Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT04198402
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiotic Analysis in Digestive Endocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fecal sample blood sample\n\nblood 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)\n\nPlease see:\n\n"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'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacterial genomic signature', 'timeFrame': 'Baseline visit', 'description': 'bacterial genomic signature by fecal ARN16S analysis at enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Digestive Neuroendocrine Tumor', 'Fecal Microbiota', 'Bacterial Signature']}, 'descriptionModule': {'briefSummary': '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.\n\nBacterial 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* 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\n* registered with a social security scheme\n\nExclusion Criteria:\n\n* medical contraindication to somatostatine analogs use\n* history of extended release somatostatine analogs treatment\n* antibiotic use or colonoscopic purge in the last 3 weeks preceding fecal sample\n* pregnant or breastfeeding women\n* person requiring tutorship, guardianship, or person legally protected'}, 'identificationModule': {'nctId': 'NCT04198402', 'acronym': 'MicroTEND', 'briefTitle': 'Microbiotic Analysis in Digestive Endocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Microbiotic Analysis in Digestive Endocrine Tumors', 'orgStudyIdInfo': {'id': 'APHP190427'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with digestive neuroendocrine tumor', 'description': 'naive patient with digestive neuroendocrine tumor (pancreas or small intestine), initiating Lanreotide treatment', 'interventionNames': ['Biological: Biological sampling']}, {'label': '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.'}], 'interventions': [{'name': 'Biological sampling', 'type': 'BIOLOGICAL', 'description': 'Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing', 'armGroupLabels': ['Patient with digestive neuroendocrine tumor']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'IRADJ SOBHANI, MD-PHD', 'role': 'CONTACT', 'email': 'iradj.sobhani@aphp.fr', 'phone': '01 49 81 23 62', 'phoneExt': '0033'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data are own by Assistance Publique - Hopitaux de Paris, please contact sponsor for further information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}