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NCT Number: NCT04807868

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

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.

Recruiting

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location status: Recruiting

Location contact

Recruitment Department

CONTACT

[email protected]

407-303-7100

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care liver biopsy

Procedure

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.

Fibroscan

Other

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

Biospecimen Collection

Other

Blood and urine will be collected.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Recruitment Department

CONTACT

[email protected]

407-303-7100

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

  • BPGbio

Registry information

Acronym: AVAIL

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 19, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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