Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-04-14 @ 10:31 PM
Study NCT ID:
NCT03293758
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food and Microbiome Longitudinal Investigation (FAMiLI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic', 'timeFrame': '5 Years', 'description': 'sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases.'}], 'secondaryOutcomes': [{'measure': 'Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without.', 'timeFrame': '5 Years', 'description': 'Pairwise alignment and clustering of sequences into operational taxonomic units (OTUs)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects in the United States identified at NYU clinics, community organizations, and online participant databases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 40\n\nExclusion Criteria:\n\n* Use of long term antibiotics.\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03293758', 'briefTitle': 'Food and Microbiome Longitudinal Investigation (FAMiLI)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Food and Microbiome Longitudinal Investigation (FAMiLI)', 'orgStudyIdInfo': {'id': '12-00855'}, 'secondaryIdInfos': [{'id': 'R21CA183887', 'link': 'https://reporter.nih.gov/quickSearch/R21CA183887', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dia Beggs', 'role': 'CONTACT', 'email': 'dia.beggs@nyulangone.org', 'phone': '646-501-3396'}, {'name': 'Jiyoung Ahn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Sukhleen Bedi', 'role': 'CONTACT', 'email': 'sukhleen.bedi@nyulangone.org', 'phone': '646-501-3396'}, {'name': 'Jiyoung Ahn, PhD', 'role': 'CONTACT', 'email': 'jiyoung.ahn@nyulangone.org', 'phone': '646-501-3373'}], 'overallOfficials': [{'name': 'Jiyoung Ahn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}