By InvitationNot Applicable

Use of Gender, Age, Alfa-fetoprotein (AFP), and Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score in Addition to Ultrasound for Surveillance of People At-risk for Developing Hepatocellular Carcinoma in Asia in Order to Detect Early Liver Cancer

Thailand2,100 participantsStarted 2026-02-02

Plain-language summary

HCC surveillance is currently limited by underutilization and the suboptimal performance of AFP. This prospective, single-arm study investigates whether the GAAD score (Gender, Age, AFP, and PIVKA-II) enhances HCC detection when added to standard-of-care surveillance. High-risk patients will undergo US plus GAAD score testing every six months for two years. The primary analysis compares the relative true positive rate (rTPR) and relative false positive rate (rFPR) of surveillance modalities (US, AFP, GAAD) against combined strategies (US+AFP; US+GAAD), utilizing a 2.57 GAAD cut-off. Secondary endpoints include longitudinal biomarker kinetics, early-stage HCC detection rates, and the impact on downstream imaging (CT/MRI) volume. Ultimately, this study seeks to define the role of GAAD as a surveillance adjunct and inform future clinical guidelines for biomarker-enhanced HCC screening.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Signed informed consent form (ICF). * Age above 18 years. * Patients with chronic liver disease who have an indication for HCC surveillance, including: * Liver cirrhosis of any etiology (e.g., chronic HBV, HCV, NASH, alcohol). * Non-cirrhotic chronic liver disease (HCV, MASH, ALD) with evidence of F3 stage fibrosis. * Chronic HBV infection with a clinical diagnosis of non-cirrhosis Exclusion Criteria: * Diagnosis with any cancer other than non-melanoma skin cancer. * Pre-existing diagnosed malignancies, including previous HCC. * Life expectancy of less than 2 years. * Use of Vitamin K antagonists within one week before enrolment. * Women who are pregnant or lactating. * Glomerular filtration rate (GFR) \< 60 mL/min/1.73 m². * Significant hepatic decompensation or a Child-Pugh score of C. * Unwillingness or inability to undergo CT and MRI imaging. * Unwillingness to participate in the study.

What they're measuring

Occurrence of hepatocellular carcinoma (HCC)

Timeframe: 24 months of follow up

Relative True Positive Rate of Surveillance Modalities

Timeframe: 24 months

Relative False Positive Rate of Surveillance Modalities

Timeframe: 24 months

Trial details

NCT IDNCT07298577

SponsorSiriraj Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-02