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NCT05370053 · ClinicalTrials.gov registry record · NA
The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) With Fibrosis in Patients Referred to Hepatology
A NA study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 450
- Enrollment target
NCT05370053: Completed NA study, sponsored by University of Kansas Medical Center.
NCT05370053 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 450 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05370053, a NA study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST ELF Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2022-12-01 |
| Phase | NA |
What the finished NCT05370053 record still lists
NCT05370053 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which ELF Test is the first listed.
NCT05370053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05370053 about?
NCT05370053 is a clinical study titled "The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) With Fibrosis in Patients Referred to Hepatology". 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 t...
What is the current status of trial NCT05370053?
This trial is currently completed. It is a NA study. The enrollment target is 450 participants. The study started on 2020-09-01. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT05370053?
The interventions under investigation include: ELF Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05370053?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05370053's enrollment target sits among peer trials
450 225th of 2000 higher than 1,768 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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