Evidence map›Paper›PMID 41056497›Full record

ArticleHepatology communications2025

Performance of the multi-target hepatocellular carcinoma blood test: Design and rationale of the ALTUS study.

Binu V John, Mark Camardo, Kyle Porter, Paul Z Elias, Elle Kielar-Grevstad, Seema P Rego, Neehar D Parikh, Lewis R Roberts, Alvin C Silva, Amit G Singal and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Hepatology communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Binu V JohnDivision of Hepatology, Miami VA Medical Center, Miami, Florida, USA.
Mark CamardoExact Sciences Corporation, Madison, Wisconsin, USA.
Kyle PorterExact Sciences Corporation, Madison, Wisconsin, USA.
Paul Z EliasExact Sciences Corporation, Madison, Wisconsin, USA.ORCID 0009-0009-6984-5443
Elle Kielar-GrevstadExact Sciences Corporation, Madison, Wisconsin, USA.
Seema P RegoExact Sciences Corporation, Madison, Wisconsin, USA.
Neehar D ParikhDivision of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Lewis R RobertsDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Alvin C SilvaDepartment of Radiology, Mayo Clinic, Scottsdale, Arizona, USA.
Amit G SingalDivision of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Ju Dong YangSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Paul J LimburgExact Sciences Corporation, Madison, Wisconsin, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatocellular carcinoma (HCC) is a leading cause of cancer-related death in the United States and worldwide. HCC screening among patients at elevated risk is associated with improved early detection and overall survival, but current ultrasound-based screening strategies are challenged by low adherence and suboptimal sensitivity. Blood-based screening tests have the potential to enhance adherence and improve early-stage HCC detection if they can demonstrate favorable performance compared with ultrasound-based screening. Here we present the design and rationale for ALTUS (Alternative to Ultrasound), a prospective, longitudinal, multicenter study in the United States to investigate the performance of the multi-target HCC blood test (mt-HBT) for the detection of HCC in a screening population.

methodsAdults with liver cirrhosis or chronic hepatitis B infection will be enrolled to undergo standard-of-care screening imaging and concurrent blood collection for the mt-HBT. All participants will undergo contrast-enhanced CT or MRI imaging with central radiology LI-RADS assessment as the reference method to determine HCC status. Participants without an identified malignancy will undergo a second screening visit and blood collection, and longitudinal clinical and imaging data will be collected up to 18 months from enrollment. The primary study objectives are to demonstrate that the mt-HBT is non-inferior to ultrasound for early-stage HCC sensitivity and to assess mt-HBT HCC specificity. The secondary objective is to assess mt-HBT overall sensitivity.

resultsALTUS is in progress with readout of the primary analysis expected in 2025.

conclusionsThis prospective head-to-head comparison of the mt-HBT versus ultrasound will provide novel data regarding the performance and utility of the mt-HBT for HCC screening.

Indexed as

Biomarkers, TumorCarcinoma, HepatocellularEarly Detection of CancerLiver NeoplasmsAdultFemaleHepatitis B, ChronicHumansLiver CirrhosisLongitudinal StudiesMagnetic Resonance ImagingMaleMiddle AgedMulticenter Studies as TopicProspective StudiesTomography, X-Ray ComputedBiomarkers, Tumoralpha-fetoproteinhepatocellular carcinoma blood testhepatocellular carcinoma screeninghepatocellular carcinoma surveillanceliver ultrasound

Identifiers

PMID41056497
PMCPMC12506982

What Socratic holds

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LicenceCC BY
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Registered trials

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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 Socratic graph.