Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Detection of genetic alterations (including EGFR and ALK) in plasma samples
研究概览
简要总结
The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
- •Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
- •Patients must have given written informed consent
排除标准
- •Patients who refuse the blood samplings
结局指标
主要结局
Detection of genetic alterations (including EGFR and ALK) in plasma samples
时间窗: 60 months
To evaluate the sensitivity of digital PCR to detect the genetic alterations in plasma tumor DNA
次要结局
- Quantifying circulating tumor DNA in serially collected plasma specimens(60 months)
研究者
Hyun Chang
Assistant Professor
Seoul National University Hospital