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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

Tracking Information
First Submitted Date January 24, 2018
First Posted Date January 31, 2018
Last Update Posted Date May 10, 2021
Actual Study Start Date December 22, 2017
Estimated Primary Completion Date April 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2021)
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.
Original Primary Outcome Measures
 (submitted: January 30, 2018)
Treatment reality [ Time Frame: 5 years ]
Course of systemic treatments and sequential treatments applied in German routine practice.
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2021)
  • Best Response [ Time Frame: 5 years ]
    Documentation of response rates per line of treatment.
  • Progression-free survival [ Time Frame: 5 years ]
    Documentation of progression-free survival per line of treatment.
  • Overall survival [ Time Frame: 5 years ]
    Documentation of date of death.
  • Health-related quality of life (Patient-reported outcome) [ Time Frame: 3.5 years ]
    EORTC QLQ-C30 core questionnaire and additional items.
  • Disease-free survival [ Time Frame: 5 years ]
    Documentation of disease-free survival.
Original Secondary Outcome Measures
 (submitted: January 30, 2018)
  • Best Response [ Time Frame: 5 years ]
    Documentation of response rates per line of treatment.
  • Progression-free survival [ Time Frame: 5 years ]
    Documentation of progression-free survival per line of treatment.
  • Overall survival [ Time Frame: 5 years ]
    Documentation of date of death.
  • Health-related quality of life (Patient-reported outcome) [ Time Frame: 3.5 years ]
    EORTC QLQ-C30 core questionnaire and additional items.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breast Cancer Registry Platform
Official Title Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 5, 2021)
5000
Original Estimated Enrollment
 (submitted: January 30, 2018)
2000
Estimated Study Completion Date April 2029
Estimated Primary Completion Date April 2029   (Final data collection date for primary outcome measure)
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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lisa Kruggel +49 761 15242-0 info@iomedico.com
Contact: Anna Hof +49 761 15242-0 info@iomedico.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03417115
Other Study ID Numbers IOM-100361
Registerplattform OPAL ( Other Identifier: iOMEDICO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party iOMEDICO AG
Study Sponsor iOMEDICO AG
Collaborators Not Provided
Investigators
Study Chair: Norbert Marschner, MD Praxis für interdisziplinäre Onkologie & Hämatologie
PRS Account iOMEDICO AG
Verification Date May 2021