NCT01767974Unknown不适用
Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Detection rate of EGFR mutation
研究概览
简要总结
Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.
详细描述
Single arm, open label, prospective, observational study of gefitinib treatment for locally advanced (stage IIIB) or IV (metastatic) or relapsed NSCLC patients.
Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.
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
- •Locally advanced stage IIIB not suitable for curative therapy or stage IV (metastatic) disease or relapsed NSCLC
- •ECOG Performance status 0~
- •Written Informed Consent
- •Female or male patients aged 18 years or over, eligible for treatment for NSCLC
排除标准
- •Previous exposure to EGFR-TKI
- •Concomitant use of other anti-cancer drugs with EGFR-TKI
- •Patients without available Tumor DNA
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- •Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
结局指标
主要结局
Detection rate of EGFR mutation
时间窗: two weeks
To prove higher detection rate of EGFR mutation with PNA clamping compared with sequencing
次要结局
- Verification of PNA positive casese(Two weeks)
研究者
Young-Chul Kim
Professor
Chonnam National University Hospital
研究点 (1)
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