Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms
- Conditions
- Gastrointestinal Neoplasms
- Interventions
- Biological: Blood samplingBiological: Stool collectProcedure: Liver biopsy
- Registration Number
- NCT04363983
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6300
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Located/resected pancreatic cancer Blood sampling - Advanced pancreatic cancer Stool collect - Located/resected gastroesophageal cancer Blood sampling - Located/resected colorectal cancer Liver biopsy - Advanced colorectal cancer Stool collect - Located/resected pancreatic cancer Liver biopsy - Located/resected pancreatic cancer Stool collect - Advanced biliary tract cancer Blood sampling - Located/resected biliary tract cancer Stool collect - Advanced gastroesophageal cancer Blood sampling - Located/resected neuroendocrine cancer Blood sampling - Located/resected colorectal cancer Blood sampling - Located/resected colorectal cancer Stool collect - Advanced colorectal cancer Blood sampling - Advanced pancreatic cancer Blood sampling - Located/resected gastroesophageal cancer Liver biopsy - Advanced gastroesophageal cancer Stool collect - Advanced neuroendocrine cancer Stool collect - Located/resected biliary tract cancer Blood sampling - Located/resected biliary tract cancer Liver biopsy - Advanced biliary tract cancer Stool collect - Located/resected gastroesophageal cancer Stool collect - Located/resected neuroendocrine cancer Liver biopsy - Located/resected neuroendocrine cancer Stool collect - Advanced neuroendocrine cancer Blood sampling -
- Primary Outcome Measures
Name Time Method Overall survival (OS) 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).
- Secondary Outcome Measures
Name Time Method Survival without disease (SWD) 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).
Survival without progression (SWP) 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.
Trial Locations
- Locations (1)
Digestive Surgery Department, Ambroise Paré Hospital, APHP
🇫🇷Boulogne-Billancourt, France