Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

Colorectal Cancer Clinical Trial

— MICADO  

Official title:

Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04707365
• Other study ID #: APHP190090
• Secondary ID: IDRCB :2019-A000
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: March 2035

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christophe Tournigand, MD-PHD
• Phone: 0149812567
• Email: christophe.tournigand[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2035
• Est. primary completion date: March 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Tumor
• Colorectal Cancer
• Immune System and Related Disorders
• Neoplasms
• Pancreas Tumor

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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