NCT03417115

Breast Cancer Registry Platform

Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: iOMEDICO AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.

Detailed description

OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life in patients with breast cancer will be evaluated for up to five years.

Conditions

• Breast Cancer

Timeline

• Start date: 2017-12-22
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2018-01-31
• Last updated: 2025-08-28

Locations

1 site across 1 country: Germany