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

Sponsor
Centre Georges Francois Leclerc (Other)
Overall Status
Recruiting
CT.gov ID
NCT04675320
Collaborator
(none)
50
Enrollment
2
Locations
54.1
Anticipated Duration (Months)
25
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: blood sample
  • Other: blood sample

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
Actual Study Start Date :
Jun 3, 2020
Anticipated Primary Completion Date :
Dec 7, 2022
Anticipated Study Completion Date :
Dec 7, 2024

Arms and Interventions

Arm Intervention/Treatment
Mutated BRCA epithelial ovarian cancer

Other: blood sample
Olaparib
Recurrent epithelial ovarian cancer

Other: blood sample
Niraparib or Olaparib

Outcome Measures

Primary Outcome Measures

  1. blood analysis [up to 6 months]

    immunophenotyping,plasma library and PBMC bank.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Epithelial Ovarian Cancer

  • Eligible for treatment by anti-PARP treatment with Olaparib or Niraparib

  • informed consent signed

Exclusion Criteria:

  • Non Epithelial Ovarian Cancer

  • Current or previous use of an immunosuppressive drug 14 days before inclusion

  • Pregnant or breastfeeding woman.

  • VIH et/ou VHB et/ou VHC positive

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Jean Minjoz Besançon France 25000
2 Centre Georges Francois Leclerc Dijon France 21000

Sponsors and Collaborators

  • Centre Georges Francois Leclerc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:
NCT04675320
Other Study ID Numbers:
  • 2020-A00036-33
First Posted:
Dec 19, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Georges Francois Leclerc
PARP Inhibitors
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Mar 25, 2022