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

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ClinicalTrials.gov Identifier: NCT04675320
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:
This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancerin in order to describe the immune response with PARP inhibitors.

Condition or disease Intervention/treatment
Ovarian Cancer 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.

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Study Type : Observational
Estimated 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 : July 7, 2020
Estimated Primary Completion Date : July 7, 2021
Estimated Study Completion Date : July 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
Mutated BRCA epithelial ovarian cancer Other: blood sample
Olaparib

Recurrent epithelial ovarian cancer Other: blood sample
Niraparib or Olaparib




Primary Outcome Measures :
  1. blood analysis [ Time Frame: up to 6 months ]
    immunophenotyping,plasma library and PBMC bank.


Biospecimen Retention:   Samples With DNA
blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cohorte 1 : patients with Mutated BRCA epithelial ovarian cancer - interviewed by Olaparib cohorte 2 : patients with Recurrent epithelial ovarian cancer - maintained with Niraparib or Olaparib
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675320


Contacts
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Contact: Jean-David FUMET 03 80 73 75 00 jdfumet@cgfl.fr

Locations
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France
CHRU Jean Minjoz Recruiting
Besançon, France, 25000
Principal Investigator: Fernando BAZAN         
Sub-Investigator: Elsa KALBACHER         
Sub-Investigator: Laura MANSI         
Sub-Investigator: Guillaume MEYNARD         
Centre Georges Francois Leclerc Recruiting
Dijon, France, 21000
Principal Investigator: Jean David FUMET         
Sub-Investigator: Isabelle DESOULIN         
Sub-Investigator: Sylvia ILIE         
Sub-Investigator: Audrey HENNEQUIN         
Sub-Investigator: Courèche KADERBHAI         
Sub-Investigator: Alice HERVIEU         
Sub-Investigator: Leila BENGRINE         
Sub-Investigator: Laure FAVIER         
Sponsors and Collaborators
Centre Georges Francois Leclerc
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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT04675320    
Other Study ID Numbers: 2020-A00036-33
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type