Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,331
- 试验地点
- 21
- 主要终点
- Lung Cancer Diagnosis (positive or negative)
研究概览
简要总结
The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.
详细描述
Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.
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
- •Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
- •All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
- •Patient must be a current or former cigarette smoker
排除标准
- •A pulmonary physician does not recommend that bronchoscopy be performed
- •Inability to understand the written consent form and comply with requirements of the study
- •History of prior 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
Lung Cancer Diagnosis (positive or negative)
时间窗: 12 months
Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.
次要结局
未报告次要终点