An observational study in Tuberculosis, Pulmonary, Non-Tuberculous Mycobacterial Pneumonia and Lung Cancer, sponsored by Gachon University Gil Medical Center. Completed. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Gachon University Gil Medical Center · Observational
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.
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.
In hemoptysis group, bronchial washing was done in bronchus of ongoing bleeding.
In control group, specimens of bronchial mucosa in predetermined random bronchus (not bronchus with suspicious endobronchial lesion) with PB. After acquiring respiratory specimens of PB, bronchial washing was done in the same bronchus.
Microbiome in lower respiratory species was analyzed using 16S rRNA sequencing.
HM group
Tb group
NTM-PD group
LC group
Control group
Exclusion Criteria:
Subjects who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis (Tb) observed on chest computed tomography
Subjects who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography
Subjects who underwent bronchoscopy for suspicious endobronchial lung cancer (LC) observed on chest computed tomography
Subjects who underwent bronchoscopy for hemoptysis
Subjects who underwent bronchoscopy to rule out endobronchial lesion observed on chest computed tomography. Endbronchial lesion should not be typical for any category of respiratory diseases including tuberculosis, NTM-TB and lung cancer.
16S rRNA sequencing
The V1 to V3 regions of the 16S rRNA in respiratory specimens were analyzed for identification of microbiomes.
Time frame: 0 day (the day of study enrollment)
No study locations are listed for this record.
Plan to share: No — Technically, results of 16S rRNA sequencing can hardly be shared. Study protocol, SAP, ICF, CSR were written in Korean, so they can not be shared either.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Gachon University Gil Medical Center