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Combination of ultrasonography with alpha-fetoprotein, lecithin-bound alpha-fetoprotein, and des-gamma-carboxy prothrombin for hepatocellular carcinoma surveillance in Thailand; A multi-centered randomized controlled trial

Combination of ultrasonography with alpha-fetoprotein, lecithin-bound alpha-fetoprotein, and des-gamma-carboxy prothrombin for hepatocellular carcinoma surveillance in Thailand; A multi-centered randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251127008
Enrollment
3124
Registered
2025-11-27
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persons who have high risk of developing HCC Early HCC detection, AFP, PIVKAII, AFP-L3, GALAD score,

Interventions

Addition of AFP, PIVKA-II and AFP-L3 to standard of care which is Ultrasound ,Addition of HCC biomarkers to routing ultrasound for routine HCC screening in high-risk group
GALAD,Only Ultrasound

Sponsors

Ministry of Economy, Trade and Industry (METI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients must be 18 years or older and be at high risk for HCC, defined as meeting at least one of the following criteria: 1. Cirrhosis from any cause. 2. Non-cirrhotic HBV, untreated, with a REACH-B score >8. 3. Non-cirrhotic HBV, on treatment, with a Modified PAGE-B score 9. 4. History of HCC in a first-degree relative.

Exclusion criteria

Exclusion criteria: 1.Previous diagnosis of HCC , diagnosis of any other malignancy (excluding basal cell carcinoma) 2. Current use of anticoagulant medication 3. Comorbidities associated with an expected survival of less than 1 year.

Design outcomes

Primary

MeasureTime frame
Rate of hepatocellular carcinoma detection within 1 year of the study New hepatocellular carcinoma detected by imaging

Secondary

MeasureTime frame
Early case of HCC 6, 12 month Radiology (CT or MRI)

Countries

Thailand

Contacts

Public ContactNaraporn Prayoonwiwat

Siriraj Hospital/Mahidol University

siriraj_IRB@mahidol.ac.th024192667

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026