Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

Not Applicable

• Conditions: Cancer
• Interventions: Procedure: Tissue sampling; Procedure: Blood sampling

• Registration Number: NCT04349293
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

Multicentric interventional prospective study with collection of biological samples as part of a routine care research

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-16
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with cancer	Tissue sampling	-
Patients with cancer	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
Immunophenotyping of immune infiltrates by flow cytometry	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).

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France