Microbiome in Patients With Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases (NTM-PD), Lung Cancer and Hemoptysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- 16S rRNA sequencing
研究概览
简要总结
Microbiome in lower respiratory diseases is not sufficiently known yet. The objective of this study is to investigate microbiome in patients who present with hemoptysis, and those with pulmonary tuberculosis, non-tuberculous mycobacterial pulmonary disease (NTM-PD), and lung cancer, analyzing respiratory specimen acquired by bronchoscopic approach.
详细描述
Subjects who were going to undergo bronchoscopy for hemoptysis or suspected lower respiratory diseases including endobronchial tuberculosis (Tb), NTM-PD, or endobronchial lung cancer (LC) were enrolled after informed consents.
Subjects who were supposed to receive bronchoscopy to rule out endobronchial lesions were also enrolled as control group (ctrl) after informed consents. In those control group, endobronchial tuberculosis, malignancy or other certain respiratory diseases was not clearly suspected.
Before acquiring respiratory specimens, bronchoscopic channels were washed to acquire negative control in all cases of groups.
In Tb group and LC group, specimens of normal bronchial mucosa near suspicious endobronchial lesion were obtained with protected brush (PB), then specimens of abnormal bronchial mucosa in suspicious endobronchial lesion with PB. After acquiring respiratory specimens of PB, bronchial washing was done in suspicious endobronchial lesion.
In NTM-PD group, specimens of bronchial mucosa in bronchus of suspicious NTM-PD with PB. After acquiring respiratory specimens of PB, bronchial washing was done in bronchus of suspicious NTM-PD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent bronchoscopy for hemoptysis, OR
- •Patients who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis observed on chest computed tomography, OR
- •Patients who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography, OR
- •Patients who underwent bronchoscopy for suspicious endobronchial lung cancer observed on chest computed tomography, OR
- •Patients who underwent bronchoscopy to rule out endobronchial lesion which did not seem to be typical for any criteria of pulmonary diseases including tuberculosis, NTM-PD or lung cancer on chest computed tomography
排除标准
- •Other malignancy, infection or serious diseases of neural, cardiovascular, renal, hepatobiliary, gastrointestinal, hemotologic or respiratory system
- •Use of any antibiotic within a month
- •Vulnerable volunteer
- •Subject's rejection
结局指标
主要结局
16S rRNA sequencing
时间窗: 0 day (the day of study enrollment)
The V1 to V3 regions of the 16S rRNA in respiratory specimens were analyzed for identification of microbiomes.
次要结局
未报告次要终点
研究者
Sangmin Lee, MD
Associate professor
Gachon University Gil Medical Center