Microbiotic Analysis in Digestive Endocrine Tumors

Fecal Microbiota Clinical Trial

— MicroTEND  

Official title:

Microbiotic Analysis in Digestive Endocrine Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04198402
• Other study ID #: APHP190427
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: January 2023

Study information

• Verified date: November 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: IRADJ SOBHANI, MD-PHD
• Phone: 01 49 81 23 62
• Email: iradj.sobhani[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Signature
• Digestive Neuroendocrine Tumor
• Endocrine Gland Neoplasms
• Fecal Microbiota
• Neuroendocrine Tumors

Intervention

Biological:
• Biological sampling
Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial genomic signature	bacterial genomic signature by fecal ARN16S analysis at enrollment	Baseline visit