Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients

Abstract

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.

Filtration based assessment of CTCs and CellSearch® based assessment are both powerful predictors of prognosis for metastatic breast cancer patients

“…Data was documented in an electronic case report form specialized on the documentation of MBC by trained and dedicated staff. The database had the same structure like the PRAEGNANT study [ 16 , 17 ] and data are monitored using automated plausibility checks. The documented data comprised information about primary diagnosis, surgery, treatment as well as progression and information about death.…”

TILGen: A Program to Investigate Immune Targets in Breast Cancer Patients - First Results on the Influence of Tumor-Infiltrating Lymphocytes

“…A web-based database was used for documentation as previously described [31,32]. Accordingly, each breast cancer case is prospectively documented, including patient and tumor characteristics, detailed treatment data, and epidemiological data.…”

Update Mammakarzinom 2019 Teil 2 – Implementierung neuer Diagnostika und Therapien bei Patientinnen mit fortgeschrittenem Brustkrebs in der klinischen Praxis

“…computerunterstützte Verwaltung. Der Support des Arztes durch Systeme, die möglicherweise durch maschinelles Lernen unterstützt werden, könnte ein Ansatz sein, diese Big-Data-Analysen in die klinische Praxis einzuführen [103,104].…”