Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
CtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .
详细描述
CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative histopathological diagnosis of TNM stage IA / IB NSCLC with R0 resection;
- •No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
- •General selection criteria:
- •Men or women of age ≥18 years and <75 years old;
- •ECOG behavior status score 0 to 1;
排除标准
- •Patients with other cancers other than NSCLC within five years prior to this study;
- •who can not get enough tumor histological specimens (non-cytological) for analysis;
- •human immunodeficiency virus (HIV) infection;
- •NSCLC mixed with patients with small cell lung cancer;
- •pregnant or lactating women;
- •There is a clear history of neurological or mental disorders, including epilepsy or dementia;
- •Conditions that investigators think is not suitable for inclusion.
结局指标
主要结局
Disease-free survival
时间窗: 2 years after the last patient enrolled
Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause
次要结局
- Overall survival(5 years after the last patient enrolled)
研究者
Si-Yu Wang
professor
Sun Yat-sen University