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IFFaLCCO: Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02297958
Collaborator
(none)
28
Enrollment
1
Location
54.3
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    28 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma
    Actual Study Start Date :
    Jan 15, 2015
    Actual Primary Completion Date :
    Jul 27, 2019
    Actual Study Completion Date :
    Jul 27, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response [surgery]

      Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery.

    Secondary Outcome Measures

    1. Identification of tumoral T cells [surgery]

      Identification of tumoral T cells with FACS analysis of dissociated tumor. Different T cells will be studies: Treg/Th17/Th1/Th2 using antibodies against: CD45/CD3/CD4/CD25/FOXP3 (Treg), CD45/CD3/CD4/IL17A (Th17), CD45/CD3/CD4/CD8/IL4/INF (TCD8 and LTCD4 Th1 et Th2).

    2. Disease Free Survival rate [18 months after surgery]

    3. Overall survival rate [18 months after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Pre-Inclusion Criteria:
    • Patient with suspicious ovarian carcinoma using clinical data, biological data (ca125) and radiological data (CT)
    Inclusion Criteria:

    • Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.

    • Neo adjuvant chemotherapy

    Exclusion Criteria:

    • no neo-adjuvant chemotherapy

    • no ovarian carcinoma at final pathological analysis

    • less than 18 years old.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Gynécologie Rennes France

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Vincent Lavoue, PH, Rennes University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT02297958
    Other Study ID Numbers:
    • 2014-A01041-46
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Aug 31, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Carcinoma
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Aug 31, 2020