An interventional study of Blood sampling and Liver biopsy in Gastrointestinal Neoplasms, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 6,300 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Biological: Blood sampling · Procedure: Liver biopsy · Biological: Stool collect
Biological: Blood sampling · Biological: Stool collect
Biological: Blood sampling · Procedure: Liver biopsy · Biological: Stool collect
Biological: Blood sampling · Biological: Stool collect
Biological: Blood sampling · Procedure: Liver biopsy · Biological: Stool collect
Biological: Blood sampling · Biological: Stool collect
Biological: Blood sampling · Procedure: Liver biopsy · Biological: Stool collect
Biological: Blood sampling · Biological: Stool collect
Biological: Blood sampling · Procedure: Liver biopsy · Biological: Stool collect
Biological: Blood sampling · Biological: Stool collect
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.
Overall survival (OS)
The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason).
Time frame: monthly up to 3 months
Overall survival (OS)
The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason).
Time frame: yearly up to 10 years
Survival without disease (SWD)
The SWD is defined as timeframe between date of surgical treatment and appearance of cancer relapse, 2nd cancer diagnosis or death (regardless reason).
Time frame: at month 1, 2 and 3, then yearly up to 10 years
Survival without progression (SWP)
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.
Time frame: at month 1, 2 and 3, then yearly up to 10 years
Plan to share: No
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Assistance Publique - Hôpitaux de Paris