A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- ctDNA leading time
研究概览
简要总结
Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.
详细描述
The study consists of two phases, the first stage is the exploratory stage of blood collection point which is the appropriate effective time after chemotherapy, radiotherapy, targeted therapy. The second phase, which is the expansion of the first phase, is to determine the precise leading time of ctDNA relative to tumor biomarkers or image evaluation in determining the efficacy of advanced NSCLC cancer therapy. Both stages were divided into three subgroups: the chemotherapy group, the radiotherapy group, and the targeted therapy group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years old;
- •Patients with stage III-IV NSCLC;
- •Have the tissue specimens (fresh or wax blocks) before this treatment;
- •PS<=2 in radiotherapy/ chemotherapy group; PS<=3 in targeted therapy group
- •Signing informed consent;
排除标准
- •Multiple primary lung cancer;
- •Incorporating any unstable systemic disease;
- •Histology is not NSCLC;
- •Unqualified blood samples;
- •Patients lacking any one of the detection points.
结局指标
主要结局
ctDNA leading time
时间窗: 1 year
To investigate the precise leading time for ctDNA compared to conventional biomarker or image evaluation in detecting disease recurrence after radiotherapy, chemotherapy, or targeted therapy respectively.
ctDNA effective time
时间窗: 6 months
To explore the appropriate chemo/ radio/ target effective time (CET/RET/TET) through measurement and monitoring of ctDNA after anti-cancer therapies in advanced NSCLC.
次要结局
- Compared to conventional image(1 year)
- Compared to traditional tumor markers(6 months)
- Assess the accuracy of ctDNA(1 year)