GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score

Background/Aim: The GALAD scoreis a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma ( HCC) in patients with chronic liver disease. We aimed to assess the performance of the GALAD scorein comparison to liver ultrasoundfor detection of HCC. Methods: A single centercohort of 111 HCCand 180 controls with cirrhosis or chronic hepatitis B and a multicenter cohort of 233 early HCCand 412 cirrhosis patients from the Early Detection Research Network (EDRN) Phase 2 HCCStudy were analyzed. Results: The area under the ROC curve (AUC) of the GALAD scorefor HCCdetection was 0.95 [95% confidence interval (CI): 0.93-97], which was higher than the AUC of ultrasound (0.82, P<0.01). At a cut offof -0.76, the GALAD scorehad a sensitivity of 91% and a specificity of 85% for HCCdetection. The AUC of the GALAD scorefor early stage HCCdetection remained high at 0.92 [95%CI: 0.88-0.96] ( cut off-1.18, sensitivity 92%, specificity 79%). The AUC of the GALAD scorefor HCCdetection was 0.88 (95% CI, 0.85-0.91) in the EDRN cohort. The combination of GALAD and ultrasound (GALADUS score) further improved the performance of the GALAD scorein the single centercohort, achieving an AUC of 0.98 [95%CI: 0.96-0.99] ( cut off-0.18, sensitivity 95%, specificity 91%). Conclusions: The performance of the GALAD scorewas superior to ultrasound for HCCdetection. The GALADUS scorefurther enhanced the performance of the GALAD score. Impact: The GALAD scorewas validated in the US.