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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
True Positive Rate (Sensitivity) of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities
Timeframe: Over 24 months of patient follow-up
2
False Positive Rate of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities
Timeframe: Over 24 months of patient follow-up
3
True Positive Rate (Sensitivity) of Combined Ultrasound + GAAD Score for HCC Surveillance
Timeframe: Over 24 months of patient follow-up
4
False Positive Rate of Combined Ultrasound + GAAD Score for HCC Surveillance
Timeframe: Over 24 months of patient follow-up
5
True Positive Rate (Sensitivity) of Combined Ultrasound + AFP for HCC Surveillance
Timeframe: Over 24 months of patient follow-up
6
False Positive Rate of Combined Ultrasound + AFP for HCC Surveillance