Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways (MAB IN SITRO)

April 14, 2020 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Multicentric interventional prospective study with collection of biological samples as part of a routine care research

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

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

All

Description

Inclusion Criteria:

  1. Age greater than or equal to 18 years.
  2. Male and female sex.
  3. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE.
  4. Patient information and signed informed consent.
  5. Subjects affiliated (or beneficiary) to a social security scheme

Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria:

  1. History of severe systemic autoimmune disease.
  2. Pregnant or breastfeeding patient
  3. Impossibility or refusal to sign informed consent
  4. Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with cancer
Procedure: Tissue sampling
Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room
Procedure: Blood sampling
Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunophenotyping of immune infiltrates by flow cytometry
Time Frame: Up yo one year
Immunophenotyping analysis by flow cytometry (Cyan, Beckman Coulter): identification of several immune sub-populations (T-B-NK lymphocytes, myeloid and tumor cells); identifications of several receptors and ligands (PD1 / PDL1, Tim-3 / HAVCR2,, CTLA-4, 4-1BB / 4-1BBL, Fas / FasL, TRAIL, OX40 / OX40L, ICOS / ICOSL, CD69, CD25 / CD127, NKp46 / NKp30, NKG2D / NKG2DL, galectin-9, MHC class I and II, B7H3 / B7H6); identification of memory subpopulations (CD45RA / CD27 / CCR7) and, if available, intra-cytoplasmic labeling (CXCR3, CCR6, Granzyme B, KI67, TNFα IFNg, IL-17 and IL-21).
Up yo one year

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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)

September 8, 2016

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-A00732-49
  • 2015/2331 (Other Identifier: CSET number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe