Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China
试验速览
- 阶段
- 2 期
- 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 epithelial ovarian cancer
研究概览
简要总结
Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages.
In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues.
In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors.
In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC 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
- Non Randomized
- 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 epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
- •With sufficient fresh peripheral serum and ovarian 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 epithelial ovarian cancer
时间窗: Two years
The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.
次要结局
- Accuracy of serum DNA methylation in epithelial ovarian cancer(Two years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital