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

NCT04807868 | Recruiting

• 1 other identifier: 1628655
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

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

Keywords

NAFLD

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (2)

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

  Baseline with annual follow up for up to 5 years

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

  Baseline with annual follow up for up to 5 years

Study Arms (2)

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

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.

Biopsy Group

Fibroscan OTHER

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

Biopsy Group; Non-Biopsy Group

Biospecimen Collection OTHER

Blood and urine will be collected.

Biopsy Group; Non-Biopsy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead
• BPGbio: collaborator

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

RECRUITING

Related Links

• Website for AdventHealth Translational Research Institute

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue, fasting blood and spot urine will be collected

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Karen Corbin, PhD, RD

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Department

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: April 22, 2021
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)