Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,935
- 试验地点
- 1
- 主要终点
- To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
研究概览
简要总结
This study is a prospective study aimed to validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935 female participants, including participants with gynecologic cancers patients and healthy participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
时间窗: 24 months
次要结局
- To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors(24months)
- To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.(24months)
研究者
Zhong Zheng MD
Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
Fudan University
