Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

NCT ID: NCT04707365

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2035-03-31

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

digestive cancers

Colorectal and pancreatobiliary cancers

Group Type: EXPERIMENTAL

Tumor samples

Intervention Type: 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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pr Tournigand

Role: STUDY_DIRECTOR

AP-HP Henri Mondor Créteil

Central Contacts

Christophe Tournigand, MD-PHD

Role: CONTACT

christophe.tournigand@aphp.fr

0149812567 ext. 0033

Ilaria Cascone, PHD

Role: CONTACT

ilaria.cascone@u-pec.fr

0149813765 ext. 0033

Other Identifiers

IDRCB :2019-A00071-56

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190090

Identifier Type: -

Identifier Source: org_study_id