NCT04807868RecruitingNot Applicable
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
AdventHealth Translational Research Institute1 site in 1 country1,250 target enrollmentStarted: April 22, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,250
- Locations
- 1
- Primary Endpoint
- Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata
Time Frame: Baseline
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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