Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

Study Overview
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Brief Summary
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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

Official Title
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Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment

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

Intervention / Treatment
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* Biological: Tumor samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Retrospective and prospective monocentric cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: digestive cancers<br>Colorectal and pancreatobiliary cancers | Biological: Tumor samples<br>* for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival (OS): vital status (alive/deceased) | observation from first cancer treatment date until date of death or 10 years follow up if patient alive |