NCT00577746已完成不适用
The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Determine the accuracy of EUS in staging NSCLC
研究概览
简要总结
The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject with presumed or known potentially resectable NSCLC
- •Due to the nature of NSCLC, children (<18 year of age) will not be considered
- •Men, women, and minorities
- •Subjects must be able to safely undergo conscious sedation for the EUS procedure
- •Subjects must be surgical candidates
- •Subjects must not have an uncorrectable coagulopathy and must be able to refrain from the used of aspirin one week prior to the EUS
- •Patient must provide signed written informed consent
排除标准
- •Subjects with a history of previously treated lung, head & neck, or esophageal cancer are not eligible if the histologic cell type is determined to be the same as what is biopsied during the EUS-FNA
- •Uncorrectable coagulopathy
- •Significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit their survivability to surgery
- •Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)
- •Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc.) or cardiac condition
- •Evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric illness that would preclude adequate compliance with this protocol
结局指标
主要结局
Determine the accuracy of EUS in staging NSCLC
时间窗: at the end of the study
次要结局
- Measure 5-year survival(5 years)
- Determine the cost benefit of EUS in staging NSCLC(at the end of the study)
- Measure quality of life in patients that undergo surgery(at the end of the study)
研究者
研究点 (1)
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