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Abstract：
BACKGROUND: To date, carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) have been widely used for the screening, diagnosis and prediction of biliary tract cancer (BTC) patients. However, few studies with large sample sizes of carbohydrate antigen 50 (CA50) were reported in BTC patients.
METHODS: A total of 1121 patients from the Liver Cancer Clin-Bio Databank of Anhui Hepatobiliary Surgery Union between January 2017 and December 2022 were included in this study (673 in the training cohort and 448 in the validation cohort): among them, 458 with BTC, 178 with hepatocellular carcinoma (HCC), 23 with combined hepatocellular-cholangiocarcinoma, and 462 with nontumor patients. Receiver operating characteristic (ROC) curves and decision curve analysis (DCA) were used to evaluate the diagnostic efficacy and clinical usefulness.
RESULTS: ROC curves obtained by combining CA50, CA19-9, and AFP showed that the AUC value of the diagnostic MODEL 1 was 0.885 (95% CI 0.856-0.885, specificity 70.3%, and sensitivity 84.0%) in the training cohort and 0.879 (0.841-0.917, 76.7%, and 84.3%) in the validation cohort. In addition, comparing iCCA and HCC (235 in the training cohort, 157 in the validation cohort), the AUC values of the diagnostic MODEL 2 were 0.893 (95% CI 0.853-0.933, specificity 96%, and sensitivity 68.6%) in the training cohort and 0.872 (95% CI 0.818-0.927, 94.2%, and 64.6%) in the validation cohort.
CONCLUSIONS: The model combining CA50, CA19-9, and AFP not only has good diagnostic value for BTC but also has good diagnostic value for distinguishing iCCA and HCC.
METHODS: A total of 1121 patients from the Liver Cancer Clin-Bio Databank of Anhui Hepatobiliary Surgery Union between January 2017 and December 2022 were included in this study (673 in the training cohort and 448 in the validation cohort): among them, 458 with BTC, 178 with hepatocellular carcinoma (HCC), 23 with combined hepatocellular-cholangiocarcinoma, and 462 with nontumor patients. Receiver operating characteristic (ROC) curves and decision curve analysis (DCA) were used to evaluate the diagnostic efficacy and clinical usefulness.
RESULTS: ROC curves obtained by combining CA50, CA19-9, and AFP showed that the AUC value of the diagnostic MODEL 1 was 0.885 (95% CI 0.856-0.885, specificity 70.3%, and sensitivity 84.0%) in the training cohort and 0.879 (0.841-0.917, 76.7%, and 84.3%) in the validation cohort. In addition, comparing iCCA and HCC (235 in the training cohort, 157 in the validation cohort), the AUC values of the diagnostic MODEL 2 were 0.893 (95% CI 0.853-0.933, specificity 96%, and sensitivity 68.6%) in the training cohort and 0.872 (95% CI 0.818-0.927, 94.2%, and 64.6%) in the validation cohort.
CONCLUSIONS: The model combining CA50, CA19-9, and AFP not only has good diagnostic value for BTC but also has good diagnostic value for distinguishing iCCA and HCC.
摘要：
背景：迄今为止，糖类抗原19-9(CA19-9)和癌胚抗原(CEA)已被广泛用于筛查,胆道癌（BTC）患者的诊断和预测。然而,在BTC患者中报道了大量碳水化合物抗原50(CA50)的研究。
方法：本研究纳入2017年1月至2022年12月安徽省肝胆外科联盟肝癌Clin-Bio数据库的1121例患者（训练队列673例，验证队列448例）：458与BTC，178例肝细胞癌（HCC），23合并肝细胞-胆管癌，462例非肿瘤患者。应用接收人工作特点(ROC)曲线和判定曲线剖析(DCA)评价诊断效能和临床有用性。
结果：结合CA50，CA19-9和AFP获得的ROC曲线显示诊断模型1的AUC值为0.885（95％CI0.856-0.885，特异性70.3％，和敏感性84.0%）在训练队列中和0.879（0.841-0.917，76.7%，和84.3%)在验证队列中。此外,比较iCCA和HCC(训练队列中的235，157在验证队列中)，诊断模型2的AUC值为0.893（95%CI0.853-0.933，特异性96%，和敏感性68.6%)在训练队列中和0.872(95%CI0.818-0.927，94.2%，和64.6%)在验证队列中。
结论：结合CA50、CA19-9和AFP的模型不仅对BTC具有良好的诊断价值，而且对区分iCCA和HCC也具有良好的诊断价值。
方法：本研究纳入2017年1月至2022年12月安徽省肝胆外科联盟肝癌Clin-Bio数据库的1121例患者（训练队列673例，验证队列448例）：458与BTC，178例肝细胞癌（HCC），23合并肝细胞-胆管癌，462例非肿瘤患者。应用接收人工作特点(ROC)曲线和判定曲线剖析(DCA)评价诊断效能和临床有用性。
结果：结合CA50，CA19-9和AFP获得的ROC曲线显示诊断模型1的AUC值为0.885（95％CI0.856-0.885，特异性70.3％，和敏感性84.0%）在训练队列中和0.879（0.841-0.917，76.7%，和84.3%)在验证队列中。此外,比较iCCA和HCC(训练队列中的235，157在验证队列中)，诊断模型2的AUC值为0.893（95%CI0.853-0.933，特异性96%，和敏感性68.6%)在训练队列中和0.872(95%CI0.818-0.927，94.2%，和64.6%)在验证队列中。
结论：结合CA50、CA19-9和AFP的模型不仅对BTC具有良好的诊断价值，而且对区分iCCA和HCC也具有良好的诊断价值。
