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

NCT04675320 | Unknown

• 1 other identifier: 2020-A00036-33
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer

Keywords

PARP Inhibitors; immunomonitoring

Outcome Measures

Primary Outcomes (3)

• Immune response in plasma

  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

  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

  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

Study Arms (2)

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

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

Interventions

blood samples BIOLOGICAL

Blood sampling during PARP inhibitor therapy

First-line epithelial ovarian cancer (30 patients); Recurrent epithelial ovarian cancer (20 patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• nd 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.

You may not qualify if:

• Non-epithelial tumour of the ovary
• Patient unable to understand, read and/or sign informed consent.
• 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.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (2)

CHRU Jean Minjoz

Besançon, 25000, France

Location

Centre Georges Francois Leclerc

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

5 specific blood samples : * On the first day of anti-PARP treatment (before taking the first dose) * Second month of anti-PARP treatment * Fourth month of anti-PARP treatment * Sixth month of anti-PARP treatment * At relapse or cessation of anti-PARP treatment For each blood sample * 1 heparinized tube (5 mL) for plasmatheque * 1 heparinized tube (5 mL) for immunophenotyping, * 4 EDTA tubes (4 x 10 mL) for PBMC collection (cryopreservation). * 1 EDTA tube (10mL) for quantification of circulating tumor DNA.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 19, 2020
• Study Start: July 7, 2020
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-09

Locations

FR (2)