AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Procedure: Standard of care liver biopsy; Other: Fibroscan; Other: Biospecimen Collection

• Registration Number: NCT04807868
• Lead Sponsor: AdventHealth Translational Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Study Start: 2021-04-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biopsy Group	Fibroscan	Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason
Biopsy Group	Biospecimen Collection	Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason
Non-Biopsy Group	Biospecimen Collection	Adults without any history of NAFLD
Non-Biopsy Group	Fibroscan	Adults without any history of NAFLD
Biopsy Group	Standard of care liver biopsy	Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason

Primary Outcome Measures

Name	Time	Method
Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata	Baseline

Secondary Outcome Measures

Name	Time	Method
Creation of a Biobank of Blood and Urine Samples Paired with a Registry of Associated Histological and Clinical Metadata	Baseline with annual follow up for up to 5 years
Change in Liver Fat and Fibrosis Over Time ad Measured with FibroScan Controlled Attenuation Parameter and Vibration Controlled Transient Elastography, respectively	Baseline with annual follow up for up to 5 years

Trial Locations

Locations (1)

AdventHealth Translational Research Institute; 🇺🇸 Orlando, Florida, United States