Clinical trial NCT04807868: AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Official title: AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: NAFLD
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: BPGbio
First posted: 2021-03-19
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Non-alcoholic fatty liver disease (NAFLD) and adults without any history of NAFLD.

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.

Primary outcomes:
measure: Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata
timeFrame: Baseline
Secondary outcomes:
measure: Creation of a Biobank of Blood and Urine Samples Paired with a Registry of Associated Histological and Clinical Metadata
timeFrame: Baseline with annual follow up for up to 5 years
measure: Change in Liver Fat and Fibrosis Over Time ad Measured with FibroScan Controlled Attenuation Parameter and Vibration Controlled Transient Elastography, respectively
timeFrame: Baseline with annual follow up for up to 5 years
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
Study officials:
affiliation: Investigator
name: Karen Corbin, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: