Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cut-off values of targeted DNA methylation in endometrial cancer
研究概览
简要总结
Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.
In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.
In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.
In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
- •With sufficient fresh peripheral serum, cervical cytology, and endometrial samples for DNA methylation testing before with or without after major surgeries.
- •Aged 18 years or older.
- •Signed an approved informed consents
排除标准
- •Not meeting all of the inclusion criteria.
结局指标
主要结局
Cut-off values of targeted DNA methylation in endometrial cancer
时间窗: Two years
The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients
次要结局
- Accuracy of serum DNA methylation in endometrial cancer(Two years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital