Prevalence of BRCA in Patients With Ovarian Cancer

Completed

• Conditions: Ovarian Cancer; BRCA Status
• Interventions: Genetic: Testing of BRCA status regarding germline and somatic mutation

• 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.

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-21
• Study Start: 2015-03
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-11
• Last Update Posted: 2021-06-16

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

Arm && Interventions

Group	Intervention	Description
patients with platinum-sensitive recurrence	Testing of BRCA status regarding germline and somatic mutation	patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
patients with primary diagnosis	Testing of BRCA status regarding germline and somatic mutation	patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation

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)

Universitätsklinik Carl Gustav Carus; 🇩🇪 Dresden, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Evangelisches Krankenhaus; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Kliniken Essen-Mitte; 🇩🇪 Essen, Germany

Sana Klinikum Offenbach; 🇩🇪 Offenbach, Germany

Zentrum für Gynäkologische Onkologie; 🇩🇪 Kiel, Germany

Universitätsklinikum Gießen und Marburg; 🇩🇪 Marburg, Germany

NCT Heidelberg; 🇩🇪 Heidelberg, Germany

LMU München, Klinik Großhadern; 🇩🇪 München, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt/Main, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Klinikum rechts der Isar; 🇩🇪 München, Germany

Dr. Horst Schmidt Kliniken; 🇩🇪 Wiesbaden, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Universitäts-Frauenklinik; 🇩🇪 Tübingen, Germany