Biobank and registry for non-alcoholic fatty liver disease
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
This study is collecting liver tissue, blood, and urine samples from people with non-alcoholic fatty liver disease and those at risk to help find better treatments and understand the disease better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth Translational Research Institute Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT04807868 on ClinicalTrials.gov |
What this trial studies
This study aims to create a biobank and registry to support research on non-alcoholic fatty liver disease (NAFLD). It will collect liver tissue samples during standard care biopsies, along with paired blood and urine samples, and relevant data such as FibroScan results. The goal is to advance the discovery of new therapies and improve risk stratification for patients at high risk for NAFLD. Participants will include both those undergoing liver biopsies and those with elevated BMI but without NAFLD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older scheduled for a liver biopsy or those with a BMI of 25 or higher without NAFLD.
Not a fit: Patients who are pregnant or have conditions that compromise their safety or data integrity will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapies and interventions for patients at risk of non-alcoholic fatty liver disease.
How similar studies have performed: Other studies have shown success in utilizing biobanks for advancing research in liver diseases, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orlando, Florida
- AdventHealth Translational Research Institute — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Karen Corbin, PhD, RD — Investigator
- Study coordinator: Recruitment Department
- Email: Fh.tri.recruitment@adventhealth.com
- Phone: 407-303-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.