Breast Cancer Registry Platform (OPAL)

  • STATUS
    Recruiting
  • End date
    Apr 10, 2029
  • participants needed
    5000
  • sponsor
    iOMEDICO AG
Updated on 10 May 2022
advanced breast cancer

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.

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.

Details
Condition Breast Cancer
Clinical Study IdentifierNCT03417115
SponsoriOMEDICO AG
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
Written informed consent
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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