Unit of Urology, A.Gemelli Hospital - IRCCS, Catholic University of the Sacred Heart - Rome, Italy.
Unit of Urology, A.Gemelli Hospital - IRCCS, Catholic University of the Sacred Heart - Rome, Italy.
Clin Genitourin Cancer. 2022 Aug;20(4):e271-e275. doi: 10.1016/j.clgc.2022.03.009. Epub 2022 Mar 16.
EpiCheck is a new urinary test that analyses DNA methylation biomarkers in order to identify high-risk urothelial cancer MATERIALS AND METHODS: A prospective single centre study was performed. We analysed Epicheck results in a population of 231 patients in follow-up for non-muscle invasive bladder cancer. The primary endpoint was to evaluate sensitivity and specificity of Epicheck in detecting any type of bladder cancer recurrence. The secondary endpoint was to evaluate specificity and sensitivity of Epicheck in patients with high-risk recurrence and in patients recently treated with endovesical therapy (< 3 months).
Negative predictive value (NPV) for cytology was 83 % while for bladder Epicheck it was 89 %, while positive predictive value (PPV) was 67 % and 73 % for cytology and Epicheck respectively. Considering only high grade non muscle invasive bladder cancer the sensitivity of Epicheck was 91 % and for cytology was 81 %, specificity was 85 % and 83 % and negative predictive value of Epicheck outreached 96 % compared to 92 % of cytology. Among patients with an ongoing or recent endovesical treatment it appears that sensitivity of Epicheck was 88% % compared to 73 % of cytology, specificity was 97 % and 85 % and NPV was 92 % compared to 82 % for cytology.
The EpiCheck (test showed very high diagnostic values, higher than the currently, gold standard. The test might clinically improve the BCa management in terms of, reduced number of inconclusive/suspicious reports of cytology and endoscopy, reduced number of further examinations, reduced associated patient and economic.
EpiCheck 是一种新的尿液检测方法,可分析 DNA 甲基化生物标志物,以识别高危尿路上皮癌。
进行了一项前瞻性单中心研究。我们分析了 231 例非肌肉浸润性膀胱癌随访患者的 Epicheck 结果。主要终点是评估 Epicheck 在检测任何类型膀胱癌复发方面的敏感性和特异性。次要终点是评估 Epicheck 在高危复发患者和最近接受经尿道治疗(<3 个月)患者中的特异性和敏感性。
细胞学的阴性预测值(NPV)为 83%,而膀胱 Epicheck 的 NPV 为 89%,而细胞学和 Epicheck 的阳性预测值(PPV)分别为 67%和 73%。仅考虑高级别非肌肉浸润性膀胱癌,Epicheck 的敏感性为 91%,而细胞学为 81%,特异性为 85%和 83%,Epicheck 的阴性预测值超过 96%,而细胞学为 92%。在正在进行或最近接受经尿道治疗的患者中,Epicheck 的敏感性为 88%,而细胞学为 73%,特异性为 97%和 85%,NPV 为 92%,而细胞学为 82%。
EpiCheck(测试显示出非常高的诊断价值,高于目前的金标准。该测试可能在临床上通过减少细胞学和内窥镜检查的不确定/可疑报告数量、减少进一步检查的数量、减少相关患者和经济负担,改善 BCa 的管理。