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National Liver Cancer Screening Trial

Study acronym: TRACER
StatusRecruiting
PhasePhase 4
Started2023-12-26
View on ClinicalTrials.gov ↗

Amendment history

2026-08-10
Study Status, Sponsor/Collaborators, Contacts/Locations v15
Study sites18→19
Collaborators6 to 7 entries
The Cleveland Clinic
2025-11-25
Study Status, Contacts/Locations v14
Study sites17→18
2025-08-07
Study Status, Oversight v13
Re-verified, no change to tracked fields
2025-07-22
Study Status, Contacts/Locations v12
Study sites14→17
2025-04-03
Study Status, Contacts/Locations v11
Study sites13→14
Show 10 earlier versions
2025-03-25
Study Status, Contacts/Locations v10
Study sites12→13
2025-03-02
Study Status, Contacts/Locations v9
Study sites10→12
2024-07-23
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 10 sites
2024-03-27
Study Status, Contacts/Locations v7
Study sitesdetails revised at 4 of 10 sites
2024-02-27
Study Status, Contacts/Locations v6
Study sitesdetails revised at 3 of 10 sites
2024-02-15
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 10 sites
2024-01-30
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 10 sites
2024-01-18
Study Status v3
Re-verified, no change to tracked fields
2024-01-16
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-01→confirmed 2023-12-26
Study sitesdetails revised at 10 of 10 sites
Study title-10 characters
National Liver Cancer Biomarker Screening Trial
2023-10-18
Study Status, Oversight, Study Description, Outcome Measures, Contacts/Locations v1
Secondary endpoints7 entries, revised
NumberProportion of participantsHCC incases receiptthat ofreceive Curative therapy
Study sitescontacts updated at 5 of 10 sites
2023-10-10
Original filing
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.
Trial Details
NCT Number NCT06084234
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: National Cancer Institute (NCI), University of Pennsylvania, University of Michigan, Dana-Farber Cancer Institute, Baylor College of Medicine, Fred Hutchinson Cancer Center, The Cleveland Clinic
Conditions Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B
Enrollment 5,500 participants
Start Date 2023-12-26
Primary Completion 2029-12-31 (estimated)
Study Completion 2034-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-25