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Testing the GAAD score to find liver cancer in people with chronic liver disease

Tests a blood-based score for spotting liver cancer in people with chronic liver disease.

Key facts

Who runs it
Mahidol University
Where
Bangkoknoi, ThailandSee the site
Trial code
Registry title
STOP HCC-GAAD-APAC-Thailand
Status
Enrolling by invitation
People taking part
2,100 people, planned
Started
2 Feb 2025
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • GAAD score
Record updated
6 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-term liver disease who need regular checks for liver cancer. It tests a blood score called GAAD to find liver cancer.

Age
18 years or older
Sex
All sexes can join
Disease stage
Liver cirrhosis of any cause; or long-term liver disease without cirrhosis but with stage F3 fibrosis; or chronic hepatitis B infection without cirrhosis.
Earlier treatment
Cannot have used vitamin K antagonists within 1 week before joining.

Main reasons for not taking part

  • Any active cancer other than non-melanoma skin cancer
  • Earlier cancer, including earlier liver cancer
  • Life expectancy of less than 2 years
  • Pregnant or breastfeeding women
  • Kidney function (GFR) below 60 mL/min/1.73 m², or severe liver failure (Child-Pugh class C)

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Thailand

  • Faculty of Medicine Siriraj HospitalBangkoknoi, ThailandNo longer taking part

About the trial

What the trial wants to find out

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

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.

The group in the trial

  • GAAD ScoreOther group

    All enrolled participants will undergo standard hepatocellular carcinoma (HCC) surveillance consisting of blood sampling and abdominal ultrasound performed every 6 months for a total follow-up period of 24 months. Blood samples will be analyzed for serum alpha-fetoprotein (AFP) and protein induced by vitamin K absence or antagonist-II (PIVKA-II) to calculate the GAAD score, a multivariable index incorporating gender, age, AFP, and PIVKA-II. A GAAD score ≥ 2.57 will trigger a recall procedure, defined as diagnostic evaluation with multiphasic contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) of the liver. This recall procedure is conducted in addition to standard surveillance recall criteria, which include detection of a suspicious hepatic lesion measuring ≥ 1 cm on ultrasound or elevated or rising serum AFP levels (≥ 20 ng/mL).

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, Interventional, Longitudinal APAC Study Evaluating Clinical Utility of GAAD Score for Detection of Hepatocellular Carcinoma in a High-risk APAC Patient Population
Plain-language title
Testing the GAAD score to find liver cancer in people with chronic liver diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 January 2026