Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
MAB IN SITRO
2 other identifiers
interventional
150
1 country
1
Brief Summary
Multicentric interventional prospective study with collection of biological samples as part of a routine care research
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Sep 2016
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedApril 16, 2020
April 1, 2020
5 years
April 14, 2020
April 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Immunophenotyping of immune infiltrates by flow cytometry
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
Study Arms (1)
Patients with cancer
EXPERIMENTALInterventions
Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room
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)
Eligibility Criteria
You may qualify if:
- 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.).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gustave Roussy
Villejuif, Val De Marne, 94800, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 16, 2020
Study Start
September 8, 2016
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
April 16, 2020
Record last verified: 2020-04