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Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms

NCT04363983 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6300

Last updated 2022-02-23

No results posted yet for this study

Summary

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

Conditions

  • Gastrointestinal Neoplasms

Interventions

BIOLOGICAL

Blood sampling

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.

PROCEDURE

Liver biopsy

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.

BIOLOGICAL

Stool collect

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Frédérique PESCHAUD, MD, PhD · Digestive Surgery Department, Ambroise Paré Hospital, APHP

  • Cindy NEUZILLET, MD · Digestive Surgery Department, Ambroise Paré Hospital, APHP

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363983 on ClinicalTrials.gov