NCT04807868Recruiting
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1250 (estimated)
- First submitted
- 16 Mar 2021
- Start date
- 22 Apr 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- AdventHealth Translational Research Institute
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04807868
What you commit to
- Study type: Observational
- Planned participants: 1250
- From 22 Apr 2021 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Women who are pregnant when referred for a liver biopsy will be excluded.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AdventHealth Translational Research Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.