Kirk Gregory D, Nsibirwa Sara, Aizire Jim K, Assefa Redeat L, Bandala-Jacques Antonio, Orem Jackson, Maponga Tongai, Seydi Moussa, Wandeler Gilles, Mohareb Amir, Thomas David L, Okuku Fred, Ochola Emmanuelle, Ocama Ponsiano
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Department of Medicine, Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, MD.
JCO Glob Oncol. 2025 Jun;11:e2400592. doi: 10.1200/GO-24-00592. Epub 2025 Jun 11.
Hepatocellular carcinoma (HCC) is common and deadly in sub-Saharan Africa, where advanced imaging techniques, such as computerized tomography and magnetic resonance imaging, are scarce. The purpose of this study was to develop a pragmatic HCC diagnostic strategy for such settings.
We evaluated standardized protocol-collected data on clinical, ultrasonographic, biochemical, and pathological criteria in a multisite study of 649 suspected HCC cases in Uganda. Participants underwent standardized interviews, clinical assessments, and ultrasound examinations by trained staff with alpha-fetoprotein (AFP) testing at a central laboratory, and pathology was obtained for selected participants. Concordance analysis and percentage-confirmed yield using different HCC case definitions were performed, with survival follow-up as a validation measure.
The median age was 45 years, 68% were male, and 45% had chronic hepatitis B infection. Ultrasonographic, biochemical (AFP), and pathological definitions confirmed 91%, 57%, and 17% of clinically defined HCC cases, respectively. The median survival after diagnosis was 46 days. An integrated HCC case definition that combined clinical criteria with one confirmatory test increased the percentage-confirmed yield by 3.7% (ultrasonographic), 37.7% (biochemical), and 77.7% (pathologic) over the clinical definition alone. Yield from AFP or pathology beyond ultrasound was minimal. Survival did not differ appreciably by HCC case definition. This integrated HCC case definition maintained diagnostic rigor while maximizing yield.
We propose an integrated HCC case definition as a pragmatic, resource-adaptable approach for clinical diagnosis and research in sub-Saharan Africa. This definition can be readily implemented and can support regional collaborative efforts to develop novel diagnostics and improved treatments to ameliorate the heavy HCC burden.
肝细胞癌（HCC）在撒哈拉以南非洲地区常见且致命，而该地区缺乏计算机断层扫描和磁共振成像等先进成像技术。本研究的目的是为这类地区制定一种实用的HCC诊断策略。
我们在乌干达对649例疑似HCC病例进行了多中心研究，评估了根据标准化方案收集的临床、超声、生化和病理标准数据。参与者接受了标准化访谈、临床评估，并由经过培训的工作人员进行超声检查，同时在中央实验室进行甲胎蛋白（AFP）检测，并为部分参与者获取病理结果。使用不同的HCC病例定义进行一致性分析和确诊率分析，并将生存随访作为验证指标。
中位年龄为45岁，68%为男性，45%有慢性乙型肝炎感染。超声、生化（AFP）和病理定义分别确诊了临床定义的HCC病例的91%、57%和17%。诊断后的中位生存期为46天。将临床标准与一项确诊检查相结合的综合HCC病例定义，相较于仅依据临床定义，确诊率提高了3.7%（超声）、37.7%（生化）和77.7%（病理）。超声检查之外，AFP或病理检查的确诊率增幅极小。不同HCC病例定义的生存期无明显差异。这种综合HCC病例定义在保证诊断严谨性的同时实现了确诊率最大化。
我们提出一种综合HCC病例定义，作为撒哈拉以南非洲地区临床诊断和研究的实用、资源适配型方法。该定义易于实施，可支持区域合作努力，以开发新型诊断方法和改进治疗手段，减轻沉重的HCC负担。
