Microbiotic Analysis in Digestive Endocrine Tumors (MicroTEND)
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|ClinicalTrials.gov Identifier: NCT04198402|
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
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.
|Condition or disease||Intervention/treatment|
|Digestive Neuroendocrine Tumor Fecal Microbiota Bacterial Signature||Biological: Biological sampling|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Microbiotic Analysis in Digestive Endocrine Tumors|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Patient with digestive neuroendocrine tumor
naive patient with digestive neuroendocrine tumor (pancreas or small intestine), initiating Lanreotide treatment
Biological: Biological sampling
Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing
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.
- bacterial genomic signature [ Time Frame: Baseline visit ]bacterial genomic signature by fecal ARN16S analysis at enrollment
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)
"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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198402
|Contact: IRADJ SOBHANI, MD-PHD||01 49 81 23 62 ext email@example.com|