc. for valuable cooperation. The study was supported in part by the German Federal Ministry of Economic Affairs and Energy through the ″Clinical Data Intelligence″ grant (01MT14001E).
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- 2.Fasching PA, Ekici AB, Wachter DL, Hein A, Bayer CM, Haberle L, Loehberg CR, Schneider M, Jud SM, Heusinger K, Rubner M, Rauh C, Bani MR, Lux MP, Schulz-Wendtland R, Hartmann A, Beckmann MW (2013) Breast cancer risk—from genetics to molecular understanding of pathogenesis. Geburtshilfe Frauenheilkd 73(12):1228–1235. doi: 10.1055/s-0033-1360178 CrossRefPubMedPubMedCentralGoogle Scholar
- 3.von Minckwitz G, Loibl S, Schneeweiss A, Salat CT, Rezai M, Zahm DM, Klare P, Blohmer JU, Tesch H, Khandan F, Fasching PA, Jakisch C, Nekljudova V, Untch M (2015) Early survival analysis of the randomized phase II trial investigating the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive early breast cancer (GeparSixto) Cancer Res 76(4 Suppl):Abstract nr S2-04. (76(4 Suppl)):Abstract nr S2-04Google Scholar
- 4.ClinicalTrials.gov (2016) Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA). https://clinicaltrials.gov/ct2/show/NCT02032823 Accessed on 10 Mar 2016
- 5.ClinicalTrials.gov (2016) A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA). https://clinicaltrials.gov/ct2/show/NCT01945775 Accessed on 10 Mar 2016
- 6.Fasching PA, Brucker SY, Fehm TN, Overkamp F, Janni W, Wallwiener M, Hadji P, Belleville E, Haberle L, Taran FA, Luftner D, Lux MP, Ettl J, Muller V, Tesch H, Wallwiener D, Schneeweiss A (2015) Biomarkers in patients with metastatic breast cancer and the PRAEGNANT study network. Geburtshilfe Frauenheilkd 75(1):41–50. doi: 10.1055/s-0034-1396215 CrossRefPubMedPubMedCentralGoogle Scholar
- 13.ClinicalTrials.gov (2015, accessed Dec 14, 2015) A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study). https://clinicaltrials.gov/ct2/show/NCT01945775
- 15.Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A, Grant A, group S (2007) Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health technology assessment 11 (48):iii, ix-105Google Scholar
- 19.Wallwiener M, Wallwiener CW, Brucker SY, Hartkopf AD, Fehm TN, Kansy JK (2010) The brustkrebs-studien.de website for breast cancer patients: user acceptance of a German internet portal offering information on the disease and treatment options, and a clinical trials matching service. BMC Cancer 10:663. doi: 10.1186/1471-2407-10-663 CrossRefPubMedPubMedCentralGoogle Scholar
- 20.Embi PJ, Jain A, Clark J, Harris CM (2005) Development of an electronic health record-based Clinical Trial Alert system to enhance recruitment at the point of care. AMIA Annual Symposium proceedings/AMIA Symposium AMIA Symposium:231-235Google Scholar