Microbiotic Analysis in Digestive Endocrine Tumors (MicroTEND)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Fecal Microbiota; Digestive Neuroendocrine Tumor; Bacterial Signature

Treatments: Biological: Biological sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04198402

APHP190427

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Patient with digestive neuroendocrine tumor

Description:

naive patient with digestive neuroendocrine tumor (pancreas or small intestine), initiating Lanreotide treatment

Treatment:

Biological: Biological sampling

Patient without tumor

Description:

Historical control group (retrospective data) Patients, with normal endoscopic and body imaging results, having had fecal ARN16s sequencing who were assigned as control subjects for microbiota analyses.