ClinicalTrials.Veeva

Menu

Microbiome in Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases, Lung Cancer and Hemoptysis

G

Gachon University Gil Medical Center

Status

Completed

Conditions

Non-Tuberculous Mycobacterial Pneumonia
Tuberculosis, Pulmonary
Hemoptysis
Lung Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04079400
2016-5205

Details and patient eligibility

About

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.

Full description

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.

Enrollment

43 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

43 participants in 5 patient groups

Tb group
Description:
Subjects who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis (Tb) observed on chest computed tomography
NTM-PD group
Description:
Subjects who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography
LC group
Description:
Subjects who underwent bronchoscopy for suspicious endobronchial lung cancer (LC) observed on chest computed tomography
HM group
Description:
Subjects who underwent bronchoscopy for hemoptysis
Control group
Description:
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.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems