Ovarian Cancer
Conditions
Keywords
PARP Inhibitors, immunomonitoring
Brief summary
This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.
Detailed description
The aim is to assess the impact of anti-PARP on peripheral immune populations and the amount of DNA circulating; to correlate these data with tumor infiltration, with the initial clinical characteristics and with the clinical course; compare the immunogenic effect of different anti-PARPs.
Interventions
BIOLOGICALblood samples
Blood sampling during PARP inhibitor therapy
Sponsors
Centre Georges Francois Leclerc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient over 18 years 2. Patient treated for epithelial ovarian cancer 3. Eligible for anti-PARP therapy and in one of the 2 cohorts below: * Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy. * 2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy. 4. Patient having signed the informed consent form. 5. Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up. 6. Patient affiliated to the social security system.
Exclusion criteria
1. Non-epithelial tumour of the ovary 2. Patient unable to understand, read and/or sign informed consent. 3. Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions. 4. Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included. 5. Pregnant or breast-feeding women. 6. HIV and/or HBV and/or HCV serology positive. 7. Patient refusal. 8. Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice). 9. Inability to undergo medical follow-up for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response in plasma | From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months | Realization of a plasma library |
| Immune response in PBMC | From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months | Realization of a PBMC bank |
| Immune response in tumor DNA | From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months | Realization of a circulating tumor DNA bank |
Countries
France
Outcome results
None listed