- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363983
Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms (HoMING)
Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frédérique PESCHAUD, MD, PhD
- Phone Number: +33 1 49 09 53 35
- Email: frederique.peschaud@aphp.fr
Study Contact Backup
- Name: Cindy NEUZILLET, MD
- Phone Number: +33 1 47 11 15 15
- Email: cindy.neuzillet@gmail.com
Study Locations
-
-
-
Boulogne-Billancourt, France, 92100
- Recruiting
- Digestive Surgery Department, Ambroise Paré Hospital, APHP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Located/resected colorectal cancer
|
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
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. |
Active Comparator: Advanced colorectal cancer
|
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
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. |
Active Comparator: Located/resected pancreatic cancer
|
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
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. |
Active Comparator: Advanced pancreatic cancer
|
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
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. |
Active Comparator: Located/resected biliary tract cancer
|
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
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. |
Active Comparator: Advanced biliary tract cancer
|
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
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. |
Active Comparator: Located/resected gastroesophageal cancer
|
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
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. |
Active Comparator: Advanced gastroesophageal cancer
|
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
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. |
Active Comparator: Located/resected neuroendocrine cancer
|
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
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. |
Active Comparator: Advanced neuroendocrine cancer
|
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
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: monthly up to 3 months
|
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)
Time Frame: 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).
|
yearly up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival without disease (SWD)
Time Frame: 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).
|
at month 1, 2 and 3, then yearly up to 10 years
|
Survival without progression (SWP)
Time Frame: 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. |
at month 1, 2 and 3, then yearly up to 10 years
|
Collaborators and Investigators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A03330-57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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