NCT01799382已完成不适用
Mutational Analysis of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Specimens in Patients With Advanced Non-small Cell Lung Cancer: a Randomized Trial of Rapid On-site Evaluation
Maggiore Bellaria Hospital, Bologna2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes
研究概览
简要总结
The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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 years
- •Suspected hilar or mediastinal lymph node metastasis from lung cancer
排除标准
- •Pregnancy
- •Uncontrolled coagulopathy
- •Refusal to sign informed consent
结局指标
主要结局
Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes
时间窗: 18 months
Percentage of patients for whom the mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes on EBUS-TBNA samples is obtained
次要结局
- Diagnostic yield of EBUS-TBNA(18 months)
- Adequacy of EBUS-TBNA samples(18 months)
研究者
Rocco Trisolini
M.D.
Maggiore Bellaria Hospital, Bologna
研究点 (2)
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