Recruiting

Observational Study

Sponsor:

AdventHealth Translational Research Institute

Code:

NCT04807868

Conditions

Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Standard of care liver biopsy

Fibroscan

Biospecimen Collection

Study Details

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study ID

NCT04807868

Start date

Apr 22, 2021

Status verified date

Mar, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

1250 participants

Anticipated

Interventions and Outcome Measures

Arms

Biopsy Group

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

Non-Biopsy Group

Adults without any history of NAFLD

Interventions

Standard 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.

Fibroscan

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

Biospecimen Collection

Blood and urine will be collected.

Primary outcome measure

  • Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Recruitment Department

407-303-7100Fh.tri.recruitment@adventhealth.com

Locations

AdventHealth Translational Research Institute

Recruiting

Orlando, Florida, United States, 32804

Contacts

Recruitment Department

407-303-7100Fh.tri.recruitment@adventhealth.com

More Information

Sponsor

AdventHealth Translational Research Institute

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Keywords

  • NAFLD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth Translational Research Institute on 2025-03-13.