NCT07319299Enrolling by invitation
STOP HCC-GAAD-APAC-Thailand
A Prospective, Interventional, Longitudinal APAC Study Evaluating Clinical Utility of GAAD Score for Detection of Hepatocellular Carcinoma in a High-risk APAC Patient Population
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 2100 (estimated)
- First submitted
- 15 Nov 2025
- Start date
- 2 Feb 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Mahidol University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07319299
What you commit to
- Study type: Interventional
- Planned participants: 2100
- From 2 Feb 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previously diagnosed malignancy, including prior hepatocellular carcinoma
- Use of vitamin K antagonists within 1 week prior to enrollment
Other illness
- Diagnosis of any active malignancy other than non-melanoma skin cancer
- Significant hepatic decompensation or Child-Pugh class C liver disease
Lab values
- Estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m²
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital Coordinator of this site? Confirm its status | Bangkoknoi | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.