Overview

This trial is active, not recruiting.

Conditions brca status, ovarian cancer
Treatment testing of brca status regarding germline and somatic mutation
Sponsor AGO Research GmbH
Start date March 2015
End date September 2020
Trial size 530 participants
Trial identifier NCT02222883, AGO-TR 1

Summary

The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
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
testing of brca status regarding germline and somatic mutation

Primary Outcomes

Measure
Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
time frame: once per sample

Secondary Outcomes

Measure
Results of Immunohistochemistry in tumor samples
time frame: once per sample
Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
time frame: once per sample
BRCAness tumor phenotype in ovarian cancer (yes/no).
time frame: once per sample
Differences of tumor samples from primary and relapsed disease
time frame: once per sample for each stage of disease
Patient Survey for perspectives and satisfaction regarding testing and counseling
time frame: once after BRCA result is available
Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies
time frame: once

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.
Description Explorative analysis will be performed.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by AGO Research GmbH.