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Breast Cancer Registry Platform (OPAL)

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ClinicalTrials.gov Identifier: NCT03417115
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

Study Description
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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 advanced breast cancer in Germany.

Condition or disease
Breast Cancer

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 advanced 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-realted quality of life in patients with advanced breast cancer will be evaluated for up to five years.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : April 2029
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Best Response [ Time Frame: 5 years ]
    Documentation of response rates per line of treatment.

  2. Progression-free survival [ Time Frame: 5 years ]
    Documentation of progression-free survival per line of treatment.

  3. Overall survival [ Time Frame: 5 years ]
    Documentation of date of death.

  4. Health-related quality of life (Patient-reported outcome) [ Time Frame: 3.5 years ]
    EORTC QLQ-C30 core questionnaire and additional items.

  5. Disease-free survival [ Time Frame: 5 years ]
    Documentation of disease-free survival.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 de-fined 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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417115


Contacts
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Contact: Lisa Kruggel +49 761 15242-0 info@iomedico.com
Contact: Anna Hof +49 761 15242-0 info@iomedico.com

Locations
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Germany
Multiple sites all over germany Recruiting
Multiple Locations, Germany
Contact: iOMEDICO AG    +49 761 15242-0    info@iomedico.com   
Sponsors and Collaborators
iOMEDICO AG
Investigators
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Study Chair: Norbert Marschner, MD Praxis für interdisziplinäre Onkologie & Hämatologie
More Information
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Additional Information:

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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT03417115    
Other Study ID Numbers: IOM-100361
Registerplattform OPAL ( Other Identifier: iOMEDICO )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
Breast Cancer
Epidemiology
Registry
Health Services Research
 Germany
Palliative Treatment
Adjuvant Treatment
Neoadjuvant Treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases