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

September 3, 2019 updated by: Sangmin Lee, MD, Gachon University Gil Medical Center

Microbiome in Patients With Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases (NTM-PD), Lung Cancer and Hemoptysis

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

43

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. HM group

    • Patients who underwent bronchoscopy for hemoptysis

  2. Tb group

    • Patients who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis

  3. NTM-PD group

    • Patients who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD)

  4. LC group

    • Patients who underwent bronchoscopy for suspicious endobronchial lung cancer

  5. Control group

    • 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16S rRNA sequencing
Time Frame: 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.
0 day (the day of study enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

April 11, 2019

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-5205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe