Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

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

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Key information

Conditions

Colorectal Cancer Biliary Tract Tumor Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Immune System and Related Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreas Tumor Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor samples

Biological

for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors

Primary outcomes

overall survival

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Tournigand, MD-PHD

CONTACT

[email protected]

0149812567 ext. 0033

Ilaria Cascone, PHD

CONTACT

[email protected]

0149813765 ext. 0033

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MICADO

Important dates

Study start: 2021
Primary completion: 2035
Study completion: 2035
First posted: Jan 13, 2021
Registry last updated: Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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