Microenvironment and Immunity of Digestive Cancers - East... | NCT04707365

Studies
Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

NCT04707365

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Not yet recruiting

Last Update Posted

Jan 13, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

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

Interventions

Tumor samples

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDRCB :2019-A00071-56	Other Identifier	ANSM

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2021Estimated

Primary Completion Date

Mar 2035Estimated

Completion Date

Mar 2035Estimated

First Submitted Date

Jan 12, 2021

First Submission Date that Met QC Criteria

Jan 12, 2021

First Posted Date

Jan 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2021

Last Update Posted Date

Jan 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
digestive cancers	Experimental	Colorectal and pancreatobiliary cancers	Biological: Tumor samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tumor samples	Biological	for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe Tournigand, MD-PHD	Contact	0149812567	0033	christophe.tournigand@aphp.fr
Ilaria Cascone, PHD	Contact	0149813765	0033	ilaria.cascone@u-pec.fr

Overall Officials

Name	Affiliation	Role
Pr Tournigand	AP-HP Henri Mondor Créteil	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided