A Study for Assessing the Value of Minimal Residual Disease Detection in Disease Monitoring of CA125 Non-sensitive Ovarian Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The prognostic value of MRD
研究概览
简要总结
Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-75;
- •Pathologically confirmed ovarian cancer;
- •CA125 ≤200U/ml at first diagnosis or recurrence;
- •Physical condition score PS ≤ 2 points;
- •Enough tumor samples for WES detection;
- •Patients and their families can understand and are willing to participate in this study and provide written informed consent.
排除标准
- •Patients unable to provide sufficient tissue / blood samples for research detection;
- •Pregnant or lactating women;
- •Other diseases considered by the research doctor to affect the prognosis and survival;
结局指标
主要结局
The prognostic value of MRD
时间窗: 12 months
The sensitivity of MRD in CA125 low level ovarian patients.
次要结局
- Progress Free Survival(From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months)
研究者
Rutie Yin
West China Second University Hospital
West China Second University Hospital