Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer; Biliary Tract Tumor; Immune System and Related Disorders; Pancreas Tumor
• Interventions: Biological: Tumor samples

• Registration Number: NCT04707365
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13
• Study Start: 2021-03
• Primary Completion: 2035-03
• Study Completion: 2035-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
digestive cancers	Tumor samples	Colorectal and pancreatobiliary cancers

Primary Outcome Measures

Name	Time	Method
overall survival	observation from first cancer treatment date until date of death or 10 years follow up if patient alive	Overall survival (OS): vital status (alive/deceased)