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

Gustave Roussy

Status: Unknown

Conditions: Cancer

Treatments: Procedure: Tissue sampling; Procedure: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04349293

2016-A00732-49

2015/2331 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Patients with cancer

Experimental group

Treatment:

Procedure: Tissue sampling

Procedure: Blood sampling