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Advanced Breast Cancer Registry Platform (OPAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417115
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

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
Advanced 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Treatment and Outcome of Patients With Advanced Breast Cancer: Clinical Research Platform for Real World Data
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Her2 positive
Patients with Her2 positive tumors
triple negative
Patients with triple negative tumors
HR positive, Her2 negative
Patients with HR positive, Her2 negative tumors



Primary Outcome Measures :
  1. Treatment reality [ Time Frame: 5 years ]
    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.



Information from the National Library of Medicine

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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 advanced breast cancer (ABC) start-ing systemic treatment.
Criteria

Inclusion Criteria:

  • Female and male patients with advanced breast cancer (synchrone or metachrone metastasized or locally advanced, inoperable)
  • Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, what ever is given first
  • 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
  • Patients not participating in the PRO module: within six weeks after start of systemic first-line for ABC
  • Age ≥ 18 years
  • Patients participating in the PRO module: Sufficient knowledge of the German language to fill-in the questionnaires

Exclusion Criteria:

  • Patients with prior systemic therapy for ABC
  • Patient who do not receive any systemic therapy for ABC
  • Patients without ABC

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: Natalie Wetzel +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
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: August 6, 2019
Last Verified: August 2019
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases