Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
NCT ID: NCT04675320
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2020-07-07
2024-11-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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First-line epithelial ovarian cancer (30 patients)
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.
blood samples
Blood sampling during PARP inhibitor therapy
Recurrent epithelial ovarian cancer (20 patients)
Single-agent maintenance treatment of adult patients with primary, recurrent, platinum-sensitive epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.
blood samples
Blood sampling during PARP inhibitor therapy
Interventions
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blood samples
Blood sampling during PARP inhibitor therapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Locations
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CHRU Jean Minjoz
Besançon, , France
Centre Georges Francois Leclerc
Dijon, , France
Countries
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Other Identifiers
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2020-A00036-33
Identifier Type: -
Identifier Source: org_study_id