Fatty LiverNCT06225193
Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population
An observational study of Fatty Liver, run by Methodist Health System at 1 site in United States.
Trial summary
In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 23 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with 18 years of age, NAFLD/NASH and non-NAFLD/NASH who have assessed with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
Who may be able to join
- Age: ≥ 18 years
- NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
Who cannot join
- Patients with incomplete data and those lost to follow up.
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
Methodist Dallas Medical Center
Dallas, Texas, 75203
Jennifer N Kirchner, 214-947-1280 ext. 74459, jenniferkirchner@mhd.com
Colette Ngo Ndjom, MS, 217-947-4681 ext. 74459, mhsirb@mhd.com
About this study
In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score >7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.
Read the detailed description
Methodist Health System consists of nine hospitals and over one hundred clinics that serve 7% to 10% of patients in the Dallas metropolitan. In November 2021, adopted the use of ELF tests in patients who had risk factors for NAFLD/NASH based on abnormal liver enzymes, metabolic risk factors, and evidence of hepatosteatosis on imaging. There is a knowledge gap in the literature when it comes to ELF scores in our population and the data we collect in this study will contribute to filling that knowledge gap.
Historically, assessment of fibrosis has been accomplished with FibroScan,elastography or liver biopsy. However, these tests are not widely available in most clinics, and can be invasive and costly. At present, the two primary inexpensive and non-invasive alternatives are the fibrosis-4 (FIB-4) and ELF scores, which employ algorithms that utilize routine lab draws. While a low FIB-4 score has a negative predictive value of 90% for advanced fibrosis, it does not provide a risk assessment of liver-related events. For this reason, the study explore the newer ELF serum test as a non-invasive, more affordable and available means to detect patients with developing fibrosis and as a predictor of liver-related outcomes that could be easily used in a primary care setting. This will better risk-stratify this patient population at the primary care level, without need for invasive and expensive testing, and will guide appropriate referrals to Hepatology.
- Conditions
- Fatty Liver
- Medical subject headings
- Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced Liver Fibrosis (ELF )scores
Will measure the ELF scores-Reference range 7.14-9.55, the lowest value means better and highest value would mean worst
Measured: 6 months
Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy
Number of hospital admissions for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy
Measured: 6 months
Demographics
age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)
Measured: 6 months
Instances of comorbidities
Patients with hypertension(HTN), Hypersensitivity Lung Disease(HLD), Coronary Artery Disease(CAD),Heart Failure( HF), Atherosclerotic cardiovascular disease (ASCVD), Type 2 Diabetes Mellitus(T2DM) as comorbidities
Measured: 6 months
Secondary outcomes (2)
Abnormalities in Liver ultrasound (U/S) findings
rate of liver damage
Measured: 6 months
Abnormalities in Liver biopsy results
Rate of cancerous cells in liver
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start20 Jun 2023
- Primary completion23 Jun 2026 (estimated)
- Study completion23 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parvez Mantry, MD, Principal investigator, Methodist Midlothian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225193
- Sponsor's protocol ID
- 022.HEP.2023.D
- Status last verified
- May 2026
- First submitted
- 13 Nov 2023
- Last updated
- 13 May 2026
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population
- ClinicalTrials.gov ID
- NCT06225193
- Acronym / sponsor ID
- 022.HEP.2023.D
- Conditions
- Fatty Liver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 23 Jun 2026 (estimated)
- Study completion
- 23 Jun 2026 (estimated)
- First posted
- 25 Jan 2024 (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.
In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score >7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.
Detailed description
Methodist Health System consists of nine hospitals and over one hundred clinics that serve 7% to 10% of patients in the Dallas metropolitan. In November 2021, adopted the use of ELF tests in patients who had risk factors for NAFLD/NASH based on abnormal liver enzymes, metabolic risk factors, and evidence of hepatosteatosis on imaging. There is a knowledge gap in the literature when it comes to ELF scores in our population and the data we collect in this study will contribute to filling that knowledge gap.
Historically, assessment of fibrosis has been accomplished with FibroScan,elastography or liver biopsy. However, these tests are not widely available in most clinics, and can be invasive and costly. At present, the two primary inexpensive and non-invasive alternatives are the fibrosis-4 (FIB-4) and ELF scores, which employ algorithms that utilize routine lab draws. While a low FIB-4 score has a negative predictive value of 90% for advanced fibrosis, it does not provide a risk assessment of liver-related events. For this reason, the study explore the newer ELF serum test as a non-invasive, more affordable and available means to detect patients with developing fibrosis and as a predictor of liver-related outcomes that could be easily used in a primary care setting. This will better risk-stratify this patient population at the primary care level, without need for invasive and expensive testing, and will guide appropriate referrals to Hepatology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 18 years of age, NAFLD/NASH and non-NAFLD/NASH who have assessed with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
Key inclusion criteria (2 listed)
- Age: ≥ 18 years
- NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
Key exclusion criteria (1 listed)
- Patients with incomplete data and those lost to follow up.
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
Enhanced Liver Fibrosis (ELF )scores
Time frame: 6 months
Will measure the ELF scores-Reference range 7.14-9.55, the lowest value means better and highest value would mean worst
Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy
Time frame: 6 months
Number of hospital admissions for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy
Demographics
Time frame: 6 months
age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)
Instances of comorbidities
Time frame: 6 months
Patients with hypertension(HTN), Hypersensitivity Lung Disease(HLD), Coronary Artery Disease(CAD),Heart Failure( HF), Atherosclerotic cardiovascular disease (ASCVD), Type 2 Diabetes Mellitus(T2DM) as comorbidities
2 secondary outcomes
Abnormalities in Liver ultrasound (U/S) findings
Time frame: 6 months
Abnormalities in Liver biopsy results
Time frame: 6 months
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 May 2026.
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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.
Parvez Mantry, MD principal investigator
Methodist Midlothian 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 Fatty Liver, run by Methodist Health System 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 2 inclusion and 1 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 May 2026. 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 Crystee Cooper (2149471280, crysteecooper@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced Liver Fibrosis (ELF )scores (time frame: 6 months). The study lists 4 primary outcomes in all. 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 May 2026.