By InvitationNot Applicable

STOP HCC-GAAD-APAC-Thailand

Thailand2,100 participantsStarted 2025-02-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Diagnosis of any active malignancy other than non-melanoma skin cancer * History of previously diagnosed malignancy, including prior hepatocellular carcinoma * Life expectancy of less than 2 years * Use of vitamin K antagonists within 1 week prior to enrollment * Pregnant or breastfeeding women * Estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m² * Significant hepatic decompensation or Child-Pugh class C liver disease * 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

What they're measuring

True Positive Rate (Sensitivity) of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities

Timeframe: Over 24 months of patient follow-up

False Positive Rate of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities

Timeframe: Over 24 months of patient follow-up

True Positive Rate (Sensitivity) of Combined Ultrasound + GAAD Score for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

False Positive Rate of Combined Ultrasound + GAAD Score for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

True Positive Rate (Sensitivity) of Combined Ultrasound + AFP for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

False Positive Rate of Combined Ultrasound + AFP for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

Trial details

NCT IDNCT07319299

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Hepatecellular Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

True Positive Rate (Sensitivity) of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities

Timeframe: Over 24 months of patient follow-up

False Positive Rate of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities

Timeframe: Over 24 months of patient follow-up

True Positive Rate (Sensitivity) of Combined Ultrasound + GAAD Score for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

False Positive Rate of Combined Ultrasound + GAAD Score for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

True Positive Rate (Sensitivity) of Combined Ultrasound + AFP for HCC Surveillance

Timeframe: Over 24 months of patient follow-up

False Positive Rate of Combined Ultrasound + AFP for HCC Surveillance

Timeframe: Over 24 months of patient follow-up