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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04349293

Acronym

MAB IN SITRO

Enrollment

150

Registered

2020-04-16

Start date

2016-09-08

Completion date

2021-09-30

Last updated

2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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

Interventions

PROCEDURETissue sampling

Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room

PROCEDUREBlood 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

France

Contacts

Primary ContactLaurence ZITVOGEL, MD, PhD

laurence.zitvogel@gustaveroussy.fr0142114211

Backup ContactAgathe DUBUISSON, PhD

agathe.dubuisson@gustaveroussy.fr0142114211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026