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

Enrolling by invitation · Not applicable

Conditions studied: Liver Cirrhosis, Hepatitis B, Chronic, Hepatitis C, Chronic, Carcinoma, Hepatocellular

In brief

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.

Key facts

Study ID

NCT07298577

Run by

Siriraj Hospital

People needed

2100

Starts

2026-02-02

Expected to finish

2030-07-31

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Faculty of Medicine Siriraj Hospital — Bangkok Noi, Bangkok, Thailand

Full record on ClinicalTrials.gov

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