AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Recruiting · NCT04807868 · Observational (researchers observe without assigning treatment) · Lead sponsor: AdventHealth Translational Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionFibroscanStandard of care liver biopsy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
- therwise, 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.
Where it is running
1 location listed across 1 US state.
- AdventHealth Translational Research Institute - Orlando, Florida, United States