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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— AVAIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04807868
• Other study ID #: 1628655
• Status: Recruiting
• Start date: April 22, 2021
• Est. completion date: March 2026

Study information

• Verified date: June 2024
• Source: AdventHealth Translational Research Institute
• Contact: Recruitment Department
• Phone: 407-303-7100
• Email: Fh.tri.recruitment[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: March 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Procedure:
• 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.

Other:
• Fibroscan
A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.
• Biospecimen Collection
Blood and urine will be collected.

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute	Berg, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata		Baseline
Secondary	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
Secondary	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

External Links

•   Website for AdventHealth Translational Research Institute