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RecruitingNCT04807868AVAILUpdated Mar 13, 2025

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

An observational study in Non-Alcoholic Fatty Liver Disease, sponsored by AdventHealth Translational Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by AdventHealth Translational Research Institute · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,250
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Non-Alcoholic Fatty Liver Disease

Keywords

  • NAFLD
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 1,250 is above the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

AdventHealth Translational Research Institute is the lead sponsor of 57 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults with Non-alcoholic fatty liver disease (NAFLD) and adults without any history of NAFLD.

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

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.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,250 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Biopsy Group

    Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason

    Procedure: Standard of care liver biopsy · Other: Fibroscan · Other: Biospecimen Collection

  • Non-Biopsy Group

    Adults without any history of NAFLD

    Other: Fibroscan · Other: Biospecimen Collection

Interventions

  • ProcedureStandard of care liver biopsy

    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.

  • OtherFibroscan

    A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.

  • OtherBiospecimen Collection

    Blood and urine will be collected.

06

What researchers measure

Primary outcomes

  1. Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata

    Time frame: Baseline

Secondary outcomes

  1. Creation of a Biobank of Blood and Urine Samples Paired with a Registry of Associated Histological and Clinical Metadata

    Time frame: Baseline with annual follow up for up to 5 years

  2. Change in Liver Fat and Fibrosis Over Time ad Measured with FibroScan Controlled Attenuation Parameter and Vibration Controlled Transient Elastography, respectively

    Time frame: Baseline with annual follow up for up to 5 years

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Study locations

1 of 1 sites recruiting
  • AdventHealth Translational Research Institute
    Orlando, Florida 32804, United States
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04807868
Lead sponsor
AdventHealth Translational Research Institute
Collaborators
BPGbio
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Apr 22, 2021
Primary completion
Dec 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Mar 13, 2025

Study contacts

Recruitment Department
Contact
Fh.tri.recruitment@adventhealth.com
407-303-7100
Karen Corbin, PhD, RD
principal investigator · Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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