Gastrointestinal NeoplasmsHoMINGNCT04363983
Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms
A study testing Blood sampling, Liver biopsy and Stool collect in people with Gastrointestinal Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Blood sampling, Liver biopsy and Stool collect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,300 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Digestive Surgery Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study
The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).
Read the 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.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- Blood sampling, Liver biopsy, Stool collect
- Keywords
- gastrointestinal cancer, micro-environment, immunity, host, microbiota
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
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 biopsyProcedure or surgery
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 collectBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Located/resected colorectal cancer | Active comparator | Not described Receives: Biological: Blood sampling; Procedure: Liver biopsy; Biological: Stool collect |
| Advanced colorectal cancer | Active comparator | Not described Receives: Biological: Blood sampling; Biological: Stool collect |
| Located/resected pancreatic cancer | Active comparator | Not described Receives: Biological: Blood sampling; Procedure: Liver biopsy; Biological: Stool collect |
| Advanced pancreatic cancer | Active comparator | Not described Receives: Biological: Blood sampling; Biological: Stool collect |
| Located/resected biliary tract cancer | Active comparator | Not described Receives: Biological: Blood sampling; Procedure: Liver biopsy; Biological: Stool collect |
| Advanced biliary tract cancer | Active comparator | Not described Receives: Biological: Blood sampling; Biological: Stool collect |
| Located/resected gastroesophageal cancer | Active comparator | Not described Receives: Biological: Blood sampling; Procedure: Liver biopsy; Biological: Stool collect |
| Advanced gastroesophageal cancer | Active comparator | Not described Receives: Biological: Blood sampling; Biological: Stool collect |
| Located/resected neuroendocrine cancer | Active comparator | Not described Receives: Biological: Blood sampling; Procedure: Liver biopsy; Biological: Stool collect |
| Advanced neuroendocrine cancer | Active comparator | Not described Receives: Biological: Blood sampling; Biological: Stool collect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: yearly up to 10 years
Secondary outcomes (2)
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).
Measured: 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.
Measured: at month 1, 2 and 3, then yearly up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start13 Jan 2021
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique PESCHAUD, MD, PhD, Principal investigator, Digestive Surgery Department, Ambroise Paré Hospital, APHPCindy NEUZILLET, MD, Study director, Digestive Surgery Department, Ambroise Paré Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363983
- Sponsor's protocol ID
- 2019-A03330-57
- Acronym
- HoMING
- Status last verified
- Feb 2022
- First submitted
- 20 Apr 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04363983
- Acronym / sponsor ID
- HoMING / 2019-A03330-57
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- gastrointestinal cancer, micro-environment, immunity, host, microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Located/resected colorectal cancer | Active comparator | Biological: Blood sampling, Procedure: Liver biopsy, Biological: Stool collect |
| Advanced colorectal cancer | Active comparator | Biological: Blood sampling, Biological: Stool collect |
| Located/resected pancreatic cancer | Active comparator | Biological: Blood sampling, Procedure: Liver biopsy, Biological: Stool collect |
| Advanced pancreatic cancer | Active comparator | Biological: Blood sampling, Biological: Stool collect |
| Located/resected biliary tract cancer | Active comparator | Biological: Blood sampling, Procedure: Liver biopsy, Biological: Stool collect |
| Advanced biliary tract cancer | Active comparator | Biological: Blood sampling, Biological: Stool collect |
| Located/resected gastroesophageal cancer | Active comparator | Biological: Blood sampling, Procedure: Liver biopsy, Biological: Stool collect |
| Advanced gastroesophageal cancer | Active comparator | Biological: Blood sampling, Biological: Stool collect |
| Located/resected neuroendocrine cancer | Active comparator | Biological: Blood sampling, Procedure: Liver biopsy, Biological: Stool collect |
| Advanced neuroendocrine cancer | Active comparator | Biological: Blood sampling, Biological: Stool collect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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. | Biological | Advanced biliary tract cancer, Advanced colorectal cancer, Advanced gastroesophageal cancer, Advanced neuroendocrine cancer, Advanced pancreatic cancer, Located/resected biliary tract cancer, Located/resected colorectal cancer, Located/resected gastroesophageal cancer, Located/resected neuroendocrine cancer, Located/resected pancreatic cancer |
| Liver biopsyAn 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. | Procedure or surgery | Located/resected biliary tract cancer, Located/resected colorectal cancer, Located/resected gastroesophageal cancer, Located/resected neuroendocrine cancer, Located/resected pancreatic cancer |
| Stool collectStool 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. | Biological | Advanced biliary tract cancer, Advanced colorectal cancer, Advanced gastroesophageal cancer, Advanced neuroendocrine cancer, Advanced pancreatic cancer, Located/resected biliary tract cancer, Located/resected colorectal cancer, Located/resected gastroesophageal cancer, Located/resected neuroendocrine cancer, Located/resected pancreatic cancer |
Primary outcome
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).
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).
2 secondary outcomes
Survival without disease (SWD)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédérique PESCHAUD, MD, PhD principal investigator
Digestive Surgery Department, Ambroise Paré Hospital, APHP
Cindy NEUZILLET, MD study director
Digestive Surgery Department, Ambroise Paré Hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Liver biopsy and Stool collect in people with Gastrointestinal Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédérique PESCHAUD, MD, PhD (+33 1 49 09 53 35, frederique.peschaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: monthly up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022; AzTrials last refreshed its copy on 26 Oct 2026.