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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Procedure: Standard of care liver biopsy
* Other: Fibroscan
* Other: Biospecimen Collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biopsy Group<br>Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason | Procedure: Standard of care liver biopsy<br>* 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.<br>Other: Fibroscan<br>* A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.<br>Other: Biospecimen Collection<br>* Blood and urine will be collected.<br>|
| Non-Biopsy Group<br>Adults without any history of NAFLD | Other: Fibroscan<br>* A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.<br>Other: Biospecimen Collection<br>* Blood and urine will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD