Microbiotic Analysis in Digestive Endocrine Tumors

NCT04198402 | Unknown

• 1 other identifier: APHP190427
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Digestive Neuroendocrine Tumor; Fecal Microbiota; Bacterial Signature

Outcome Measures

Primary Outcomes (1)

• bacterial genomic signature

  bacterial genomic signature by fecal ARN16S analysis at enrollment

  Baseline visit

Study Arms (2)

Patient with digestive neuroendocrine tumor

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

Biological: Biological sampling

Patient without tumor

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.

Interventions

Biological sampling BIOLOGICAL

Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing

Patient with digestive neuroendocrine tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Naive patient with digestive neuroendocrine tumor (pancreas (cytology or histology per endoscopy or on surgical specimen) or small intestine), secreting or not, going to receive Lanreotide treatment as the first line therapy for their disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal sample blood sample blood sample is part of routine medical care and fecal sample is a non invasive collection of elements from human body, allowing the study to be categorised as a non-interventional research (approved by ethics commitee) Please see: "Arrêté du 12 avril 2018 fixant la liste des recherches mentionnées au 3° de l'article L. 1121-1 du code de la santé publique" , justifying observational study type

Central Study Contacts

IRADJ SOBHANI, MD-PHD

CONTACT

01 49 81 23 62; iradj.sobhani@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share