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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: Recruiting Phase 4 study of Liver Cancer and Hepatitis B, sponsored by University of Texas Southwestern Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Proportion of HCC detected at a late stage, defined as HCC beyond Milan Criteria (one tumor less than or equal to 5 cm or 2-3 tumors each less than or equal to 3 cm, in the absence of vascular invasion or extra-hepatic metastases)

Conditions Studied

Liver Cancer Hepatitis B Carcinoma, Hepatocellular Liver Cirrhosis

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

FieldValue
Enrollment Target 5,500 participants
Start Date 2023-12-26
Est. Completion 2034-12-31
Phase Phase 4
University of Texas Southwestern Medical Center

837 total trials

What NCT06084234 shows while recruiting

NCT06084234 is an interventional study that assigns participants to a tested intervention. Its 5,500 participants enrollment target places it among the larger protocols in the corpus, above the 377-participant average among 78 other Liver Cancer trials with a reported enrollment target (1359% higher).

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 lists 18 locations in 12 states (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.

Learn More About Clinical Trials

Similar trials for Liver Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06084234's enrollment target sits among peer trials

5,500 3rd of 78 higher than 76 of 78 other Liver Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Liver Cancer 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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More recruiting context for NCT06084234

Source: ClinicalTrials.gov NCT06084234, the US trial registry maintained by the National Library of Medicine. NCT06084234 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.