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RECRUITING Phase 4

National Liver Cancer Screening Trial

NCT06084234 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 742 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06084234 reports 18 study locations spanning 12 distinct geographic areas — top geographies include California, Michigan, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06084234?

The interventions under investigation include: GALAD (DIAGNOSTIC_TEST), Liver Ultrasound with or without AFP (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06084234?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 742 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial