cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Screening and monitoring the change of cfDNA methylation index
研究概览
简要总结
The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.
详细描述
The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.
The main research content is to screen the cfDNA methylation index that can monitor the efficacy of stage I lung cancer ablation and compare the similarities and differences of cfDNA methylation in patients with stage I lung cancer after surgery and ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-85 years old;
- •The peripheral pulmonary nodules found in patients with chest CT, preoperative examination showed that the clinical stage of patients was T1N0M0, IA;
- •patients are not suitable for surgical treatment through multidisciplinary assessment, agree to accept ablation
- •Patients have good compliance with the tests and follow-ups, understand the situation of the study and sign informed consent.
排除标准
- •The patient is generally in poor condition and cannot tolerate the examination;
- •patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the lungs are adjacent to large blood vessels or important structures;
- •patients with poor compliance;
- •Researchers believe that it is not appropriate to participate in this trial.
结局指标
主要结局
Screening and monitoring the change of cfDNA methylation index
时间窗: before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month
Screening and monitoring the change of cfDNA methylation index in patients with stage I lung cancer after ablation
次要结局
- Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation(before surgery , after surgery 1month, 3month)
研究者
Jiayuan Sun
Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology
Shanghai Chest Hospital