Viewing Study NCT02880046



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Study NCT ID: NCT02880046
Status: UNKNOWN
Last Update Posted: 2016-08-26
First Post: 2016-08-23

Brief Title: Study of Polyfunctionality of Anti-tumor T Lymphocytes in Cancerology Potential Biomarker for Emerging Immunotherapies
Sponsor: Central Hospital Nancy France
Organization: Central Hospital Nancy France

Study Overview

Official Title: Study of Polyfunctionality of Anti-tumor T Lymphocytes in Cancerology Potential Biomarker for Emerging Immunotherapies
Status: UNKNOWN
Status Verified Date: 2016-08
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: POLYTCANCER
Brief Summary: Purposes of this study are

Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro inhibition of PD-1PDL-1 pathway
Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of patients with melanoma lung cancer and renal carcinoma This cancers are chosen because of use of anti-PD-1 or anti-PDL-1 antibodies
Comparison of this technique with IFN-γ Elispot assay for detection and quantification of anti-tumor T lymphocytes after in vitro blockade of PD-1PDL-1 pathway
Detailed Description: In this study an immunomonitoring of specific responses of T lymphocytes to tumor-associated antigens based on detection of intracellular cytokines through flow cytometry after stimulation with all-tumor antigens and blockade of PD-1PDL-1 interaction is used Peripheral blood mononuclear cells of patients with cancers are stimulated with 4 telomerase-peptides or peptides overlapping the entire sequence of survivin

This project studies the frequency and role of polyfunctionality of anti-tumor T lymphocytes in cancerology with an in vitro technique detecting polyfunctional T lymphocytes with a better sensitivity based on removal of an inhibitory PD-1PDL-1 pathway It is a flow cytometry protocol with various theoretical advantages in terms of reproducibility and dynamic monitoring of functionality of different sub-populations of polyfunctional anti-tumor T lymphocytes Moreover it allows the study of molecular mechanisms involved in proliferation of polyfunctional anti-tumor T lymphocytes with the possibility to sort sub-populations

The use of all-tumor antigens allows the use of this technique to evaluate the presence and prognostic or predictive value of this biomarker in various cancers

Detection of polyfunctional anti-tumor T lymphocytes can be a biomarker of anti-tumor lymphocytic adaptive immunity and a potential eligibility or efficacy criteria for new immunotherapies such as anti-PD-1 or anti-PDL-1 treatments

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None