Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms (HoMING)

February 9, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study

The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).

Study Overview

Detailed Description

The study aims to explore relationship between the molecular subgroups (DNA and RNA analysis), tumor microenvironment, host (immunity system, premetastatic niche, microbiota, metabolism) and survival (prognostic value), response (predictive value) and tolerance (toxicities) to conventional treatments or immunotherapies in digestive cancers, in particular, in colorectal cancer and pancreaticobiliary cancer.

This is a prognostic monocentric study which includes 2 parts:

  • one retrospective observational cohort for which 150 eligible patients (who have being diagnosed between 1998 to 2020) will be entered in the cohort per year during 22 years targeting 3300 patients and
  • one prospective interventional cohort in which 3000 patients (diagnosis will be done between 2020-2030) will be enrolled during 10 years. 10 years of follow-up for all patients. This cohort is non comparative, non randomized, non control.

The enrollment will last 10 years in Digestive Surgery Department, Ambroise Paré Hospital, APHP.

There is any change in management of patients' care who will participate to the study, all of the treatment modalities (i.e. surgery, chemotherapy, radiotherapy, immunotherapy, intra-arterial treatments and supportive care) are possible and choice of treatment will be made by investigator physician, after multidisciplinary meeting validation, and according to referential and recommendations of practice in department.

Statistic analysis

The statistic analysis will be performed and reported according to the international guidelines STROBE for the observational studies.

Study Type

Interventional

Enrollment (Anticipated)

6300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Digestive Surgery Department, Ambroise Paré Hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Carcinoma of colorectal, pancreatic, biliary tract or gastro-oesophageal, or neuroendocrine digestive tumors with cytologically or histologically proven, regardless of the stage;
  • Diagnosis between 1998 and 2030;
  • Be >/= 18 years;
  • Have obtained signed informed consent (exemption for dead patients);
  • Affiliated to the French social security - welfare system in France (CMU included).

Exclusion Criteria:

  • Patient under tutoraship or curatorship;
  • Foreign patient under AME schema, a medical help from the state in France;
  • Pregnant or breastfeeding women (for prospective study);
  • Any clinical, psychological or social reason which should influence patient compliance with protocol, according to investigator;
  • Patient refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Located/resected colorectal cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients.

This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time.

This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Advanced colorectal cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Located/resected pancreatic cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients.

This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time.

This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Advanced pancreatic cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Located/resected biliary tract cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients.

This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time.

This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Advanced biliary tract cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Located/resected gastroesophageal cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients.

This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time.

This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Advanced gastroesophageal cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Located/resected neuroendocrine cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients.

This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time.

This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

Active Comparator: Advanced neuroendocrine cancer

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Following analysis should be performed with

  • serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
  • plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
  • PBMC for flow cytometry analysis, isolation macrophages;
  • whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).

Analysis will be performed for microbiota and metabolism analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: monthly up to 3 months
The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason).
monthly up to 3 months
Overall survival (OS)
Time Frame: yearly up to 10 years
The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason).
yearly up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival without disease (SWD)
Time Frame: at month 1, 2 and 3, then yearly up to 10 years
The SWD is defined as timeframe between date of surgical treatment and appearance of cancer relapse, 2nd cancer diagnosis or death (regardless reason).
at month 1, 2 and 3, then yearly up to 10 years
Survival without progression (SWP)
Time Frame: at month 1, 2 and 3, then yearly up to 10 years

The SWP is defined as timeframe between the beginning of treatment (date of 1st cure of chemotherapy/immunotherapy or date of 1st session of radiotherapy) and the 1st progression or death (regardless reason).

The response of tumor will be evaluated according to the RECIST v1.1, Choi (intra-arterial treatments, antiangiogenic therapy) and/or iRECIST (immunotherapies) and/or imaging examinations depending on the given treatments.

at month 1, 2 and 3, then yearly up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frédérique PESCHAUD, MD, PhD, Digestive Surgery Department, Ambroise Paré Hospital, APHP
  • Study Director: Cindy NEUZILLET, MD, Digestive Surgery Department, Ambroise Paré Hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Anticipated)

January 1, 2031

Study Completion (Anticipated)

January 1, 2031

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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