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
Key facts
- Where
- Bangkok Noi, ThailandSee the site
Where in Thailand
- Faculty of Medicine Siriraj HospitalBangkok Noi, ThailandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Siriraj Hospital
- Trial code
- NCT07298577
- Record updated
- 24 April 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Interventional, Longitudinal Asia Pacific Study Evaluating Clinical Utility of Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score Plus Ultrasound for Detection of Hepatocellular Carcinoma (HCC) in a High-risk Patient Population
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.
Inclusion: 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: Pre-existing diagnosed malignancies, including previous HCC; Use of Vitamin K antagonists within one week before enrolment; Diagnosis with any cancer other than non-melanoma skin cancer; Glomerular filtration rate (GFR) < 60 mL/min/1.73 m²; Life expectancy of less than 2 years; Women who are pregnant or lactating; 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.