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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Immune System and Related Disorders; Biliary Tract Tumor; Pancreas Tumor
• Intervention / Treatment: Biological: Tumor samples

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Tournigand, MD-PHD; Phone Number: 0033 0149812567; Email: christophe.tournigand@aphp.fr
• Study Contact Backup: Name: Ilaria Cascone, PHD; Phone Number: 0033 0149813765; Email: ilaria.cascone@u-pec.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Pr Tournigand, AP-HP Henri Mondor Créteil

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2035
• Study Completion (Anticipated): March 1, 2035

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: APHP190090; IDRCB :2019-A00071-56 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: AP-HP is the owner of the data and no use or transmission to a third party may be made without its prior consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No