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Breast Cancer Registry Platform

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03417115
Acronym
OPAL
Enrollment
6150
Registered
2018-01-31
Start date
2017-12-22
Completion date
2032-06-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Treatment, Neoadjuvant Treatment

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.

Interventions

None listed

Sponsors

iOMEDICO AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 therapy or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, whatever was given first ABC cohort I (prospective): * Female and male patients with advanced breast cancer (stage IV defined as synchrone or metachrone 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 ABC cohort II (retrospective): * Confirmed diagnosis of HR-positive, HER2-negative ABC (stage IV defined as synchrone or metachrone diagnosis of distant metastases at inclusion) * Start of initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first, between September 2021 and December 2025 * Inclusion is possible regardless of whether patients are alive or deceased at the time of documentation; for patients alive: written informed consent Prospective 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 * All 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 All cohorts: • Age ≥ 18 years

Design outcomes

Primary

MeasureTime frameDescription
Treatment reality5 yearsDescription 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

MeasureTime frameDescription
Best Response5 yearsDocumentation of response rates per line of treatment.
Progression-free survival5 yearsDocumentation of progression-free survival per line of treatment.
Overall survival5 yearsDocumentation of date of death.
Health-related quality of life (Patient-reported outcome)3.5 yearsEORTC QLQ-C30 core questionnaire and additional items.
Disease-free survival5 yearsDocumentation of disease-free survival.

Countries

Germany

Contacts

CONTACTLisa Kruggel
info@iomedico.com+49 761 15242-0
CONTACTUrsula Dietrich
info@iomedico.com+49 761 15242-0
STUDY_CHAIRNorbert Marschner, MD

Praxis für interdisziplinäre Onkologie & Hämatologie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026