NCT02277366终止不适用
A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Diagnostic yield of Lung Cancer
研究概览
简要总结
The purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400)
- •Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes.
- •The nature of cough changes in a patient who has chronic respiratory disease.
- •Patient has blood-stained sputum persistently or repeatedly without obvious causes.
- •Patient will be included if accorded with any item of above.
排除标准
- •Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
- •Patient has uncontrollable hypertension (SBP > 180mmHg).
- •Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
- •Patient has blood coagulation disorders (PT>2 times the upper limit of normal(ULN) or Platelet(PLT)<50000/ul）.
- •Patient has severe dyspnea.
- •Patient is allergic to local anesthetic.
- •Patient is unable to provide informed consent.
- •Patient is not an appropriate candidate for or is unable to tolerate flexible bronchoscopy procedures.
- •Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
- •Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
- •Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
- •Patient has pulmonary lesions suspected to be cancer from CT images.
- •Female patient of childbearing potential has a positive result from a pregnancy test.
结局指标
主要结局
Diagnostic yield of Lung Cancer
时间窗: 1 week
次要结局
- Number of Participants with Serious Adverse Events(1 week)
研究者
研究点 (1)
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