Actively Recruiting
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Led by AdventHealth Translational Research Institute · Updated on 2025-03-13
1250
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
A
AdventHealth Translational Research Institute
Lead Sponsor
B
BPGbio
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are creating a biobank and registry focused on non-alcoholic fatty liver disease (NAFLD) to help discover new treatments, improve risk assessment, and guide interventions for those at highest risk. This observational study collects liver tissue, blood, urine, and clinical data from adults undergoing standard liver biopsies as well as adults without NAFLD. The goal is to support future research by providing paired biological samples and detailed medical information. Participants include adults scheduled for routine liver biopsies and adults with a body mass index of 25 or higher, with or without type 2 diabetes, but no current NAFLD diagnosis. During the study, additional liver tissue samples will be collected during biopsies for research. Blood and urine samples will also be collected, and a FibroScan will be performed to monitor liver fat and fibrosis over time. Data collection includes baseline and annual follow-ups for up to five years. Participants will be involved in sample collection and undergo FibroScan assessments. Researchers will gather clinical data, histological information, and track changes in liver fat and fibrosis. Safety and data integrity are monitored throughout. The study aims to build a comprehensive resource of biological samples and clinical metadata to facilitate future NAFLD research and improve understanding of disease progression.
CONDITIONS
Brief Title
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females and males 18 years of age or older
- Understands the procedures and agrees to participate by giving written informed consent
- Scheduled for standard of care liver biopsy for any reason (Biopsy Group only)
- BMI of 25 or higher, with or without type 2 diabetes, without any level of NAFLD based on recent medical history or prior study data (Non-Biopsy Group only)
You will not qualify if you...
- Pregnant women referred for a liver biopsy
- Any condition that compromises participant safety, data integrity, or ability to complete the study as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo a standard of care liver biopsy or assessments to evaluate liver health, including FibroScan and biospecimen collection.
1 to 2 visits depending on biopsy group assignment
Duration - Up to 5 years
Participants have annual follow-up visits to monitor liver fat and fibrosis using FibroScan and provide blood and urine samples for up to 5 years.
Annual visits for up to 5 years
Trial Site Locations
Total: 1 location
1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804
Actively Recruiting
Research Team
R
Recruitment Department
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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