Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

NCT04707365 | Not Yet Recruiting

• 2 other identifiers: APHP190090IDRCB :2019-A00071-56
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

digestive cancers

EXPERIMENTAL

Colorectal and pancreatobiliary cancers

Biological: Tumor samples

Interventions

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

digestive cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Pr Tournigand

  AP-HP Henri Mondor Créteil

  STUDY DIRECTOR

Central Study Contacts

Christophe Tournigand, MD-PHD

CONTACT

0149812567; christophe.tournigand@aphp.fr

Ilaria Cascone, PHD

CONTACT

0149813765; ilaria.cascone@u-pec.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retrospective and prospective monocentric cohort study

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): March 1, 2035
• Study Completion (Estimated): March 1, 2035
• Last Updated: January 13, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share