The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study
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
- Sensitivity of methylation testing
研究概览
简要总结
Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •With uterine and uterine cervix intact
- •Aged 18 years or older
- •With accessible histological results of endometrium
- •Signed an approved informed consents
- •With accessible cervical cytology before harvesting endometrial histology
排除标准
- •Not meeting all of the inclusion criteria
结局指标
主要结局
Sensitivity of methylation testing
时间窗: One week
Sensitivity of methylation testing of cervical cytology compared with histology
Specificity of methylation testing
时间窗: One week
Specificity of methylation testing of cervical cytology compared with histology
次要结局
- Positive predictive value of methylation testing(One week)
- Negative predictive value of methylation testing(One week)
研究者
Lei Li
Professor
Peking Union Medical College Hospital