Microbiotic Analysis in Digestive Endocrine Tumors

• Conditions: Fecal Microbiota; Digestive Neuroendocrine Tumor; Bacterial Signature
• Interventions: Biological: Biological sampling

• Registration Number: NCT04198402
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Incidence of digestive neuroendocrine tumors are increasing. Analysis of individual microbiota is a way to explore new neoplastic mechanisms, tumor identification and therapeutic orientations. This prospective pilot study aims to describe fecal bacterial phylogeny of patients with digestive neuroendocrine tumor.

Bacterial genomic signature will be recorded at initiation of Lanreotide treatment in naive patient with digestive neuroendocrine tumor (pancreas or small intestine), metastatic or locally advanced, as well as after one year follow up.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13
• Study Start: 2020-01
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years old or older
• naive patient with digestive neuroendocrine tumor (pancreas (cytology or histology per endoscopy or on surgical specimen) or small intestine), secreting or not, initiating a extended release Lanreotide treatment
• registered with a social security scheme

Exclusion Criteria

• medical contraindication to somatostatine analogs use
• history of extended release somatostatine analogs treatment
• antibiotic use or colonoscopic purge in the last 3 weeks preceding fecal sample
• pregnant or breastfeeding women
• person requiring tutorship, guardianship, or person legally protected

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with digestive neuroendocrine tumor	Biological sampling	naive patient with digestive neuroendocrine tumor (pancreas or small intestine), initiating Lanreotide treatment

Primary Outcome Measures

Name	Time	Method
bacterial genomic signature	Baseline visit	bacterial genomic signature by fecal ARN16S analysis at enrollment