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

What this Trial Is About

Researchers are investigating the relationship between molecular subgroups, tumor microenvironment, host factors such as immunity, microbiota, and metabolism, and how these influence survival, treatment response, and tolerance in digestive cancers, especially colorectal and pancreaticobiliary cancers. This study is a prognostic monocentric research combining a retrospective observational cohort of patients diagnosed between 1998 and 2020 and a prospective interventional cohort enrolling patients diagnosed from 2020 to 2030, with a total follow-up of 10 years. The study involves two parts: a retrospective cohort including about 3300 patients over 22 years and a prospective cohort enrolling 3000 patients over 10 years. Treatments such as surgery, chemotherapy, radiotherapy, immunotherapy, and supportive care continue as usual based on physician decisions and multidisciplinary meetings. Biological samples like blood and stool are collected at multiple time points, and intraoperative liver biopsies are performed for local resected patients to study liver changes related to metastasis risk. Participants will provide blood and stool samples at baseline, after surgery, and during treatment periods. Liver biopsies will be done during surgery for some patients. Researchers will analyze these samples for proteins, RNA, DNA, tumor markers, microbiota, and immune cells. They will monitor overall survival monthly for the first 3 months and yearly up to 10 years, along with survival without disease progression. The study includes clinical follow-up and statistical analysis according to international guidelines to understand prognostic and predictive factors in digestive cancers.

Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms