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

ConditionNon-Alcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdventHealth Translational Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Females and Males ≥ 18 years of age.

Understands the procedures and agrees to participate by giving written informed consent.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Standard of care liver biopsy

    Procedure/Surgery

    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 intervention

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

  • Biospecimen Collection

    Other intervention

    Blood and urine will be collected.

Treatment groups

1,250 Participants
are divided into 2 treatment groups
Group A: Biopsy Group3 interventions
Group B: Non-Biopsy Group2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth Translational Research Institute

Lead sponsor

BPGbio

Collaborator

Source ClinicalTrials.gov
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