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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

Tracking Information
First Submitted Date December 7, 2020
First Posted Date December 19, 2020
Last Update Posted Date December 19, 2020
Actual Study Start Date July 7, 2020
Estimated Primary Completion Date July 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2020)
blood analysis [ Time Frame: up to 6 months ]
immunophenotyping,plasma library and PBMC bank.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
Official Title Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood sample
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
Condition Ovarian Cancer
Intervention
  • Other: blood sample
    Olaparib
  • Other: blood sample
    Niraparib or Olaparib
Study Groups/Cohorts
  • Mutated BRCA epithelial ovarian cancer
    Intervention: Other: blood sample
  • Recurrent epithelial ovarian cancer
    Intervention: Other: blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 14, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 7, 2023
Estimated Primary Completion Date July 7, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jean-David FUMET 03 80 73 75 00 jdfumet@cgfl.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04675320
Other Study ID Numbers 2020-A00036-33
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Georges Francois Leclerc
Study Sponsor Centre Georges Francois Leclerc
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Georges Francois Leclerc
Verification Date December 2020