Microbiota and Carcinogenesis of Small-intestine Neuroend... | NCT06624865

Studies
Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors

NCT06624865

Sponsor

Hospices Civils de Lyon

Status

Recruiting

Last Update Posted

Apr 4, 2025Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Small-intestine Neuroendocrine Tumors

Interventions

Blood and stool sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A02667-38	Other Identifier	ANSM

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2024Actual

Primary Completion Date

Oct 2029Estimated

Completion Date

Oct 2029Estimated

First Submitted Date

Sep 30, 2024

First Submission Date that Met QC Criteria

Sep 30, 2024

First Posted Date

Oct 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2025

Last Update Posted Date

Apr 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood and stool sampling	Other	Blood and stool sampling	patient with indication for small-intestine neuroendocrine tumor surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composition of microbiota	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas WALTER, MD, PhD	Contact	0472117398	+33	thomas.walter@chu-lyon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edouard Herriot University Hospital	Recruiting	Lyon	France	69003	France

Condition Browse Module

MeSH Terms

ID	Term
D063646	Carcinogenesis

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided