Breast Cancer Registry Platform

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT03417115
• Lead Sponsor: iOMEDICO AG

Brief 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.

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

EBC cohort:

• Female and male patients with early breast cancer (stage I-III defined as breast cancer that has not spread beyond the breast or the axillary lymph nodes)
• Patients at the start of their initial systemic treatment for EBC, i.e. at start of neoadjuvant treatment for patients receiving neoadjuvant thera-py or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, what-ever was given first

ABC cohort:

• Female and male patients with advanced breast cancer (stage IV defined as synchronous or metachronous diagnosis of distant metastases at inclusion)
• Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first

All cohorts:

• Written informed consent

  • Patients participating in the PRO module: signing of informed consent form and completion of baseline questionnaire before start of initial systemic treatment for EBC or systemic first-line treatment for ABC
  • Patients not participating in the PRO module: within six weeks after start of initial systemic treatment for EBC or systemic first-line treatment for ABC

• Age ≥ 18 years

Read More

Exclusion Criteria

• Patients with prior systemic therapy (cytotoxic, endocrine, or targeted) for EBC or ABC
• Patients who do not receive any systemic therapy for EBC or ABC

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment reality	5 years	Description of treatment reality (Course of systemic treatments and sequential treatments) applied in German routine practice measured as the frequency of the various systemic treatments applied per line of therapy.

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	5 years	Documentation of disease-free survival.
Health-related quality of life (Patient-reported outcome)	3.5 years	EORTC QLQ-C30 core questionnaire and additional items.
Best Response	5 years	Documentation of response rates per line of treatment.
Progression-free survival	5 years	Documentation of progression-free survival per line of treatment.
Overall survival	5 years	Documentation of date of death.

Trial Locations

Locations (1)

Multiple sites all over germany; 🇩🇪 Multiple Locations, Germany