Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis
试验速览
- 阶段
- 不适用
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis
研究概览
简要总结
Methylation detection of circulating free DNA to identify markers for diagnosis and differential diagnosis of ovarian endometriosis.
详细描述
Methylation detection of circulating free DNA and FFPF samples from patients with ovarian endometriosis, ovarian cancer and other benign ovarian cysts will be performed to select markers for ovarian endometriosis diagnosis. The markers will be validated in patients with ovarian cysts found by ultrasound. The diagnosis accuracy of the markers will be evaluated by comparing with the pathological diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •pathologically diagnosed as ovarian endometriosis;
- •surgery was performed in PUMCH
排除标准
- •a. combined with other gynecological benign and malignant tumors; b. clinically suspected malignant tumors; c. combined with other systemic malignancies or malignancies history; d. pregnant patients
- •patients with ovarian cancer:
- •Inclusion Criteria:
- •pathologically diagnosed as epithelial ovarian cancer;
- •surgery was performed in PUMCH
- •Exclusion Criteria:
- •combined with gynecological benign tumors and other malignant tumors;
- •combined with other systemic malignancies or malignancies history;
- •pregnant patients (3) patients with other benign ovarian tumors:
- •Inclusion Criteria:
- •pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis;
- •surgery was performed in PUMCH
- •Exclusion Criteria:
- •a. combined with other gynecological benign and malignant tumors; b. clinically suspected malignant tumors; c. combined with other systemic malignancies or malignancies history; d. pregnant patients
- •Marker validation group:
- •Inclusion Criteria:
- •ovarian cysts found through ultrasound ;
- •surgery will be performed in PUMCH
- •Exclusion Criteria:
- •combined with other gynecological benign and malignant tumors;
- •clinically suspected malignant tumors;
- •combined with other systemic malignancies or malignancies history;
- •pregnant patients
结局指标
主要结局
The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis
时间窗: 12 months
The sensitivity, specificity and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis
次要结局
未报告次要终点
研究者
shuwang
Associate Professor
Peking Union Medical College Hospital