Non-alcoholic Fatty Liver DiseaseNCT03608748
Early Detection of Advanced Fatty Liver Disease
An observational study of Non-alcoholic Fatty Liver Disease and Liver Fibrosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects. The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not… Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Liver Fibrosis
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 1 Mar 2023
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients aged 45-60 years old without known liver disease who belong to an initial clinic which was chosen arbitrarily.
Who may be able to join
- Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily.
- Subjects without known liver disease.
- Subjects agree to sign a consent form. -
Who cannot join
- History of right-sided heart failure
- History of liver disease including positive infectious serology for hepatitis B or C
- Pregnant women
- People incapable of judgment -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study: Early Detection of Advanced Fatty Liver Disease in the General Adult Population by Using Non-Alcoholic Fatty Liver Disease Score and Elastography
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects.
The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.
Read the detailed description
The investigators will run an algorithm for the non-invasive diagnosis of advanced fibrosis in non-alcoholic fatty liver disease on a participants without known liver disease.
Nafld Score and Elastography are now being used to predict the severity of liver fibrosis and deciding whether the patient is going to a biopsy, clinical follow-up or further investigation of liver cirrhosis and complications.
The detection of participants with Nafld Score more than 0.675 (advanced fibrosis) will enroll them to an elastography test. Participants with advanced fibrosis according to elastography will be introduced to follow-up and treatment that should delay or prevent progression of the disease to more advanced conditions like: cirrhosis, portal hypertension, esophageal varicose veins and hepatocellular carcinoma.
If the investigators find that the results of the study are consistent with their hypothesis, this will lead to applying the flowchart to a larger sample of population in order to use it as a future survey.
Moreover, the investigators will check whether there is a correlation between Nafld Score and elastography in participants without know liver disease with Nafld Score more than 0.675.
- Conditions
- Non-alcoholic Fatty Liver Disease, Liver Fibrosis
- Keywords
- Nafld Score, Elastography
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Alcoholic Fatty Liver Disease Score
Non-alcoholic fatty liver disease Score (Nafld Score) is a non-invasive scoring system based on several laboratory tests that helps to estimate the amount of scarring in the liver. The score is made up of six parameters: age, BMI(body mass index), aspartate aminotransferase(AST) / alanine transaminase(ALT), platelet count, impaired fasting glucose(IFG), albumin.
The Nafld Score formula is: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×10^9/l) - 0.66 × albumin (g/dl).
2 cutoff points were selected to identify the presence (> 0.675) and absence (< -1.455) of significant fibrosis.
< -1.455: predictor of absence of significant fibrosis (F0-F2 fibrosis), negative predictive value 93% .
between -1.455 and 0.675: indeterminate score.
>0.675: predictor of presence of significant fibrosis (F3-F4 fibrosis), positive predictive value of 90%.
The score will be calculated for all the participants.
Measured: Up to five minutes
Secondary outcomes (1)
Elastography Test
Ultrasound Elastography is a non-invasive test which uses the technology of Shear Wave Elastography (SWE) obtained from the right liver lobe for staging liver fibrosis according to Metavir Fibrosis Score with sensitivity between 86% -98% and specificity between 90% -93%.
Metavir Fibrosis Score is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy.
Liver fibrosis assessed by Shear Wave Elastography is well correlated to biopsy using Metavir Score.
Participants with Nafld Score above 0.675 will undergo ShearWave Elastography.
The outcome of the test will be correlated to Metavir Score system according to the chart below:
SWE (kiloPascal) , METAVIR score, Fibrosis Level.
Below 5 , F0 , No fibrosis.
5.0-7.1 , F1 , Mild Fibrosis.
7.1-8.7 , F2 , Significant Fibrosis.
8.7-10.4 , F3 , Sever Fibrosis.
10.4-19 , F4 , Cirrhosis.
Measured: Up to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawi Hazzan, HaEmek Medical Center, Israel
- Investigators
- Rawi Hazzan, Dr, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608748
- Sponsor's protocol ID
- 007-18-EMC
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2018
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study: Early Detection of Advanced Fatty Liver Disease in the General Adult Population by Using Non-Alcoholic Fatty Liver Disease Score and Elastography
- ClinicalTrials.gov ID
- NCT03608748
- Acronym / sponsor ID
- 007-18-EMC
- Conditions
- Non-alcoholic Fatty Liver Disease, Liver Fibrosis
- Keywords
- Nafld Score, Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Aug 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.
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects.
The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.
Detailed description
The investigators will run an algorithm for the non-invasive diagnosis of advanced fibrosis in non-alcoholic fatty liver disease on a participants without known liver disease.
Nafld Score and Elastography are now being used to predict the severity of liver fibrosis and deciding whether the patient is going to a biopsy, clinical follow-up or further investigation of liver cirrhosis and complications.
The detection of participants with Nafld Score more than 0.675 (advanced fibrosis) will enroll them to an elastography test. Participants with advanced fibrosis according to elastography will be introduced to follow-up and treatment that should delay or prevent progression of the disease to more advanced conditions like: cirrhosis, portal hypertension, esophageal varicose veins and hepatocellular carcinoma.
If the investigators find that the results of the study are consistent with their hypothesis, this will lead to applying the flowchart to a larger sample of population in order to use it as a future survey.
Moreover, the investigators will check whether there is a correlation between Nafld Score and elastography in participants without know liver disease with Nafld Score more than 0.675.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients aged 45-60 years old without known liver disease who belong to an initial clinic which was chosen arbitrarily.
Key inclusion criteria (3 listed)
- Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily.
- Subjects without known liver disease.
- Subjects agree to sign a consent form. -
Key exclusion criteria (4 listed)
- History of right-sided heart failure
- History of liver disease including positive infectious serology for hepatitis B or C
- Pregnant women
- People incapable of judgment -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-Alcoholic Fatty Liver Disease Score
Time frame: Up to five minutes
Non-alcoholic fatty liver disease Score (Nafld Score) is a non-invasive scoring system based on several laboratory tests that helps to estimate the amount of scarring in the liver. The score is made up of six parameters: age, BMI(body mass index), aspartate aminotransferase(AST) / alanine transaminase(ALT), platelet count, impaired fasting glucose(IFG), albumin. The Nafld Score formula is: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×10^9/l) - 0.66 × albumin (g/dl). 2 cutoff points were selected to identify the presence (> 0.675) and absence (< -1.455) of significant fibrosis. < -1.455: predictor of absence of significant fibrosis (F0-F2 fibrosis), negative predictive value 93% . between -1.455 and 0.675: indeterminate score. >0.675: predictor of presence of significant fibrosis (F3-F4 fibrosis), positive predictive value of 90%. The score will be calculated for all the participants.
1 secondary outcome
Elastography Test
Time frame: Up to two hours
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 29 Feb 2024.
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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.
Rawi Hazzan, Dr principal investigator
haemek medical center
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 and Liver Fibrosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 4 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 29 Feb 2024. 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 Israel. 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?
Non-Alcoholic Fatty Liver Disease Score (time frame: Up to five minutes). 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 29 Feb 2024.