Prognostic and Predictive Biomarkers in Ovarian Cancers

Not Applicable

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT03010124
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-26
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2017-01-02
• Study First Posted: 2017-01-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2030-09
• Study Completion: 2032-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

1. New patient with a diagnosis of OC, or
2. 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
3. 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.
4. Signed informed consent
5. Age ≥ 18
6. Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria

1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
2. Coagulation abnormalities that contra-indicates the biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion	up to 12 months

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France