Attallah Kareem A, Albannan Mohamed S, Farid Khaled, Rizk Sherine M, Fathy Nevine
Research and Development Department, Biotechnology Research Center, New Damietta, Egypt.
Clinical Research Department, Damietta Directorate for Health Affairs, Egyptian Ministry of Health and Population, Damietta, Egypt.
Technol Cancer Res Treat. 2024 Jan-Dec;23:15330338241234790. doi: 10.1177/15330338241234790.
Hepatocellular carcinoma is frequently diagnosed in advanced stages, leading to a poorer prognosis. Therefore, early diagnosis and identification of biomarkers may significantly improve outcomes. This cross-sectional study enrolled 486 participants distributed among 3 groups: F1 to F3 = 184, F4 = 183, and hepatocellular carcinoma = 119. Liver fibrosis staging was performed using FibroScan, while imaging features were used for hepatocellular carcinoma detection. Epithelial membrane antigen and cytokeratin-1 levels in serum were quantified through Western blot and ELISA, respectively. Patients diagnosed with hepatocellular carcinoma exhibited significantly elevated levels of epithelial membrane antigen and cytokeratin-1 compared to non-hepatocellular carcinoma patients, with a highly significant statistical difference (< .0001). Epithelial membrane antigen demonstrated diagnostic performance with an area under the curve of 0.75, a sensitivity of 69.0%, and a specificity of 68.5%. Cytokeratin-1 for the identification of hepatocellular carcinoma showed a sensitivity of 79.0% and a specificity of 81.4%, resulting in an area under the curve of 0.87. The developed HCC-Check, which incorporates epithelial membrane antigen, cytokeratin-1, albumin, and alpha-fetoprotein, displayed a higher area under the curve of 0.95 to identify hepatocellular carcinoma, with a sensitivity of 89.8% and a specificity of 83.9%. Notably, HCC-Check values exceeding 2.57 substantially increased the likelihood of hepatocellular carcinoma, with an estimated odds ratio of 50.65, indicating a higher susceptibility to hepatocellular carcinoma development than those with lower values. The HCC-Check diagnostic test exhibited high precision in identifying patients with hepatocellular carcinoma, particularly those with small tumor sizes (<5 cm) and a single nodule, as reflected in area under the curve values of 0.92 and 0.85, respectively. HCC-Check was then applied to the validation study to test its accuracy and reproducibility, showing superior area under the curves for identifying different stages of hepatocellular carcinoma. These outcomes underscore the effectiveness of the test in the early detection of hepatocellular carcinoma. The HCC-Check test presents a highly accurate diagnostic method for detecting hepatocellular carcinoma in its early stages.
肝细胞癌常被诊断为晚期，导致预后较差。因此，早期诊断和生物标志物的识别可能会显著改善治疗结果。这项横断面研究招募了486名参与者，分为3组：F1至F3组 = 184人，F4组 = 183人，肝细胞癌组 = 119人。使用FibroScan进行肝纤维化分期，同时利用影像学特征检测肝细胞癌。分别通过蛋白质印迹法和酶联免疫吸附测定法定量血清中的上皮膜抗原和细胞角蛋白-1水平。与非肝细胞癌患者相比，被诊断为肝细胞癌的患者上皮膜抗原和细胞角蛋白-1水平显著升高，具有高度显著的统计学差异（<0.0001）。上皮膜抗原的诊断性能曲线下面积为0.75，灵敏度为69.0%，特异性为68.5%。用于识别肝细胞癌的细胞角蛋白-1灵敏度为79.0%，特异性为81.4%，曲线下面积为0.87。开发的HCC-Check结合了上皮膜抗原、细胞角蛋白-1、白蛋白和甲胎蛋白，用于识别肝细胞癌的曲线下面积更高，为0.95，灵敏度为89.8%，特异性为83.9%。值得注意的是，HCC-Check值超过2.57会大幅增加患肝细胞癌的可能性，估计比值比为50.65，表明比低值者患肝细胞癌的易感性更高。HCC-Check诊断测试在识别肝细胞癌患者方面表现出高精度，尤其是肿瘤较小（<5 cm）且为单个结节的患者，曲线下面积值分别为0.92和0.85。然后将HCC-Check应用于验证研究以测试其准确性和可重复性，结果显示在识别肝细胞癌不同阶段方面曲线下面积更优。这些结果强调了该测试在肝细胞癌早期检测中的有效性。HCC-Check测试为早期检测肝细胞癌提供了一种高度准确的诊断方法。
