Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- The sensitivity and specificity of methylation test in detecting CIN2+.
研究概览
简要总结
The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.
详细描述
The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 25~65 years undergoing cervical cancer screening
- •normal for cytology and positive for hrHPV
- •informed consent was obtained
排除标准
- •with a known history of ablation or treatment with cervical excision within 12 months
- •hysterectomy
- •chemoradiotherapy
- •planning to participate or taking part in another cancer screening, treatment, or vaccination study
- •do not meet the inclusion criteria
- •give up the trial or naturally dropped out of the follow-up during the observation process
- •people who asked to withdraw
结局指标
主要结局
The sensitivity and specificity of methylation test in detecting CIN2+.
时间窗: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months
The primary variable of methylation test are as follows:clinical sensitivity, clinical specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, positive coincidence rate, and negative coincidence rate.
次要结局
- KAPPA value of methylation test.(From date of enrollment until the date of first documented CIN2+,assessed up to 12 months)