Status:
RECRUITING
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Lead Sponsor:
AdventHealth Translational Research Institute
Collaborating Sponsors:
BPGbio
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
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 ris...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT04807868
Start Date
April 22 2021
End Date
March 1 2026
Last Update
March 13 2025
Active Locations (1)
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1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804