Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors (Microbio-siNET)

April 3, 2025 updated by: Hospices Civils de Lyon
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Edouard Herriot University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients followed at the Edouard Herriot University Hospital with small-intestine neuroendocrine tumors of the small intestine and indication for surgery.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Blood and stool sampling
Blood and stool sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At day 1 and month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_1290
  • 2023-A02667-38 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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