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临床试验/NCT01309087
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

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

发起方
Allegro Diagnostics, Corp.
申办方类型
Industry
责任方
Sponsor

研究点 (14)

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