Prevalence of BRCA in Patients With Ovarian Cancer
Completed
- Conditions
- Ovarian CancerBRCA Status
- Registration Number
- NCT02222883
- Lead Sponsor
- AGO Research GmbH
- Brief Summary
The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.
- Detailed Description
Explorative analysis will be performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 530
Inclusion Criteria
- Female ovarian cancer patients aged >= 18 years.
- Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with platinum-sensitive recurrent ovarian cancer.
- Multiple platinum based prior therapies are allowed.
Exclusion Criteria
- Non-epithelial ovarian malignancy.
- Platinum-resistant or refractory disease.
- Paraffin embedded tumor samples not available.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) once per sample
- Secondary Outcome Measures
Name Time Method Results of Immunohistochemistry in tumor samples once per sample Patient Survey for perspectives and satisfaction regarding testing and counseling once after BRCA result is available 3 questions
Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies once Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) once per sample BRCAness tumor phenotype in ovarian cancer (yes/no). once per sample Differences of tumor samples from primary and relapsed disease once per sample for each stage of disease
Trial Locations
- Locations (19)
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinik Carl Gustav Carus
🇩🇪Dresden, Germany
Evangelisches Krankenhaus
🇩🇪Düsseldorf, Germany
Kliniken Essen-Mitte
🇩🇪Essen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt/Main, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
NCT Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Scroll for more (9 remaining)Charité - Universitätsmedizin Berlin🇩🇪Berlin, Germany