Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-04 @ 2:43 AM
Study NCT ID:
NCT04807868
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Liver tissue, fasting blood and spot urine will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1250}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Creation of a Biobank of Blood and Urine Samples Paired with a Registry of Associated Histological and Clinical Metadata', 'timeFrame': 'Baseline with annual follow up for up to 5 years'}, {'measure': 'Change in Liver Fat and Fibrosis Over Time ad Measured with FibroScan Controlled Attenuation Parameter and Vibration Controlled Transient Elastography, respectively', 'timeFrame': 'Baseline with annual follow up for up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAFLD'], 'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.adventhealthresearchinstitute.com/research/translational-research', 'label': 'Website for AdventHealth Translational Research Institute'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a resource that will advance research that is focused on discovery of novel therapies, risk stratification, and aggressive interventions for those at highest risk for non-alcoholic fatty liver disease (NAFLD). To achieve this, we will generate a biobank of liver tissue collected during standard of care liver biopsies. Paired blood/urine samples, FibroScan and relevant data will also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with Non-alcoholic fatty liver disease (NAFLD) and adults without any history of NAFLD.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Females and Males ≥ 18 years of age.\n* Understands the procedures and agrees to participate by giving written informed consent.\n\nBiopsy Group Only:\n\n• Scheduled for standard of care liver biopsy for any reason.\n\nNon-Biopsy Group Only:\n\n• BMI ≥ 25, with or without type 2 diabetes, without any level of NAFLD based on: (1) Recent medical history (within 6 months of screening visit). (2) Data collected from participation in a prior research study where they consented to be re-contacted for future studies.\n\nExclusion Criteria\n\n* Women who are pregnant when referred for a liver biopsy will be excluded.\n* Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.\n\nOtherwise, all eligible patients who consent will be included in AVAIL. If participants in the non-biopsy group are found to have NAFLD based on the FibroScan done for this study, then they will be informed of this and advised to follow up with their physician. Their data will still be part of the registry and analyzed with the biopsy group that is found to have NAFLD."}, 'identificationModule': {'nctId': 'NCT04807868', 'acronym': 'AVAIL', 'briefTitle': 'AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth Translational Research Institute'}, 'officialTitle': 'AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)', 'orgStudyIdInfo': {'id': '1628655'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biopsy Group', 'description': 'Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason', 'interventionNames': ['Procedure: Standard of care liver biopsy', 'Other: Fibroscan', 'Other: Biospecimen Collection']}, {'label': 'Non-Biopsy Group', 'description': 'Adults without any history of NAFLD', 'interventionNames': ['Other: Fibroscan', 'Other: Biospecimen Collection']}], 'interventions': [{'name': 'Standard of care liver biopsy', 'type': 'PROCEDURE', 'description': 'Patients undergoing a standard of care liver biopsy for any reason who are willing to participate will be consented for collecting additional biopsy tissue for research purposes. 1-2 additional biopsy tissue cores will be collected for research. Liver tissue will be biobanked for future use.', 'armGroupLabels': ['Biopsy Group']}, {'name': 'Fibroscan', 'type': 'OTHER', 'description': 'A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.', 'armGroupLabels': ['Biopsy Group', 'Non-Biopsy Group']}, {'name': 'Biospecimen Collection', 'type': 'OTHER', 'description': 'Blood and urine will be collected.', 'armGroupLabels': ['Biopsy Group', 'Non-Biopsy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Recruitment Department', 'role': 'CONTACT', 'email': 'Fh.tri.recruitment@adventhealth.com', 'phone': '407-303-7100'}], 'facility': 'AdventHealth Translational Research Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Recruitment Department', 'role': 'CONTACT', 'email': 'Fh.tri.recruitment@adventhealth.com', 'phone': '407-303-7100'}], 'overallOfficials': [{'name': 'Karen Corbin, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth Translational Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'BPGbio', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}