NCT04807868 AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
| NCT ID | NCT04807868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AdventHealth Translational Research Institute |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2021-04-22 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,250 participants in total. It began in 2021-04-22 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Karen Corbin, PhD, RD
PRINCIPAL INVESTIGATOR
Investigator
Frequently Asked Questions
Who can join the NCT04807868 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04807868 currently recruiting?
Yes, NCT04807868 is actively recruiting participants. Contact the research team at Fh.tri.recruitment@adventhealth.com for enrollment information.
Where is the NCT04807868 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT04807868 clinical trial?
NCT04807868 is sponsored by AdventHealth Translational Research Institute. The principal investigator is Karen Corbin, PhD, RD at Investigator. The trial plans to enroll 1,250 participants.