Performance of a new HPV and biomarker assay in the management of hrHPV positive women: Subanalysis of the ongoing multicenter TRACE clinical trial (n > 6,000) to evaluate POU4F3 methylation as a potential biomarker of cervical precancer and cancer

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• 作者：Adrienn Kocsis ; Tibor Taká ; cs ; Csaba Jeney ; Zsuzsa Schaff ; Ró ; bert Koiss ; Balá ; zs Já ; ray ; Gá ; bor Sobel ; Ká ; roly Pap ; Istvá ; n Szé ; kely ; Tamá ; s Ferenci ; Hung-Cheng Lai ; Mikló ; s Nyí ; ri and Má ; rta Benczik
• 刊名：International Journal of Cancer
• 出版年：2017
• 出版时间：1 March 2017
• 年：2017
• 卷：140
• 期：5
• 页码：1119-1133
• 全文大小：532K
• ISSN：1097-0215

文摘

The ongoing Triage and Risk Assessment of Cervical Precancer by Epigenetic Biomarker (TRACE) prospective, multicenter study aimed to provide a clinical evaluation of the CONFIDENCE™ assay, which comprises a human papillomavirus (HPV) DNA and a human epigenetic biomarker test. Between 2013 and 2015 over 6,000 women aged 18 or older were recruited in Hungary. Liquid-based cytology (LBC), high-risk HPV (hrHPV) DNA detection and single target host gene methylation test of the promoter sequence of the POU4F3 gene by quantitative methylation-specific polymerase chain reaction (PCR) were performed from the same liquid-based cytology sample. The current analysis is focused on the baseline cross-sectional clinical results of 5,384 LBC samples collected from subjects aged 25 years or older. The performance of the CONFIDENCE HPV™ test was found to be comparable to the cobas® HPV test with good agreement. When applying the CONFIDENCE Marker™ test alone in hrHPV positives, it showed significantly higher sensitivity with matching specificity compared to LBC-based triage. For CIN3+ histological endpoint in the age group of 25–65 and 30–65, the methylation test of POU4F3 achieved relative sensitivities of 1.74 (95% CI: 1.25–2.33) and 1.64 (95% CI: 1.08–2.27), respectively, after verification bias adjustment. On the basis of our findings, POU4F3 methylation as a triage test of hrHPV positives appears to be a noteworthy method. We can reasonably assume that its quantitative nature offers the potential for a more objective and discriminative risk assessment tool in the prevention and diagnostics of high-grade cervical intraepithelial neoplasia (CIN) lesions and cervical cancer.