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

December 6, 2023 updated by: Centre Georges Francois Leclerc
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHRU Jean Minjoz
      • Dijon, France, 21000
        • Centre Georges Francois Leclerc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • Cohort 1: Maintenance treatment of adult patients with newly diagnosed BRCA1/2-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) who have had a partial or complete response to first-line platinum-based chemotherapy. BRCA-mutated epithelial ovarian cancer - maintenance with Olaparib / Niraparib or Olaparib + bevacizumab
  • Cohort 2: Single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who are responding (complete or partial) to platinum-based chemotherapy. Recurrent epithelial ovarian cancer - maintenance with Niraparib or Olaparib

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: 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.
Biological: blood samples
Blood sampling during PARP inhibitor therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response in plasma
Time Frame: 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
From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
Immune response in PBMC
Time Frame: 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
From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
Immune response in tumor DNA
Time Frame: 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
From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Actual)

November 10, 2022

Study Completion (Estimated)

November 10, 2024

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00036-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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