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

Primary Purpose

Colorectal Cancer, Pancreas Tumor, Biliary Tract Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tumor samples
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    digestive cancers

    Arm Description

    Colorectal and pancreatobiliary cancers

    Outcomes

    Primary Outcome Measures

    overall survival
    Overall survival (OS): vital status (alive/deceased)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2021
    Last Updated
    January 12, 2021
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04707365
    Brief Title
    Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort
    Acronym
    MICADO
    Official Title
    Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    March 2035 (Anticipated)
    Study Completion Date
    March 2035 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Pancreas Tumor, Biliary Tract Tumor, Immune System and Related Disorders

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Retrospective and prospective monocentric cohort study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    digestive cancers
    Arm Type
    Experimental
    Arm Description
    Colorectal and pancreatobiliary cancers
    Intervention Type
    Biological
    Intervention Name(s)
    Tumor samples
    Intervention Description
    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 Measure Information:
    Title
    overall survival
    Description
    Overall survival (OS): vital status (alive/deceased)
    Time Frame
    observation from first cancer treatment date until date of death or 10 years follow up if patient alive

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christophe Tournigand, MD-PHD
    Phone
    0149812567
    Ext
    0033
    Email
    christophe.tournigand@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ilaria Cascone, PHD
    Phone
    0149813765
    Ext
    0033
    Email
    ilaria.cascone@u-pec.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pr Tournigand
    Organizational Affiliation
    AP-HP Henri Mondor Créteil
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.

    Learn more about this trial

    Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

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