Breast Cancer Registry Platform (OPAL)

March 8, 2024 updated by: iOMEDICO AG

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Recruiting
        • Multiple sites all over germany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Advanced breast cancer - Her2 positive
Patients with HER2-positive advanced breast cancer
Advanced breast cancer - triple negative
Patients with triple negative advanced breast cancer
Advanced breast cancer - HR positive, Her2 negative
Patients with HR positive, Her2 negative advanced breast cancer
Early breast cancer - HER2 positive
Patients with HER2 positive early breast cancer
Early breast cancer - triple negative
Patients with triple negative early breast cancer
Early breast cancer - HR positive, HER2 negative
Patients with HR positive, HER2 negative early breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment reality
Time Frame: 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.
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Norbert Marschner, MD, Praxis für interdisziplinäre Onkologie & Hämatologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-100361
  • Registerplattform OPAL (Other Identifier: iOMEDICO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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