Small-intestine Neuroendocrine TumorsMicrobio-siNETNCT06624865
Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors
An observational study of Small-intestine Neuroendocrine Tumors, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of the study is to investigate the impact of the microenvironment on tumorigenesis of small intestinal neuroendocrine tumors often located in the terminal ileum, without identified driver mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-intestine Neuroendocrine Tumors
- What is being tested?
- Blood and stool sampling
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2024to Oct 2029
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: Consecutive patients followed at the Edouard Herriot University Hospital with small-intestine neuroendocrine tumors of the small intestine and indication for surgery.
Who may be able to join
- Patient with one or more small-intestine neuroendocrine tumor with indication of surgery
- Patient with consent for the collection, storage and reuse of data associated with his/her disease
- Age ≥ 18 years at the time of inclusion
- Non-objection statement obtained for participation in the study
Who cannot join
- Patients with poorly differentiated neuroendocrine carcinoma or NET (neuroendocrine tumors) of non-intestinal origin or mixed tumors (MiNEN)
- Pregnant, parturient or breast-feeding women
- Minors
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (guardianship, curatorship)
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
Edouard Herriot University Hospital
Lyon, France, 69003
Thomas WALTER, MD, PhD, 0472117398 ext. +33, thomas.walter@chu-lyon.fr
About this study
The aim of the study is to investigate the impact of the microenvironment on tumorigenesis of small intestinal neuroendocrine tumors often located in the terminal ileum, without identified driver mutations.
- Conditions
- Small-intestine Neuroendocrine Tumors
- Being tested
- Blood and stool sampling
- Keywords
- Small-intestine neuroendocrine tumor, microbiota, tumorigenesis
- Medical subject headings
- Carcinogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and stool samplingOther
Blood and stool sampling
| Study group | Role | What they receive |
|---|---|---|
| patient with indication for small-intestine neuroendocrine tumor surgery | The target population for this study is consecutive patients with small-intestine neuroendocrine tumor for whom surgery is indicated Receives: Other: Blood and stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of microbiota
Determination of the composition of blood, fecal, intra- and peri-tumoral microbiota in patients undergoing surgery for small-intestine neuroendocrine tumor.
Measured: At day 1 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start5 Nov 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-intestine Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624865
- Sponsor's protocol ID
- 69HCL23_1290
- Other IDs
- 2023-A02667-38
- Acronym
- Microbio-siNET
- Status last verified
- Apr 2025
- First submitted
- 30 Sep 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06624865
- Acronym / sponsor ID
- Microbio-siNET / 69HCL23_1290
- Conditions
- Small-intestine Neuroendocrine Tumors
- Keywords
- Small-intestine neuroendocrine tumor, microbiota, tumorigenesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 3 Oct 2024 (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 aim of the study is to investigate the impact of the microenvironment on tumorigenesis of small intestinal neuroendocrine tumors often located in the terminal ileum, without identified driver mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with indication for small-intestine neuroendocrine tumor surgery | – | Other: Blood and stool samplingThe target population for this study is consecutive patients with small-intestine neuroendocrine tumor for whom surgery is indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients followed at the Edouard Herriot University Hospital with small-intestine neuroendocrine tumors of the small intestine and indication for surgery.
Key inclusion criteria (4 listed)
- Patient with one or more small-intestine neuroendocrine tumor with indication of surgery
- Patient with consent for the collection, storage and reuse of data associated with his/her disease
- Age ≥ 18 years at the time of inclusion
- Non-objection statement obtained for participation in the study
Key exclusion criteria (5 listed)
- Patients with poorly differentiated neuroendocrine carcinoma or NET (neuroendocrine tumors) of non-intestinal origin or mixed tumors (MiNEN)
- Pregnant, parturient or breast-feeding women
- Minors
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (guardianship, curatorship)
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 and stool samplingBlood and stool sampling | Other | patient with indication for small-intestine neuroendocrine tumor surgery |
Primary outcome
Composition of microbiota
Time frame: At day 1 and month 3
Determination of the composition of blood, fecal, intra- and peri-tumoral microbiota in patients undergoing surgery for small-intestine neuroendocrine tumor.
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 4 Apr 2025.
Related trials for Small-intestine Neuroendocrine Tumors
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Active, not recruitingPhase 1
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
Advanced or Metastatic Solid Tumors
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Active, not recruitingPhase 2
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small-intestine Neuroendocrine Tumors, run by Hospices Civils de Lyon 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 4 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 4 Apr 2025. 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 Thomas WALTER, MD, PhD (0472117398 ext. +33, thomas.walter@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of microbiota (time frame: At day 1 and month 3). 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 4 Apr 2025.