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

August 28, 2020 updated by: Rennes University Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
        • Service de Gynécologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient with ovarian carcinoma

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response
Time Frame: surgery
Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery.
surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of tumoral T cells
Time Frame: 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).
surgery
Disease Free Survival rate
Time Frame: 18 months after surgery
18 months after surgery
Overall survival rate
Time Frame: 18 months after surgery
18 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2015

Primary Completion (Actual)

July 27, 2019

Study Completion (Actual)

July 27, 2019

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01041-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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