An interventional study of ELF Test in Fatty Liver and NAFLD, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Screening
Background: During the hepatology evaluation, vibration-controlled transient elastography (VCTE) is often used as a clinical decision aid to target high-risk patients for liver biopsy. The enhanced liver fibrosis (ELF) test is expected to be approved in the US. We tested the hypothesis that making the ELF results available to the treating hepatologist will result in more appropriate and targeted use of liver biopsy in patients with elevated liver enzymes or fatty liver, and will result in more cases of advanced fibrosis/cirrhosis being diagnosed. Methods: During the hepatology evaluation for elevated liver enzymes or fatty liver at the University of Kansas Medical Center, the hepatologists (8 total) make a clinical decision on whether patients shall receive VCTE. At the end of the clinic visit, patients were enrolled and randomized to receiving an ELF test. Patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. The primary outcome is the rate of a diagnosis of F3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis with the initiation of hepatocellular carcinoma surveillance. Four hundred fifty patients are to be enrolled over two years.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 450 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive ELF testing (a blood draw) and their hepatologist receives the result within a week.
Diagnostic Test: ELF Test
No intervention.
Patients receive ELF testing (a blood draw) and their hepatologist receives the result within a week.
A diagnosis of F3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis.
The number of patients diagnosed with stage 3-4 based on liver biopsy or clinical diagnosis of cirrhosis in each arm of the study. Clinical diagnosis of cirrhosis is defined as provider diagnosing cirrhosis and ordering of hepatocellular carcinoma surveillance.
Time frame: 2 years
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center