NAFLDSUNNNCT03726827
A Self Selected Population Study of Undiagnosed NAFLD and NASH, Using an Echosens FibroScan, in at Risk Populations
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by Fatty liver Foundation at 1 site in United States.
Trial summary
Liver disease (NAFLD) and (NASH) are a rapidly increasing population health threat driven primarily by diet and lifestyle. Fibrotic liver disease, culminating in cirrhosis, is frequently asymptomatic so it is common for a patient to first learn of what is a life threatening condition by being told that they have… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- What is being tested?
- Fibroscan screening
- How many people
- 1,006 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: General population on a self selected basis, however, recruitment efforts will be directed to the high risk population that is over 50 years old, obese, type 2 diabetic, or have other common co-morbid conditions
Who may be able to join
- self selected
Who cannot join
- Must be over 17 years old
- Cannot be pregnant
- Cannot have any implanted electronic devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Undiagnosed NAFLD and NASH
Liver disease (NAFLD) and (NASH) are a rapidly increasing population health threat driven primarily by diet and lifestyle. Fibrotic liver disease, culminating in cirrhosis, is frequently asymptomatic so it is common for a patient to first learn of what is a life threatening condition by being told that they have cirrhosis. Management and treatment of cirrhosis is complex and very costly with the only current cure being a very expensive transplant for end stage liver disease. The SUNN study seeks to perform Fibroscan wellness testing on at risk but asymptomatic self selected patients in the general population to identify disease early and to triage patients toward care or educational tools based upon test results. No personally identifiable information will be collected but demographic and test results will be imported into a registry for data analysis. Results of the study will guide development of screening protocols to identify early stage disease in a wellness screening model.
Read the detailed description
The standard of care published by the American Association for the Study of Liver Disease, (AASLD) do not recommend screening of asymptomatic patients for liver fibrosis so it is common that the first a patient learns of the disease is when they are diagnosed with cirrhosis. Detection at early stages of the disease process is mostly accidental as a result of other procedures.
Research has clearly established the health risks associated with liver disease and comorbidity with a wide range of other illnesses. FibroScan has been shown to be a useful test to identify asymptomatic liver disease.
The FibroScan device (Echosens) works by measuring shear wave velocity. In this technique, a 50 megahertz wave is passed into the liver from a small transducer on the end of an ultrasound probe. The probe also has a transducer on the end that can measure the velocity of the shear wave (in meters per second) as this wave passes through the liver. The shear wave velocity can then be converted into liver stiffness, which is expressed in kilopascals. Essentially, the technology measures the velocity of the sound wave passing through the liver and then converts that measurement into a liver stiffness measurement; the entire process is often referred to as liver ultrasonographic elastography. The procedure is non-invasive and presents no bio-chemical hazards as it uses only well understood ultrasound technology.
The goal of this screening study is to gather FibroScan data from the at-risk but undiagnosed population on a self-selection basis so that incidence rates can be calculated and the economics of a single function screening service can be evaluated.
The objective is to develop evidence based information to determine if noninvasive screening of at risk, comorbid people is feasible with this modality.
Furthermore, a secondary goal is to educate all participants about liver disease, lifestyle, healthy diets, organ donation, and clinical trials as part of the Foundation's larger mission of being patient advocates.
Questions Posed by this Study:
- What population demographics justify routine screening on a cost benefit basis?
- What operating cost burden is required to sustain a mobile screening project and what is the minimum utilization required to justify it?
- What portion of the asymptomatic patient with advanced disease will be willing to learn about clinical trials?
All patients will receive education about liver disease as part of the intake process. From the patient perspective, the key result will be that they receive the printed output from their FibroScan test. Interpretation of that result requires expert support. The investigators will direct patients to local medical resources where their questions can be answered, but the ideal route will be a triage through telemedicine with a hepatologist as a way to quickly direct them to proper resources. Patients with test results indicating no active disease will be offered connections to nutrition and dietary support. In all cases patients will be offered enrollment in online educational tools.
