需要对肝细胞癌 (HCC) 进行更好的监测测试。 GALAD 评分（性别、年龄、甲胎蛋白 [AFP] L3、AFP 和去羧基凝血酶原）已在 2 期研究中显示出对 HCC 具有出色的敏感性和特异性。我们进行了一项 3 期生物标志物验证研究，以比较 GALAD 与 AFP 在检测 HCC 方面的情况。这是一项针对 7 个中心招募的肝硬化患者的前瞻性研究。每个地点每 6 个月进行一次 HCC 监测，并根据美国肝病研究协会指南确认 HCC 诊断。每次随访时都会采集用于生物标志物研究的血液并储存在生物样本库中。 AFP、AFP-L3 和 des-γ 羧基凝血酶原的测量由不了解临床数据的工作人员在 FujiFilm 实验室进行。在临床诊断前12个月内回顾性评估GALAD检测HCC的性能。所有分析均由 EDRN 数据管理和协调中心的非盲统计学家进行。共有 1,558 名肝硬化患者入组，并进行中位随访 2.2 年。共有 109 名患者发展为 HCC（76 名极早期或早期患者），年发病率为 2.4%。 HCC 前 12 个月内 AFP 和 GALAD 的曲线下面积分别为 0.66 和 0.78 (P < .001)。使用 GALAD 的截止值 -1.36，特异性为 82%，HCC 诊断前 12 个月的敏感性为 62%。作为比较，AFP 的特异性为 82%，在 HCC 诊断前 12 个月显示出 41% 的敏感性 (P = .001)。与 AFP 相比，GALAD 评分提高了实际诊断前 12 个月内 HCC 的检出率。版权所有 © 2024 AGA 研究所。版权所有。

Better surveillance tests for hepatocellular carcinoma (HCC) are needed. The GALAD score (gender, age, α-fetoprotein [AFP] L3, AFP, and des 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.This 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 EDRN data management and coordinating center.A 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).GALAD score, compared to AFP, improves the detection of HCC within 12 months before the actual diagnosis.Copyright © 2024 AGA Institute. All rights reserved.