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

Last updated: March 12, 2025
Sponsor: AdventHealth Translational Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Liver Disease

Treatment

Standard of care liver biopsy

Fibroscan

Biospecimen Collection

Clinical Study ID

NCT04807868
1628655
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Females and Males ≥ 18 years of age.

  • Understands the procedures and agrees to participate by giving written informed consent.

Biopsy Group Only:

• Scheduled for standard of care liver biopsy for any reason.

Non-Biopsy Group Only:

• 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.

Exclusion Criteria

  • Women who are pregnant when referred for a liver biopsy will be excluded.

  • 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.

Otherwise, 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.

Study Design

Total Participants: 1250
Treatment Group(s): 3
Primary Treatment: Standard of care liver biopsy
Phase:
Study Start date:
April 22, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • AdventHealth Translational Research Institute

    Orlando, Florida 32804
    United States

    Active - Recruiting

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