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NCT02297958 Clinical Trial

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

Ovarian Carcinoma Clinical Trial

— IFFaLCCO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02297958
Other study ID # 2014-A01041-46
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2015
Est. completion date July 27, 2019

Study information
Verified date August 2020
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date July 27, 2019
Est. primary completion date July 27, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Gynécologie Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery. surgery
Secondary Identification of tumoral T cells 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
Secondary Disease Free Survival rate 18 months after surgery
Secondary Overall survival rate 18 months after surgery
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