Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort (MICADO)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Immune System and Related Disorders; Biliary Tract Tumor; Pancreas Tumor; Colorectal Cancer

Treatments: Biological: Tumor samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04707365

IDRCB :2019-A00071-56 (Other Identifier)

APHP190090

Details and patient eligibility

About

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.

Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.

Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.

Method: Retrospective and prospective monocentric cohort study

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colorectal or pancreatic adenocarcinoma or biliary tract adenocarcinoma
• Cytologically or histologically proven adenocarcinoma, regardless of stage and treatment
• Age ≥ 18 years old
• Diagnosed from 2015 onwards
• Signed Consent
• Affiliation to a social security scheme (including CMU (Universal health coverage))

Exclusion criteria

• Patient under guardianship, curatorship or safeguarding of justice
• Pregnant or breastfeeding woman
• Any medical, psychological or social situation that could prevent compliance with the protocol according to the investigator's assessment.
• Refusal to participate in the study
• Patient on AME (state medical assistance)
• Persons deprived of liberty by a judicial or administrative decision
• Persons under psychiatric care

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

digestive cancers

Experimental group

Description:

Colorectal and pancreatobiliary cancers

Treatment:

Biological: Tumor samples