- Being tested
- Fibroscan screening
- Keywords
- NAFLD, NASH, cirrhosis, fatty liver, incidence, fibroscan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan screeningOther
A single Fibroscan screening for fat content and liver stiffness
| Study group | Role | What they receive |
|---|---|---|
| population | self selected members of the general population who perceive a value in having a Fibroscan screening test of their liver Receives: Other: Fibroscan screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the frequency distribution and severity of steatosis stage (S0, S1, S2, S3) and liver fibrosis stage (F0, F1, F2, F3, F4) in the test population.
The frequency distribution is the percentage each stage represents of the total. Severity is described by the disease staging. Staging is not measured directly so test scores are normalized to a stage using cutoff values. The results are fat content (steatosis) and liver fibrosis (steatohepatitis) derived from test measurements of CAP score (controlled attenuation parameter) and LSM (liver stiffness measure). These are used to calculate the frequency distribution and staging of steatosis stage (S0, S1, S2, S3) and liver fibrosis stage (F0, F1, F2, F3, F4). The resulting dataset will then be assigned to a disease stage according to the breakpoints below.
CAP S0 (<225) S1 (225-275), S2 (276-300), S3 (>300)
LSM F0 (<7.0) F1 (7.0-7.4) F2 (7.5-9.9) F3 (10.0-13.9) F4 (>13.9)
The distribution of the normalized dataset will be calculated as the percentage each bracket is of the total number of tests in that subset.
Measured: The test period will be six months and results will be reported 3 months after end of testing.
Secondary outcomes (1)
Calculate the frequency distribution and severity of steatosis and liver fibrosis in the test population by ethnicity.
Repeat the analysis by ethnicity
Measured: The test period will be six months and results will be reported 3 months after end of testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Other
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatty liver Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne Eskridge, BS, Principal investigator, Fatty liver Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726827
- Sponsor's protocol ID
- flf-screen 1
- Acronym
- SUNN
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No personally identifiable information will be collected but the population data will be made available to other researchers though the method has not yet been determined
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Undiagnosed NAFLD and NASH
- ClinicalTrials.gov ID
- NCT03726827
- Acronym / sponsor ID
- SUNN / flf-screen 1
- Keywords
- NAFLD, NASH, cirrhosis, fatty liver, incidence, fibroscan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Fatty liver FoundationUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 1 Nov 2018 (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.
Liver disease (NAFLD) and (NASH) are a rapidly increasing population health threat driven primarily by diet and lifestyle. Fibrotic liver disease, culminating in cirrhosis, is frequently asymptomatic so it is common for a patient to first learn of what is a life threatening condition by being told that they have cirrhosis. Management and treatment of cirrhosis is complex and very costly with the only current cure being a very expensive transplant for end stage liver disease. The SUNN study seeks to perform Fibroscan wellness testing on at risk but asymptomatic self selected patients in the general population to identify disease early and to triage patients toward care or educational tools based upon test results. No personally identifiable information will be collected but demographic and test results will be imported into a registry for data analysis. Results of the study will guide development of screening protocols to identify early stage disease in a wellness screening model.
Detailed description
The standard of care published by the American Association for the Study of Liver Disease, (AASLD) do not recommend screening of asymptomatic patients for liver fibrosis so it is common that the first a patient learns of the disease is when they are diagnosed with cirrhosis. Detection at early stages of the disease process is mostly accidental as a result of other procedures.
Research has clearly established the health risks associated with liver disease and comorbidity with a wide range of other illnesses. FibroScan has been shown to be a useful test to identify asymptomatic liver disease.
The FibroScan device (Echosens) works by measuring shear wave velocity. In this technique, a 50 megahertz wave is passed into the liver from a small transducer on the end of an ultrasound probe. The probe also has a transducer on the end that can measure the velocity of the shear wave (in meters per second) as this wave passes through the liver. The shear wave velocity can then be converted into liver stiffness, which is expressed in kilopascals. Essentially, the technology measures the velocity of the sound wave passing through the liver and then converts that measurement into a liver stiffness measurement; the entire process is often referred to as liver ultrasonographic elastography. The procedure is non-invasive and presents no bio-chemical hazards as it uses only well understood ultrasound technology.
