Background/Objectives: Most cervical intraepithelial neoplasias (CINs) regress over time. Diagnostic screenings are limited and cannot identify the disease trend, which leads to the risk of overtreatment. Reliable methods are needed to preselect patients who will probably progress. The diagnostic GynTect®assay offers sensitive and specific CIN identification from cervical scrapes, measuring the methylation of six marker genes. We studied the main marker (ZNF671) methylation on formalin-fixed paraffin-embedded (FFPE) material to determine if the kit provides prognostic information too. Methods: We tested 289 FFPE samples from 139 patients with varying CIN grades and disease trends, including regressive, persistent, progressive, and recurrent disease. Additionally, we correlated age and human papillomavirus (HPV) status with the results. Results: Although there are differences between FFPE material and cervical scrapes, we achieved a similar increase inZNF671methylation with increasing neoplasia grade (dysplasia-free: 0%, CIN 1: 8.20%, CIN 2: 26.73%, CIN 3: 32.43%, carcinoma: 100%). In addition,ZNF671is more likely to detect recurring (27.12% of positives) and progressive (59.32% of positives) neoplasia. Patients with regressive (1.69% of positives) or persistent (11.86% of positives) trends less frequently showZNF671methylation. Interestingly, patients with HPV 16 infection (52.54% of positives) and >30 years (89.83% of positives) are more likely to appearZNF671methylation-positive. However, patients < 30 years with persistent neoplasia (42.86% of positives) also show methylation more frequently. Conclusions: The methylation ofZNF671is measurable in cervical FFPE material and has prognostic value. SinceZNF671-methylated samples are most likely to be progressing, we recommend the closer monitoring of patients with GynTect®-positive test results.
背景/目的：大多数宫颈上皮内瘤变（CIN）会随时间自然消退。现有诊断筛查手段有限，无法识别疾病发展趋势，导致过度治疗风险。因此需要可靠的方法来预判可能进展的患者。GynTect®检测试剂盒通过测量六个标记基因的甲基化水平，能够从宫颈刮片中灵敏且特异地识别CIN。本研究旨在通过分析福尔马林固定石蜡包埋（FFPE）组织中主要标记基因ZNF671的甲基化状态，探究该试剂盒是否同时具备预后评估价值。方法：我们检测了139例不同CIN分级及疾病发展趋势（包括消退型、持续型、进展型和复发型）患者的289份FFPE样本，并分析了年龄与人乳头瘤病毒（HPV）状态与检测结果的相关性。结果：尽管FFPE材料与宫颈刮片存在差异，但我们观察到ZNF671甲基化水平随瘤变级别升高而增加的趋势与前期研究一致（无异型增生：0%，CIN 1：8.20%，CIN 2：26.73%，CIN 3：32.43%，癌变：100%）。此外，ZNF671甲基化更易检测到复发型（阳性率27.12%）和进展型（阳性率59.32%）瘤变，而消退型（阳性率1.69%）或持续型（阳性率11.86%）病变的甲基化频率较低。值得注意的是，HPV 16感染者（阳性率52.54%）和年龄＞30岁者（阳性率89.83%）更易出现ZNF671甲基化阳性。但年龄＜30岁的持续型瘤变患者（阳性率42.86%）也显示出较高的甲基化频率。结论：ZNF671甲基化可在宫颈FFPE材料中检测，并具有预后价值。鉴于ZNF671甲基化样本最可能进展，我们建议对GynTect®检测结果阳性的患者加强随访监测。
肿瘤(癌症)患者之家