Evidence map›Paper›PMID 39495136›Full record

ArticleHepatology communications2024

National Liver Cancer Screening Trial (TRACER) study protocol.

Amit G Singal, Neehar D Parikh, Fasiha Kanwal, Jorge A Marrero, Sneha Deodhar, Stephanie Page-Lester, Camden Lopez, Ziding Feng, Nabihah Tayob

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Hepatology communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06084234 (National Liver Cancer Screening Trial), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06084234 phase4recruitingnot on this map

National Liver Cancer Screening Trial

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2023 to 2034Enrolled5,500ConditionsCarcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis BArmsGALAD, Liver Ultrasound with or without AFP
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Practice changing RCT design and rationale: Abbreviated MRI plus AFPJHEP reports : innovation in hepatology · 2026
    Review
  10. Article
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Amit G SingalDepartment of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas, USA.
Neehar D ParikhDepartment of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Fasiha KanwalDepartment of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Jorge A MarreroDepartment of Internal Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Sneha DeodharDepartment of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas, USA.
Stephanie Page-LesterBiostatistics Program, Public Health Science Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Camden LopezBiostatistics Program, Public Health Science Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Ziding FengBiostatistics Program, Public Health Science Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Nabihah TayobDepartment of Data Science, Dana Farber Cancer Institute, Boston, Massachusetts, USA.

Funding

The Early Detection Research Network: Data Management and Coordinating CenterU24CA086368 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI RUTH D ETZIONI, Ziding Feng · 2010 to 2026
$75.7M
Clinical Validation Center for Hepatocellular CarcinomaU01CA271887 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI FASIHA KANWAL, JORGE A MARRERO · 2022 to 2026
$4.7M
NCI NIH HHS U01 CA271887NCI NIH HHS U24 CA086368
6 · The paper itself

Abstract

backgroundProfessional guidelines recommend HCC screening in at-risk patients using semi-annual ultrasound with or without alpha-fetoprotein (AFP); however, this strategy has limited effectiveness due to low adherence and sensitivity. Increasing data support the potential role of blood-based biomarker panels, which could improve both aspects. The biomarker panel GALAD, comprised of sex, age, and 3 blood biomarkers (AFP, AFP-L3, and des-carboxy prothrombin des-carboxy prothrombin), has shown high sensitivity and specificity in biomarker phase II (case-control) and phase III (retrospective cohort) validation studies. However, prospective validation in a large phase IV biomarker clinical utility trial is necessary before its adoption in practice.

methodsThe National Liver Cancer Screening Trial is an adaptive pragmatic randomized phase IV trial, which began enrollment in January 2024, comparing ultrasound-based versus biomarker-based screening in 5500 patients with chronic hepatitis B infection or cirrhosis from any etiology. Eligible patients are randomly assigned in a 1:1 ratio to semi-annual screening with ultrasound ± alpha-fetoprotein (arm A) or semi-annual screening with GALAD (arm B). Randomization is stratified by enrollment site, liver disease severity (per Child-Pugh class), liver disease etiology (viral, nonviral, and noncirrhotic HBV), and sex. Patients are being recruited from 15 sites (a mix of tertiary care academic referral centers, safety-net health systems, and large community health systems) over a 3-year period, and the primary endpoint, reduction in late-stage HCC, will be assessed at the end of year 5.5. DISCUSSION: The results of this trial will inform the best strategy for HCC screening and early-stage detection in patients with chronic liver diseases. If GALAD shows superiority, HCC screening would primarily shift from an ultrasound-based strategy to the adoption of the biomarker panel.

trial registrationNCT06084234. TRIAL STATUS: The TRACER Study is actively enrolling.

Indexed as

Early Detection of CancerLiver NeoplasmsAdultAgedalpha-FetoproteinsBiomarkersBiomarkers, TumorCarcinoma, HepatocellularClinical Trials, Phase IV as TopicFemaleHepatitis B, ChronicHumansLiver CirrhosisMaleMiddle AgedPragmatic Clinical Trials as TopicacarboxyprothrombinAFP protein, humanalpha-FetoproteinsBiomarkersBiomarkers, TumorProtein PrecursorsProthrombin

Identifiers

PMID39495136
PMCPMC11537583

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.