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

Sponsor
Gachon University Gil Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04079400
Collaborator
(none)
43
28.3

Study Details

Study Description

Brief Summary

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.

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
43 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Microbiome in Patients With Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases (NTM-PD), Lung Cancer and Hemoptysis
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Apr 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Tb group

Subjects who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis (Tb) observed on chest computed tomography

NTM-PD group

Subjects who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography

LC group

Subjects who underwent bronchoscopy for suspicious endobronchial lung cancer (LC) observed on chest computed tomography

HM group

Subjects who underwent bronchoscopy for hemoptysis

Control group

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.

Outcome Measures

Primary Outcome Measures

  1. 16S rRNA sequencing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gachon University Gil Medical Center

Investigators

  • Principal Investigator: Sang Min Lee, MD, PhD, Gachon Univ. Gil Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sangmin Lee, MD, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT04079400
Other Study ID Numbers:
  • 2016-5205
First Posted:
Sep 6, 2019
Last Update Posted:
Sep 6, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 6, 2019