Prognostic and Predictive Biomarkers in Ovarian Cancers

NCT ID: NCT03010124

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-26
• Study Completion Date: 2032-09-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with ovarian cancer

Group Type: OTHER

Blood sample

Intervention Type: PROCEDURE

Interventions

Blood sample

Intervention Type: PROCEDURE

Eligibility Criteria

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

2. Coagulation abnormalities that contra-indicates the biopsy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, Val De Marne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Alexandra LEARY, MD

Role: CONTACT

alexandra.leary@gustaveroussy.fr

+33 (0)1 42 11 43 89

Damien DRUBAY

Role: CONTACT

damien.drubay@gustaveroussy.fr

+33 (0)1 42 11 42 11

Facility Contacts

Alexandra LEARY, MD

Role: primary

alexandra.leary@gustaveroussy.fr

+33 (0)1 42 11 43 89

Damien DRUBAY

Role: backup

damien.drubay@gustaveroussy.fr

+33 (0)1 42 11 42 11

Other Identifiers

2015/2290

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A01183-46

Identifier Type: -

Identifier Source: org_study_id