Status:
ACTIVE_NOT_RECRUITING
Breast Cancer Registry Platform
Lead Sponsor:
iOMEDICO AG
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
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 characteristi...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT03417115
Start Date
December 22 2017
End Date
April 1 2029
Last Update
August 28 2025
Active Locations (1)
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1
Multiple sites all over germany
Many Locations, Germany