Status:
UNKNOWN
Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
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 characterist...
Eligibility Criteria
Inclusion
- Patient over 18 years
- Patient treated for epithelial ovarian cancer
- 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.
- Patient having signed the informed consent form.
- Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.
- Patient affiliated to the social security system.
Exclusion
- Non-epithelial tumour of the ovary
- Patient unable to understand, read and/or sign informed consent.
- 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.
- Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.
- Pregnant or breast-feeding women.
- HIV and/or HBV and/or HCV serology positive.
- Patient refusal.
- Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).
- Inability to undergo medical follow-up for geographical, social or psychological reasons.
Key Trial Info
Start Date :
July 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 10 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04675320
Start Date
July 7 2020
End Date
November 10 2024
Last Update
December 7 2023
Active Locations (2)
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1
CHRU Jean Minjoz
Besançon, France, 25000
2
Centre Georges Francois Leclerc
Dijon, France, 21000