The goal of this screening study is to gather FibroScan data from the at-risk but undiagnosed population on a self-selection basis so that incidence rates can be calculated and the economics of a single function screening service can be evaluated.
The objective is to develop evidence based information to determine if noninvasive screening of at risk, comorbid people is feasible with this modality.
Furthermore, a secondary goal is to educate all participants about liver disease, lifestyle, healthy diets, organ donation, and clinical trials as part of the Foundation's larger mission of being patient advocates.
Questions Posed by this Study:
- What population demographics justify routine screening on a cost benefit basis?
- What operating cost burden is required to sustain a mobile screening project and what is the minimum utilization required to justify it?
- What portion of the asymptomatic patient with advanced disease will be willing to learn about clinical trials?
All patients will receive education about liver disease as part of the intake process. From the patient perspective, the key result will be that they receive the printed output from their FibroScan test. Interpretation of that result requires expert support. The investigators will direct patients to local medical resources where their questions can be answered, but the ideal route will be a triage through telemedicine with a hepatologist as a way to quickly direct them to proper resources. Patients with test results indicating no active disease will be offered connections to nutrition and dietary support. In all cases patients will be offered enrollment in online educational tools.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| population | – | Other: Fibroscan screeningself selected members of the general population who perceive a value in having a Fibroscan screening test of their liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population on a self selected basis, however, recruitment efforts will be directed to the high risk population that is over 50 years old, obese, type 2 diabetic, or have other common co-morbid conditions
Key inclusion criteria (1 listed)
- self selected
Key exclusion criteria (3 listed)
- Must be over 17 years old
- Cannot be pregnant
- Cannot have any implanted electronic devices
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 |
|---|---|---|
| Fibroscan screeningA single Fibroscan screening for fat content and liver stiffness | Other | population |
Primary outcome
Calculate the frequency distribution and severity of steatosis stage (S0, S1, S2, S3) and liver fibrosis stage (F0, F1, F2, F3, F4) in the test population.
Time frame: The test period will be six months and results will be reported 3 months after end of testing.
The frequency distribution is the percentage each stage represents of the total. Severity is described by the disease staging. Staging is not measured directly so test scores are normalized to a stage using cutoff values. The results are fat content (steatosis) and liver fibrosis (steatohepatitis) derived from test measurements of CAP score (controlled attenuation parameter) and LSM (liver stiffness measure). These are used to calculate the frequency distribution and staging of steatosis stage (S0, S1, S2, S3) and liver fibrosis stage (F0, F1, F2, F3, F4). The resulting dataset will then be assigned to a disease stage according to the breakpoints below. CAP S0 (<225) S1 (225-275), S2 (276-300), S3 (>300) LSM F0 (<7.0) F1 (7.0-7.4) F2 (7.5-9.9) F3 (10.0-13.9) F4 (>13.9) The distribution of the normalized dataset will be calculated as the percentage each bracket is of the total number of tests in that subset.
1 secondary outcome
Calculate the frequency distribution and severity of steatosis and liver fibrosis in the test population by ethnicity.
Time frame: The test period will be six months and results will be reported 3 months after end of testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: Undecided. No personally identifiable information will be collected but the population data will be made available to other researchers though the method has not yet been determined
Related trials for NAFLD
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Recruiting
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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. This study is not recruiting at the moment.
Wayne Eskridge, BS principal investigator
Fatty liver Foundation
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 NAFLD and NASH - Nonalcoholic Steatohepatitis, run by Fatty liver Foundation 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 1 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: finished, as of the sponsor's last update on 23 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the frequency distribution and severity of steatosis stage (S0, S1, S2, S3) and liver fibrosis stage (F0, F1, F2, F3, F4) in the test population. (time frame: The test period will be six months and results will be reported 3 months after end of testing.). 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 23 Sep 2019.