Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms
HoMING
1 other identifier
interventional
6,300
1 country
1
Brief Summary
The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedStudy Start
First participant enrolled
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
February 23, 2022
February 1, 2022
10 years
April 20, 2020
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
yearly up to 10 years
Secondary Outcomes (2)
Survival without disease (SWD)
at month 1, 2 and 3, then yearly up to 10 years
Survival without progression (SWP)
at month 1, 2 and 3, then yearly up to 10 years
Study Arms (10)
Located/resected colorectal cancer
ACTIVE COMPARATORAdvanced colorectal cancer
ACTIVE COMPARATORLocated/resected pancreatic cancer
ACTIVE COMPARATORAdvanced pancreatic cancer
ACTIVE COMPARATORLocated/resected biliary tract cancer
ACTIVE COMPARATORAdvanced biliary tract cancer
ACTIVE COMPARATORLocated/resected gastroesophageal cancer
ACTIVE COMPARATORAdvanced gastroesophageal cancer
ACTIVE COMPARATORLocated/resected neuroendocrine cancer
ACTIVE COMPARATORAdvanced neuroendocrine cancer
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Surgery Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, 92100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédérique PESCHAUD, MD, PhD
Digestive Surgery Department, Ambroise Paré Hospital, APHP
- STUDY DIRECTOR
Cindy NEUZILLET, MD
Digestive Surgery Department, Ambroise Paré Hospital, APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 27, 2020
Study Start
January 13, 2021
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
January 1, 2031
Last Updated
February 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share