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Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort


2021-03


2035-03


2035-03


200

Study Overview

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

N/A

  • Colorectal Cancer
  • Pancreas Tumor
  • Biliary Tract Tumor
  • Immune System and Related Disorders
  • BIOLOGICAL: Tumor samples
  • APHP190090
  • IDRCB :2019-A00071-56 (OTHER Identifier) (OTHER: ANSM)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-01-12  

N/A  

2021-01-12  

2021-01-12  

N/A  

2021-01-13  

2021-01-13  

N/A  

2020-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime Frame
overall survivalOverall survival (OS): vital status (alive/deceased)observation from first cancer treatment date until date of death or 10 years follow up if patient alive
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Christophe Tournigand, MD-PHD

Phone Number: 0149812567

Email: christophe.tournigand@aphp.fr

Study Contact Backup

Name: Ilaria Cascone, PHD

Phone Number: 0149813765

Email: ilaria.cascone@u-pec.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • STUDY_DIRECTOR: Pr Tournigand, AP-HP Henri Mondor Créteil

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available