Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms
NCT ID: NCT04363983
Last Updated: 2022-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6300 participants
INTERVENTIONAL
2021-01-13
2031-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Located/resected colorectal cancer
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.
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.
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.
Advanced colorectal cancer
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.
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.
Located/resected pancreatic cancer
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.
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.
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.
Advanced pancreatic cancer
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.
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.
Located/resected biliary tract cancer
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.
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.
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.
Advanced biliary tract cancer
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.
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.
Located/resected gastroesophageal cancer
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.
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.
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.
Advanced gastroesophageal cancer
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.
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.
Located/resected neuroendocrine cancer
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.
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.
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.
Advanced neuroendocrine cancer
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Frédérique PESCHAUD, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Digestive Surgery Department, Ambroise Paré Hospital, APHP
Cindy NEUZILLET, MD
Role: STUDY_DIRECTOR
Digestive Surgery Department, Ambroise Paré Hospital, APHP
Locations
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Digestive Surgery Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, , France
Countries
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Central Contacts
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Other Identifiers
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2019-A03330-57
Identifier Type: -
Identifier Source: org_study_id
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