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NCT07298577: STOPHCC-GAAD
Use of Gender, Age, Alfa-fetoprotein (AFP), and Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score in Addition to Ultrasound for Surveillance of People At-risk for Developing Hepatocellular Carcinoma in Asia in Order to Detect Early Liver Cancer
NA trial testing PIVKA-II and GAAD score calculation in Liver Cirrhosis in 2,100 participants. Not yet recruiting.
31 December 2029
Quick facts
| Lead sponsor | Siriraj Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 2,100 |
| Start date | 2 January 2026 |
| Primary completion | 31 December 2029 |
| Estimated completion | 30 June 2030 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- PIVKA-II and GAAD score calculation
Conditions studied
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
- Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →
- Hepatitis C, Chronic — all drugs for Hepatitis C, Chronic →
- Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
Sponsor
Siriraj Hospital
Who can join
18 and older, any sex, with Liver Cirrhosis or Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
HCC surveillance is currently limited by underutilization and the suboptimal performance of AFP. This prospective, single-arm study investigates whether the GAAD score (Gender, Age, AFP, and PIVKA-II) enhances HCC detection when added to standard-of-care surveillance. High-risk patients will undergo US plus GAAD score testing every six months for two years. The primary analysis compares the relative true positive rate (rTPR) and relative false positive rate (rFPR) of surveillance modalities (US, AFP, GAAD) against combined strategies (US+AFP; US+GAAD), utilizing a 2.57 GAAD cut-off. Secondary endpoints include longitudinal biomarker kinetics, early-stage HCC detection rates, and the impact on downstream imaging (CT/MRI) volume. Ultimately, this study seeks to define the role of GAAD as a surveillance adjunct and inform future clinical guidelines for biomarker-enhanced HCC screening.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07298577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07298577 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Siriraj Hospital
- Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07298577.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing