Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of p16 protein expression
研究概览
简要总结
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Signed an approved informed consents
- •With sufficient cytology sample for p16 testing
- •With definite results of cytology and/or high-risk human papillomavirus and cervical histology
排除标准
- •Not meeting all of the inclusion criteria
结局指标
主要结局
Diagnostic accuracy of p16 protein expression
时间窗: Two years
Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
次要结局
未报告次要终点
研究者
Lei Li
Professor
Peking Union Medical College Hospital