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Hepatecellular CarcinomaNCT07319299

STOP HCC-GAAD-APAC-Thailand

A study testing GAAD score in people with Hepatecellular Carcinoma and Cirrhosis, run by Mahidol University at 1 site in Thailand.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Hepatocellular carcinoma (HCC) surveillance is frequently underutilized, and currently available biomarkers, such as alpha-fetoprotein (AFP), demonstrate suboptimal diagnostic performance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatecellular Carcinoma, Cirrhosis, HBV Infection
What is being tested?
GAAD score
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,100 participants
Where
1 siteThailand
Study dates
2 Feb 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thailand1 site

  • Faculty of Medicine Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

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

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.

Read the detailed description

Surveillance and early detection of hepatocellular carcinoma (HCC) increase the likelihood of potentially curative treatment. However, HCC surveillance remains substantially underutilized, even in countries with adequate healthcare resources. Early-stage HCC can be treated with curative intent using local ablation, surgical resection, or liver transplantation.

The role of serum alpha-fetoprotein (AFP) in HCC surveillance varies across international guidelines. AFP is recommended for surveillance by the Asian Pacific Association for the Study of the Liver (APASL), considered optional by the American Association for the Study of Liver Diseases (AASLD), and not recommended by the European Association for the Study of the Liver (EASL). Similar considerations have informed recommendations for combined use of AFP with ultrasound (US) in HCC surveillance by the World Health Organization (WHO) Guidelines for the Prevention, Care and Treatment of Viral Hepatitis (references 1-4).

AFP has demonstrated suboptimal performance as a serologic surveillance marker for HCC. Serum AFP levels may fluctuate in patients with cirrhosis due to hepatitis B virus (HBV) or hepatitis C virus (HCV) activity, exacerbations of underlying liver disease, or the development of HCC, thereby limiting its diagnostic accuracy.

Recently, the GALAD score-a multivariable model incorporating gender, age, AFP-L3, AFP, and protein induced by vitamin K absence or antagonist-II (PIVKA-II)-has been proposed as an alternative approach to improve HCC detection and has demonstrated strong diagnostic performance in patients with cirrhotic HCC. A simplified version of this model, the GAAD score (Roche Diagnostics International Ltd., Rotkreuz, Switzerland), which includes gender, age, AFP, and PIVKA-II, has been shown to achieve comparable diagnostic performance in preliminary analyses (Piratvisuth et al., 2023, submitted).

However, the existing evidence supporting the use of the GALAD and GAAD scores is primarily derived from retrospective and/or case-control studies. Prospective validation in real-world surveillance settings remains limited. This study is therefore designed to prospectively evaluate the diagnostic performance of the GAAD score, alone and in combination with standard surveillance modalities, in patients with chronic liver disease undergoing routine HCC surveillance.

Being tested
GAAD score
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAAD scoreDiagnostic test

    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 of ≥ 2.57 will trigger a recall procedure, defined as further diagnostic evaluation using multiphasic contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) of the liver. This recall procedure is performed 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).

Study groups in NCT07319299
Study groupRoleWhat they receive
GAAD ScoreOtherAll 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).
Receives: Diagnostic Test: GAAD score

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    To evaluate the true positive rate (sensitivity) of Ultrasound, serum alpha-fetoprotein (AFP), and the GAAD score when used individually for hepatocellular carcinoma (HCC) surveillance. Sensitivity will be calculated for each modality separately by comparing surveillance results with the reference standard diagnosis of HCC. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

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

    To evaluate the false positive rate of Ultrasound, serum AFP, and the GAAD score when used individually for HCC surveillance. The false positive rate will be calculated for each modality separately based on surveillance results compared with the reference standard diagnosis. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

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

    To evaluate the true positive rate (sensitivity) of the combined Ultrasound and GAAD score strategy for HCC surveillance. A positive surveillance result will be defined according to the prespecified combination criteria (e.g., either test positive or both tests positive, as defined in the protocol). Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

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

    To evaluate the false positive rate of the combined Ultrasound and GAAD score strategy for HCC surveillance, using the reference standard diagnosis of HCC. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

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

    To evaluate the true positive rate (sensitivity) of the combined Ultrasound and serum AFP strategy for HCC surveillance, based on predefined combination criteria. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

  6. False Positive Rate of Combined Ultrasound + AFP for HCC Surveillance

    To evaluate the false positive rate of the combined Ultrasound and serum AFP strategy for HCC surveillance, compared with the reference standard diagnosis of HCC. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

Secondary outcomes (12)

  1. Area Under the Receiver Operating Characteristic Curve (AUC) of GAAD Compared With Ultrasound, AFP, and PIVKA-II

    • compare the overall discriminative ability of the GAAD algorithm with Ultrasound, serum AFP, and serum PIVKA-II for the detection of hepatocellular carcinoma (HCC). Performance will be assessed using the area under the receiver operating characteristic curve (AUC), stratified by HCC stage and underlying liver disease etiology. Unit of Measure: AUC (unitless)

