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Clinical Trials/NCT04349293
NCT04349293
Unknown
Not Applicable

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

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country150 target enrollmentSeptember 8, 2016
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
150
Locations
1
Primary Endpoint
Immunophenotyping of immune infiltrates by flow cytometry
Last Updated
6 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 8, 2016
End Date
September 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age greater than or equal to 18 years.
  • Male and female sex.
  • 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.
  • Patient information and signed informed consent.
  • Subjects affiliated (or beneficiary) to a social security scheme
  • Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria

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

Outcomes

Primary Outcomes

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).

Study Sites (1)

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