Trial reportGastroenterology2025
A Phase 3 Biomarker Validation of GALAD for the Detection of Hepatocellular Carcinoma in Cirrhosis.
Trial report in Gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
47 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Diagnostic accuracy of surveillance tests for hepatocellular carcinoma in cirrhosis: a systematic review and network meta-analysis.BMJ open gastroenterology · 2026Pooled it
- Development and validation of a digital PCR assay targeting plasmaEpigenetics · 2026Article
- Hepatocellular carcinoma surveillance in Europe: challenges and lessons from global practice.The Lancet regional health. Europe · 2026Review
- The Malaysian Society of Gastroenterology and Hepatology Consensus Statements on Prevention and Early Detection of Hepatocellular Carcinoma in Malaysia.Journal of gastroenterology and hepatology · 2026Review
- Optimizing hepatocellular carcinoma screening in the era of metabolic dysfunction-associated steatotic liver disease and alcohol-related liver disease: time to lower the alpha-fetoprotein threshold.Journal of gastrointestinal oncology · 2026Article
- Multi-Target HCC Blood Test Demonstrates Consistent Performance Across Subgroups of Patients with Chronic Liver Disease.Cancers · 2026Article
- Methylation plus alpha-fetoprotein blood test for early detection of HCC in at-risk populations.Hepatology communications · 2026Article
- Article
- Hepatocellular carcinoma surveillance-is it time to update clinical practice?Hepatobiliary surgery and nutrition · 2026Article
- IL4I1+ macrophages drive hepatocellular carcinoma progression by responding to biomechanical cues.JHEP reports : innovation in hepatology · 2026Article
- Whole-Genome Bisulfite Sequencing Identifies Blood-Based DNA Methylation Biomarker for Hepatocellular Carcinoma.Molecular carcinogenesis · 2026Article
- Developing blood extracellular vesicle protein biomarkers for hepatocellular carcinoma: mechanisms, methods, and translation.Journal of nanobiotechnology · 2026Review
- Clinical applications of immunogenomics in hepatocellular carcinoma.Clinical and molecular hepatology · 2026Review
- Management and Prognosis of HCC Patients With Elevated Tumor Markers but no Imaging Recurrence After Radiofrequency Ablation.Cancer medicine · 2026Article
- Global Advances in Hepatocellular Carcinoma Research and Therapy in 2025.Cancer innovation · 2026Review
- Circulating Interleukin-37 as a Biomarker Candidate for Hepatocellular Carcinoma in Decompensated Advanced Chronic Liver Disease.Life (Basel, Switzerland) · 2026Article
- Psychosocial impact of false-positive surveillance for hepatocellular carcinoma: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Refining surveillance of hepatocellular carcinoma in chronic hepatitis B through biomarker-based risk stratification.Hepatology communications · 2026Review
- HES V2.0 validation and performance compared to GALAD and ASAP in the HEDS cohort.Journal of hepatology · 2026Article
- Biomarkers for the Diagnosis of Cirrhosis and Cirrhosis-Related Complications.Gastroenterology clinics of North America · 2026Review
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
BACKGROUND &
aimsBetter surveillance tests for hepatocellular carcinoma (HCC) are needed. The GALAD score (gender, age, α-fetoprotein [AFP] L3, AFP, and des-γ carboxyprothrombin) has been shown to have excellent sensitivity and specificity for HCC in phase 2 studies. We performed a phase 3 biomarker validation study to compare GALAD with AFP in detecting HCC.
methodsThis is a prospective study of patients with cirrhosis enrolled at 7 centers. Surveillance for HCC was performed every 6 months at each site, and HCC diagnosis was confirmed per American Association for the Study of Liver Diseases guidelines. Blood for biomarker research was obtained at each follow-up visit and stored in a biorepository. Measurements of AFP, AFP-L3, and des-γ carboxyprothrombin) were performed in a FujiFilm laboratory by staff blinded to clinical data. The performance of GALAD in detecting HCC was retrospectively evaluated within 12 months before the clinical diagnosis. All analyses were conducted by an unblinded statistician in the Early Detection Research Network data management and coordinating center.
resultsA total of 1,558 patients with cirrhosis were enrolled and followed for a median of 2.2 years. A total of 109 patients developed HCC (76 very early or early stage), with an annual incident rate of 2.4%. The areas under the curve for AFP and GALAD within 12 months before HCC were 0.66 and 0.78 (P < .001), respectively. Using a cutoff for GALAD of -1.36, the specificity was 82%, and the sensitivity at 12 months before HCC diagnosis was 62%. For comparison, performance of AFP at 82% specificity showed 41% sensitivity at 12 months before HCC diagnosis (P = .001).
conclusionsGALAD score, compared to AFP, improves the detection of HCC within 12 months before the actual diagnosis.
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