Non-Alcoholic Fatty Liver DiseaseAVAILNCT04807868
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
An observational study of Non-Alcoholic Fatty Liver Disease, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Fibroscan and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to Mar 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with Non-alcoholic fatty liver disease (NAFLD) and adults without any history of NAFLD.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Recruitment Department, 407-303-7100, Fh.tri.recruitment@adventhealth.com
About this study
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Standard of care liver biopsy, Fibroscan, Biospecimen Collection
- Keywords
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care liver biopsyProcedure or surgery
Patients undergoing a standard of care liver biopsy for any reason who are willing to participate will be consented for collecting additional biopsy tissue for research purposes. 1-2 additional biopsy tissue cores will be collected for research. Liver tissue will be biobanked for future use.
FibroscanOther
A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.
Biospecimen CollectionOther
Blood and urine will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Biopsy Group | Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason Receives: Procedure: Standard of care liver biopsy; Other: Fibroscan; Other: Biospecimen Collection | |
| Non-Biopsy Group | Adults without any history of NAFLD Receives: Other: Fibroscan; Other: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata
Measured: Baseline
Secondary outcomes (2)
Creation of a Biobank of Blood and Urine Samples Paired with a Registry of Associated Histological and Clinical Metadata
Measured: Baseline with annual follow up for up to 5 years
Change in Liver Fat and Fibrosis Over Time ad Measured with FibroScan Controlled Attenuation Parameter and Vibration Controlled Transient Elastography, respectively
Measured: Baseline with annual follow up for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start22 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BPGbio
- Responsible party
- Sponsor
- Investigators
- Karen Corbin, PhD, RD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807868
- Sponsor's protocol ID
- 1628655
- Acronym
- AVAIL
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
- ClinicalTrials.gov ID
- NCT04807868
- Acronym / sponsor ID
- AVAIL / 1628655
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- BPGbio
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopsy Group | – | Procedure: Standard of care liver biopsy, Other: Fibroscan, Other: Biospecimen CollectionAdults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason |
| Non-Biopsy Group | – | Other: Fibroscan, Other: Biospecimen CollectionAdults without any history of NAFLD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Non-alcoholic fatty liver disease (NAFLD) and adults without any history of NAFLD.
Key inclusion criteria (6 listed)
- Females and Males ≥ 18 years of age.
- Understands the procedures and agrees to participate by giving written informed consent.
- Scheduled for standard of care liver biopsy for any reason.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care liver biopsyPatients undergoing a standard of care liver biopsy for any reason who are willing to participate will be consented for collecting additional biopsy tissue for research purposes. 1-2 additional biopsy tissue cores will be collected for research. Liver tissue will be biobanked for future use. | Procedure or surgery | Biopsy Group |
| FibroscanA FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis. | Other | Biopsy Group, Non-Biopsy Group |
| Biospecimen CollectionBlood and urine will be collected. | Other | Biopsy Group, Non-Biopsy Group |
Primary outcome
Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata
Time frame: Baseline
2 secondary outcomes
Creation of a Biobank of Blood and Urine Samples Paired with a Registry of Associated Histological and Clinical Metadata
Time frame: Baseline with annual follow up for up to 5 years
Change in Liver Fat and Fibrosis Over Time ad Measured with FibroScan Controlled Attenuation Parameter and Vibration Controlled Transient Elastography, respectively
Time frame: Baseline with annual follow up for up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Website for AdventHealth Translational Research InstituteLink provided by the sponsor.
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Corbin, PhD, RD principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Department (407-303-7100, Fh.tri.recruitment@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a Biobank of Liver Tissue Paired with a Registry of Histological and Clinical Metadata (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.