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Enrolling by invitationNo phase

STOP HCC-GAAD-APAC-Thailand

Key facts

Where
Bangkoknoi, ThailandSee the site

Where in Thailand

  • Faculty of Medicine Siriraj HospitalBangkoknoi, ThailandNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Mahidol University
Trial code
NCT07319299
Record updated
6 January 2026
Original description
Hepatocellular carcinoma (HCC) surveillance is frequently underutilized, and currently available biomarkers, such as alpha-fetoprotein (AFP), demonstrate suboptimal diagnostic performance. This prospective study aims to evaluate a simplified multivariate index, the GAAD score-comprising gender, age, alpha-fetoprotein (AFP), and protein induced by vitamin K absence or antagonist-II (PIVKA-II)-for its ability to improve the detection of hepatocellular carcinoma in patients with chronic liver disease.Read full original descriptionShow less

A Prospective, Interventional, Longitudinal APAC Study Evaluating Clinical Utility of GAAD Score for Detection of Hepatocellular Carcinoma in a High-risk APAC Patient Population

Hepatocellular carcinoma (HCC) surveillance is frequently underutilized, and currently available biomarkers, such as alpha-fetoprotein (AFP), demonstrate suboptimal diagnostic performance. This prospective study aims to evaluate a simplified multivariate index, the GAAD score-comprising gender, age, alpha-fetoprotein (AFP), and protein induced by vitamin K absence or antagonist-II (PIVKA-II)-for its ability to improve the detection of hepatocellular carcinoma in patients with chronic liver disease.

The study hypothesizes that incorporation of the GAAD score into standard HCC surveillance strategies will improve diagnostic performance compared with existing surveillance modalities alone and may provide evidence to support its inclusion in future clinical practice guidelines.

Inclusion: Adults with chronic liver disease who have an indication for hepatocellular carcinoma (HCC) surveillance, including one or more of the following:; Liver cirrhosis of any etiology (e.g., chronic hepatitis B virus [HBV], chronic hepatitis C virus [HCV], metabolic dysfunction-associated steatohepatitis [MASH], or alcohol-related liver disease [ALD]); Non-cirrhotic chronic liver disease (e.g., HCV, MASH, or ALD) with evidence of stage F3 fibrosis; Chronic HBV infection with a clinical diagnosis of non-cirrhotic liver disease.

Exclusion: History of previously diagnosed malignancy, including prior hepatocellular carcinoma; Use of vitamin K antagonists within 1 week prior to enrollment; Diagnosis of any active malignancy other than non-melanoma skin cancer; Significant hepatic decompensation or Child-Pugh class C liver disease; Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m²; Life expectancy of less than 2 years; Pregnant or breastfeeding women; Unwillingness or inability to undergo computed tomography (CT) or magnetic resonance imaging (MRI); Unwillingness or inability to provide informed consent or to participate in the study.

ClinicalTrials.gov NCT07319299