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

Ovarian Cancer Clinical Trial

— IMMUNOPARP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04675320
• Other study ID #: 2020-A00036-33
• Status: Active, not recruiting
• Start date: July 7, 2020
• Est. completion date: November 10, 2024

Study information

• Verified date: September 2023
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 10, 2024
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• blood samples
Blood sampling during PARP inhibitor therapy

Locations

Country	Name	City	State
France	CHRU Jean Minjoz	Besançon
France	Centre Georges Francois Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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