Subcellular Technology Lab., N.N. Petrov National Medical Research Center of Oncology, 197758 St. Petersburg, Russia.
Department of Gynecological Oncology, N.N. Petrov National Medical Research Center of Oncology, 197758 St. Petersburg, Russia.
Int J Mol Sci. 2023 May 23;24(11):9114. doi: 10.3390/ijms24119114.
Cervical cancer is one of the most common gynecological malignancies and it is preventable through the yearly diagnosis and management of pre-cancerous cervical disease. The profile of miRNA expression in cervical epithelium cells is altered with cervical dysplasia development and further progression. The NOVAprep-miR-CERVIX is a new approach for the assessment of cervical dysplasia through the analysis of six marker miRNAs. This study aims to evaluate theperformance and diagnostic potency of the new method. Cytological smears from 226 women (NILM, n.114; HSIL, n.112) were included in the study. A VPH test was performed with RealBest DNAHPV HR screen Kit, six marker miRNAs (miR-21, -29b, -145, -451a, -1246, -1290) were assayed using NOVAprep-miR-CERVIX kit. Obtained data were analyzed using the Delta Ct method and random forest machine learning algorithm. The results of the quantitative analysis of six microRNAs were expressed as a miR-CERVIX parameter, which ranged from 0 to 1, where "0" corresponded to the healthy cervical epithelium, while "1" corresponded to high-grade squamous intraepithelial dysplasia. The average value of miR-CERVIX differed in groups of NILM and HSIL samples (0.34 vs. 0.72; < 0.000005). An estimation of miR-CERVIX allowed for the differentiation between healthy and pre-cancerous samples with sensitivity of 0.79 and specificity of 0.79, as well as to confirm HSIL with specificity of 0.98. Interestingly, the HSIL group included HPV(+) and HPV(-) samples, which were statistically significantly different in terms of miR-CERVIX value. Analysis of CC-associated miRNAs in material of cervical smear might serve as an additional method for the evaluation of cervical dysplasia severity.
宫颈癌是最常见的妇科恶性肿瘤之一，可以通过每年对癌前宫颈疾病的诊断和管理来预防。宫颈上皮细胞中 miRNA 表达谱随着宫颈发育不良的发展和进一步进展而改变。NOVAprep-miR-CERVIX 是一种通过分析六种标记 miRNA 评估宫颈发育不良的新方法。本研究旨在评估新方法的性能和诊断效力。将 226 名女性的细胞学涂片（NILM，n.114；HSIL，n.112）纳入研究。使用 RealBest DNAHPV HR 屏幕试剂盒进行 HPV 检测，使用 NOVAprep-miR-CERVIX 试剂盒检测六种标记 miRNA（miR-21、-29b、-145、-451a、-1246、-1290）。使用 Delta Ct 方法和随机森林机器学习算法分析获得的数据。六种 microRNA 的定量分析结果表示为 miR-CERVIX 参数，范围从 0 到 1，其中“0”对应于健康的宫颈上皮，而“1”对应于高级别鳞状上皮内瘤变。NILM 和 HSIL 样本组的 miR-CERVIX 平均值不同（0.34 对 0.72；<0.000005）。miR-CERVIX 的估计值可区分健康和癌前样本，灵敏度为 0.79，特异性为 0.79，还可特异性确认 HSIL 为 0.98。有趣的是，HSIL 组包括 HPV(+) 和 HPV(-) 样本，它们在 miR-CERVIX 值方面存在统计学显著差异。分析宫颈涂片材料中的 CC 相关 miRNA 可能作为评估宫颈发育不良严重程度的附加方法。
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