NCT01309087已完成不适用
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
Allegro Diagnostics, Corp.14 个研究点 分布在 3 个国家目标入组 756 人开始时间: 2009年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 756
- 试验地点
- 14
- 主要终点
- Primary Lung Cancer
研究概览
简要总结
The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy.
- •The patient is undergoing bronchoscopy
- •≥ 21 years of age
- •Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy
- •The patient is a current or former cigarette smoker (defined as having smoked >100 cigarettes in their lifetime.
排除标准
- •The Pulmonary physician does not recommend that bronchoscopy be performed
- •The patient is unable to be consented into the study or unable to comply with requirements of the study
- •The patient has previously been diagnosed with primary lung cancer
- •Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.
结局指标
主要结局
Primary Lung Cancer
时间窗: One year from enrollment
次要结局
未报告次要终点
研究者
研究点 (14)
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