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Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors | Clinical Trials | Clareo Health

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Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors

NCT04675320•Centre Georges Francois Leclerc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (2)

CHRU Jean Minjoz

Besançon, France

Centre Georges Francois Leclerc

Dijon, France

Key Dates

Start Date

July 7, 2020

Primary Completion Date

November 10, 2022

Completion Date

November 10, 2024

Last Updated

December 7, 2023

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

blood samples

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors

Inclusion Criteria

Exclusion Criteria

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