    Measured: Over 24 months of patient follow-up

  2. Sensitivity and Specificity of GAAD Compared With Ultrasound, AFP, and PIVKA-II

    To compare the sensitivity and specificity of the GAAD algorithm with Ultrasound, serum AFP, and serum PIVKA-II for HCC surveillance. Sensitivity and specificity will be calculated separately for each modality and stratified by HCC stage and etiology. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

  3. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of GAAD Compared With Ultrasound, AFP, and PIVKA-II

    To compare the positive predictive value (PPV) and negative predictive value (NPV) of the GAAD algorithm with Ultrasound, serum AFP, and serum PIVKA-II for HCC surveillance, stratified by HCC stage and etiology. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

  4. Area Under the Receiver Operating Characteristic Curve (AUC) of Combined Ultrasound + AFP

    To evaluate the discriminative performance of the combined Ultrasound and serum AFP strategy for HCC surveillance using the area under the receiver operating characteristic curve (AUC), stratified by HCC stage and etiology. Unit of Measure: AUC (unitless)

    Measured: Over 24 months of patient follow-up

  5. Sensitivity and Specificity of Combined Ultrasound + AFP

    To evaluate the sensitivity and specificity of the combined Ultrasound and serum AFP strategy for HCC surveillance, stratified by HCC stage and etiology. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

  6. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Combined Ultrasound + AFP

    To evaluate the positive predictive value (PPV) and negative predictive value (NPV) of the combined Ultrasound and serum AFP strategy for HCC surveillance, stratified by HCC stage and etiology. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

  7. Longitudinal Changes in AFP Levels Prior to HCC Diagnosis

    To assess longitudinal changes in serum Elecsys AFP concentrations preceding an HCC diagnosis among confirmed HCC cases. Unit of Measure: Nanograms per milliliter (ng/mL)

    Measured: Over 24 months of patient follow-up

  8. Longitudinal Changes in PIVKA-II Levels Prior to HCC Diagnosis

    To assess longitudinal changes in serum Elecsys PIVKA-II concentrations preceding an HCC diagnosis among confirmed HCC cases. Unit of Measure: milli-arbitrary units per milliliter (mAU/mL)

    Measured: Over 24 months of patient follow-up

  9. Longitudinal Changes in GAAD Score Prior to HCC Diagnosis

    To assess longitudinal changes in the GAAD score preceding an HCC diagnosis among confirmed HCC cases. Unit of Measure: Unitless score

    Measured: Over 24 months of patient follow-up

  10. Number of Additional Early-Stage HCCs Detected Using GAAD

    To quantify the number of additional early-stage hepatocellular carcinoma cases identified using the GAAD score compared with standard surveillance modalities. Unit of Measure: Number of participants

    Measured: Over 24 months of patient follow-up

  11. Number of Additional CT or MRI Imaging Procedures Triggered by Surveillance Tests

    To count the number of additional CT or MRI imaging procedures triggered by positive results from GAAD, AFP, or Ultrasound surveillance tests. Unit of Measure: Number of imaging procedures

    Measured: Over 24 months of patient follow-up

  12. Relative False Positive Rate of Additional CT or MRI Imaging Procedures

    To calculate the relative false positive rate of additional CT or MRI imaging procedures triggered by positive GAAD, AFP, or Ultrasound surveillance results. Unit of Measure: Proportion (percentage)

    Measured: Over 24 months of patient follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start2 Feb 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
GAAD score
Masking
None (open label)
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319299
Sponsor's protocol ID
Si 089/2024
Status last verified
Dec 2025
First submitted
15 Nov 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets generated and/or analysed during the current study are not publicly available due to the policy of the institutes.

Publications

  • Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.

    PubMed 29425931

  • Best J, Bechmann LP, Sowa JP, Sydor S, Dechene A, Pflanz K, Bedreli S, Schotten C, Geier A, Berg T, Fischer J, Vogel A, Bantel H, Weinmann A, Schattenberg JM, Huber Y, Wege H, von Felden J, Schulze K, Bettinger D, Thimme R, Sinner F, Schutte K, Weiss KH, Toyoda H, Yasuda S, Kumada T, Berhane S, Wichert M, Heider D, Gerken G, Johnson P, Canbay A. GALAD Score Detects Early Hepatocellular Carcinoma in an International Cohort of Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2020 Mar;18(3):728-735.e4. doi: 10.1016/j.cgh.2019.11.012. Epub 2019 Nov 8.

    PubMed 31712073

  • Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15.

    PubMed 28620797

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.

    PubMed 29628281

  • Singal AG, Llovet JM, Yarchoan M, Mehta N, Heimbach JK, Dawson LA, Jou JH, Kulik LM, Agopian VG, Marrero JA, Mendiratta-Lala M, Brown DB, Rilling WS, Goyal L, Wei AC, Taddei TH. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023 Dec 1;78(6):1922-1965. doi: 10.1097/HEP.0000000000000466. Epub 2023 May 22. No abstract available.

    PubMed 37199193

Questions about this trial

What is this clinical trial studying?

A study testing GAAD score in people with Hepatecellular Carcinoma and Cirrhosis, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

True Positive Rate (Sensitivity) of Ultrasound, AFP, and GAAD Score as Standalone Surveillance Modalities (time frame: Over 24 months of patient follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07319299, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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