Development and validation of GADA model for diagnosing hepatocellular carcinoma in Chinese hepatitis B patients
Year: 2026
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Chronic hepatitis B virus (HBV) infection accounts for more than 40% of hepatocellular carcinoma (HCC) cases worldwide. The GALAD (Gender, Age, alpha fetoprotein heterogeneity [AFP-L3], AFP, and des-gamma-carboxy prothrombin [PIVKA-II/DCP]) model has potential for enhancing HCC diagnosis. However, its diagnostic performance in HBV-associated chronic liver disease requires further optimization. This study aimed to establish a diagnostic model for HBV-associated HCC. METHODS: The data from 2190 patients with HBV-related liver diseases, including chronic hepatitis B (CHB), cirrhosis, and HCC were analysed. The GADA model was developed by omitting AFP-L3 for improved accessibility, and its performance was assessed via the area under the receiver operating characteristic curve (AUC). Validation was performed on 20,908 patients across ten hospitals. RESULTS: The simplified GADA model demonstrated exceptional diagnostic performance in identifying HBV-related HCC in the modeling group, achieving an AUC of 0.940 (95% CI, 0.927-0.952), with a sensitivity and specificity of 82.57% and 91.53%, respectively, surpassing the original GALAD model's AUC of 0.907 (95% CI, 0.891-0.921). In the internal validation cohort, the GADA model had an AUC of 0.935 (95% CI, 0.914-0.953), sensitivity of 82.04%, and specificity of 92.65%. For early-stage HCC detection, the AUC in the modeling group was 0.858 (95% CI, 0.837-0.877), and in the internal validation group was 0.868 (95% CI, 0.836-0.895), significantly better than the original GALAD model. External validation with 20,908 participants yielded an AUC of 0.919 (95% CI, 0.916-0.923), with sensitivity of 86.00% and specificity 81.88%. For early-stage HCC diagnosis, the AUC was 0.903 (95% CI: 0.898-0.907), with sensitivity of 88.16% and specificity 74.50%. CONCLUSIONS: The GADA model shows exceptional promise for diagnosing HBV-related HCC, enhancing early detection and reducing misdiagnosis rates. Its clinical utility is supported by robust validation, indicating significant implications for patient prognosis and treatment options.
Source: Chinese Medical Journal
Institutions: Peking University, Shihezi University, Qinghai Provincial Peoples Hospital, Second Affiliated Hospital of Chongqing Medical University, Southern University of Science and Technology, Shenzhen Third People’s Hospital, Peking University Shenzhen Hospital, First Affiliated Hospital Zhejiang University, Zhejiang University, Wuhan University, Wuhan Union Hospital, Fujian Medical University, First Affiliated Hospital of Fujian Medical University, Peking University People's Hospital, Shanxi Medical University, Second Hospital of Shanxi Medical University, Mengchao Hepatobiliary Hospital
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,000
OpenAlex ID: W7203723976