Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.
研究概览
简要总结
To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.
详细描述
Some studies have shown the potential of ctDNA in renal cancer monitoring, but the amount of ctDNA released in renal cancer is the lowest among non-cranial tumors. Even in advanced patients, the detection rate of tumor system mutation is less than 50%. DNA methylation is important in the process of tumor occurrence and development. However, no studies have focused on the value of ctDNA methylation in monitoring renal cancer, nor have large prospective cohort studies been conducted in patients with renal cancer.
This study intended to analyze the dynamic changes of circulating tumor DNA and its methylation status in patients with kidney cancer from preoperative to long-term follow-up, and to compare the evaluation value of methylation detection with traditional imaging examination and traditional blood tumor markers in the monitoring process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed renal cell carcinoma
- •Without any treatment
- •Agree and accept radical surgical treatment
- •Signed written informed consent
- •ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1
- •Follow up protocol and related procedures
排除标准
- •Had other cancers
- •Had received any antitumor therapy before
- •Known or suspected active autoimmune disease
- •Informed consent is not possible due to medical or psychiatric problems
- •Have clinical symptoms or diseases of the heart that are not well controlled
- •Patients judged by the investigators to be unsuitable for inclusion in this study
结局指标
主要结局
To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.
时间窗: 5 years
To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.
时间窗: 5 years
The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.
时间窗: 5 years
A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics
时间窗: 5 years
次要结局
未报告次要终点
研究者
Le Qu
Associate chief urologist
Jinling Hospital, China