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NCT06084234 · ClinicalTrials.gov registry record · Phase 4
National Liver Cancer Screening Trial
A Phase 4 study of Liver Cancer and Hepatitis B, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 5,500
- Enrollment target
- 18
- Study locations
NCT06084234 is a Phase 4 study of Liver Cancer and Hepatitis B that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 5,500 participants, above the 377-participant average among 78 other Liver Cancer trials with a reported enrollment target (1359% higher). The trial reports 18 study locations across 12 states.
The verdict
NCT06084234, a Phase 4 study of Liver Cancer and Hepatitis B, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 5,500 participants
- Enrollment target
- 18
- Study locations
Study Summary
The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST GALAD
- DIAGNOSTIC_TEST Liver Ultrasound with or without AFP
Study Locations (18)
California
- University of Southern California - Los Angeles
- Stanford University - Redwood City
- Kaiser Permanente - Roseville
- University of California, San Francisco - San Francisco
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
Minnesota
- Hennepin Healthcare - Minneapolis
- University of Minnesota - Minneapolis
Texas
- UT Southwestern Medical Center and Parkland Hospital - Dallas
- Baylor College of Medicine - Houston
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
New York
- The Feinstein Institutes, Northwell Health, Inc. - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,500 participants |
| Start Date | 2023-12-26 |
| Est. Completion | 2034-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06084234
The ClinicalTrials.gov registry entry for NCT06084234 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 5,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 377-participant average among 78 other Liver Cancer trials with a reported enrollment target (1359% higher). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Liver Cancer appearing as the primary indexed condition, and to 2 interventions - of which GALAD is the first listed.
NCT06084234 reports 18 study locations spanning 12 distinct geographic areas - top geographies include California, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06084234 about?
NCT06084234 is a clinical study titled "National Liver Cancer Screening Trial". The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Ar...
What is the current status of trial NCT06084234?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 5,500 participants. The study started on 2023-12-26. Estimated completion is 2034-12-31.
What conditions does trial NCT06084234 study?
This clinical trial studies the following conditions: Liver Cancer, Hepatitis B, Carcinoma, Hepatocellular, Liver Cirrhosis.
What interventions are being tested in trial NCT06084234?
The interventions under investigation include: GALAD (DIAGNOSTIC_TEST), Liver Ultrasound with or without AFP (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06084234?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06084234 being conducted?
This trial has 18 study locations across California, Illinois, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.