Breast Cancer Registry Platform

NCT ID: NCT03417115

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-22
• Study Completion Date: 2029-04-30

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Advanced breast cancer - Her2 positive

Patients with HER2-positive advanced breast cancer

No interventions assigned to this group

Advanced breast cancer - triple negative

Patients with triple negative advanced breast cancer

No interventions assigned to this group

Advanced breast cancer - HR positive, Her2 negative

Patients with HR positive, Her2 negative advanced breast cancer

No interventions assigned to this group

Early breast cancer - HER2 positive

Patients with HER2 positive early breast cancer

No interventions assigned to this group

Early breast cancer - triple negative

Patients with triple negative early breast cancer

No interventions assigned to this group

Early breast cancer - HR positive, HER2 negative

Patients with HR positive, HER2 negative early breast cancer

No interventions assigned to this group

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norbert Marschner, MD

Role: STUDY_CHAIR

Praxis für interdisziplinäre Onkologie & Hämatologie

Locations

Multiple sites all over germany

Many Locations, , Germany

Countries

Germany

References

Thill M, Zahn MO, Welt A, Stickeler E, Nusch A, Fietz T, Rauh J, Wetzel N, Kruggel L, Janicke M, Marschner N, Harbeck N, Wockel A, Decker T; OPAL study group. Treatment and outcome in metastatic lobular breast cancer in the prospective German research platform OPAL. Breast Cancer Res Treat. 2023 Apr;198(3):545-553. doi: 10.1007/s10549-023-06882-7. Epub 2023 Feb 18.

Reference Type: BACKGROUND

PMID: 36807725 (View on PubMed)

Other Identifiers

Registerplattform OPAL

Identifier Type: OTHER

Identifier Source: secondary_id

IOM-100361

Identifier Type: -

Identifier Source: org_study_id