AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of care liver biopsy, Fibroscan, Biospecimen Collection.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - Other Biospecimen Collection
Blood and urine will be collected.
Primary outcome measures
- Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata [Time frame: Baseline]
Secondary outcome measures (2)
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- AdventHealth Translational Research Institute — Orlando
Identifiers
NCT: NCT04807868 · 1628655