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Prevalence of BRCA in Patients with primary platinum sensitive recurrent ovarian cancer

Conditions
C56
Malignant neoplasm of ovary
Registration Number
DRKS00006745
Lead Sponsor
AGO Research GmbH, AGO Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
530
Inclusion Criteria

1. Female ovarian cancer patients aged >= 18 years.
2. Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with platinum-sensitive recurrent ovarian cancer (i.e., women who have received an initial course of platinum-based chemotherapy and with no evidence of disease progression for at least 6 months after the last administration of a platinum-based regimen for initial treatment).
3. Multiple platinum based prior therapies are allowed.

Exclusion Criteria

1. Non-epithelial ovarian malignancy.
2. Platinum resistant or refractory disease.
3. Paraffin embedded tumor samples not available.

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evidence of germline alterations in BRCA1/2 and other ovarian cancer predisposing genes
Secondary Outcome Measures
NameTimeMethod
• Immunohistochemistry and DNA extraction from tumor samples • Evidence of somatic alterations in BRCA1/2 and other ovarian cancer predisposing genes • Evidence for a BRCAness tumor phenotype in ovarian cancer • Differences of tumor samples from primary and relapsed disease • Evaluation of patient perspectives and satisfaction regarding testing and counseling (survey)<br>
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