Prognostic and Predictive Biomarkers in Ovarian Cancers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •New patient with a diagnosis of OC, or
- •Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
- •Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
- •Signed informed consent
- •Patient affiliated to a social security regimen or beneficiary of the same
Exclusion Criteria
- •Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
- •Coagulation abnormalities that contra-indicates the biopsy
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion
up to 12 months