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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04707365
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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


Condition or disease Intervention/treatment Phase
Colorectal Cancer Pancreas Tumor Biliary Tract Tumor Immune System and Related Disorders Biological: Tumor samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Retrospective and prospective monocentric cohort study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2035
Estimated Study Completion Date : March 2035

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707365


Contacts
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Contact: Christophe Tournigand, MD-PHD 0149812567 ext 0033 christophe.tournigand@aphp.fr
Contact: Ilaria Cascone, PHD 0149813765 ext 0033 ilaria.cascone@u-pec.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Pr Tournigand AP-HP Henri Mondor Créteil
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04707365    
Other Study ID Numbers: APHP190090
IDRCB :2019-A00071-56 ( Other Identifier: ANSM )
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases