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Microbiotic Analysis in Digestive Endocrine Tumors (MicroTEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198402
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Digestive Neuroendocrine Tumor Fecal Microbiota Bacterial Signature Biological: Biological sampling

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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)

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: IRADJ SOBHANI, MD-PHD 01 49 81 23 62 ext 0033 iradj.sobhani@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04198402    
Other Study ID Numbers: APHP190427
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are own by Assistance Publique - Hopitaux de Paris, please contact sponsor for further information

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Endocrine Gland Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Site
Endocrine System Diseases