Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling, Liver biopsy, Stool collect.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study
Overview
The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).
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.
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 pro - 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 pa - 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.
Primary outcome measures
- Overall survival (OS) [Time frame: monthly up to 3 months]
- Overall survival (OS) [Time frame: yearly up to 10 years]
Secondary outcome measures (2)
- Survival without disease (SWD) [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Digestive Surgery Department, Ambroise Paré Hospital, APHP — Boulogne-Billancourt
Identifiers
NCT: NCT04363983 · 2019-A03330-57