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
About this trial
This is an interventional prevention trial for Colorectal Cancer
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
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
NCT ID
NCT04707365
First Posted
January 12, 2021
Last Updated
January 12, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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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