Advanced Breast Cancer Registry Platform (OPAL)
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|ClinicalTrials.gov Identifier: NCT03417115|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : August 6, 2019
|Condition or disease|
|Advanced Breast Cancer|
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]|
|Estimated Enrollment :||2000 participants|
|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|
Patients with Her2 positive tumors
Patients with triple negative tumors
HR positive, Her2 negative
Patients with HR positive, Her2 negative tumors
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417115
|Contact: Lisa Kruggel||+49 761 email@example.com|
|Contact: Natalie Wetzel||+49 761 firstname.lastname@example.org|
|Multiple sites all over germany||Recruiting|
|Multiple Locations, Germany|
|Contact: iOMEDICO AG +49 761 15242-0 email@example.com|
|Study Chair:||Norbert Marschner, MD||Praxis für interdisziplinäre Onkologie & Hämatologie|