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

NCT04079400 | Completed DMC

• 1 other identifier: 2016-5205
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis, Pulmonary; Non-Tuberculous Mycobacterial Pneumonia; Lung Cancer; Hemoptysis

Outcome Measures

Primary Outcomes (1)

• 16S rRNA sequencing

  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)

Study Arms (5)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Related Publications (12)

• Caverly LJ, Carmody LA, Haig SJ, Kotlarz N, Kalikin LM, Raskin L, LiPuma JJ. Culture-Independent Identification of Nontuberculous Mycobacteria in Cystic Fibrosis Respiratory Samples. PLoS One. 2016 Apr 19;11(4):e0153876. doi: 10.1371/journal.pone.0153876. eCollection 2016.

  PMID: 27093603 BACKGROUND

• Green H, Jones AM. The microbiome and emerging pathogens in cystic fibrosis and non-cystic fibrosis bronchiectasis. Semin Respir Crit Care Med. 2015 Apr;36(2):225-35. doi: 10.1055/s-0035-1546752. Epub 2015 Mar 31.

  PMID: 25826590 BACKGROUND

• Tunney MM, Einarsson GG, Wei L, Drain M, Klem ER, Cardwell C, Ennis M, Boucher RC, Wolfgang MC, Elborn JS. Lung microbiota and bacterial abundance in patients with bronchiectasis when clinically stable and during exacerbation. Am J Respir Crit Care Med. 2013 May 15;187(10):1118-26. doi: 10.1164/rccm.201210-1937OC.

  PMID: 23348972 BACKGROUND

• Yu G, Gail MH, Consonni D, Carugno M, Humphrys M, Pesatori AC, Caporaso NE, Goedert JJ, Ravel J, Landi MT. Characterizing human lung tissue microbiota and its relationship to epidemiological and clinical features. Genome Biol. 2016 Jul 28;17(1):163. doi: 10.1186/s13059-016-1021-1.

  PMID: 27468850 BACKGROUND

• Philley JV, Kannan A, Olusola P, McGaha P, Singh KP, Samten B, Griffith DE, Dasgupta S. Microbiome Diversity in Sputum of Nontuberculous Mycobacteria Infected Women with a History of Breast Cancer. Cell Physiol Biochem. 2019;52(2):263-279. doi: 10.33594/000000020. Epub 2019 Feb 28.

  PMID: 30816674 RESULT

• Cheung MK, Lam WY, Fung WY, Law PT, Au CH, Nong W, Kam KM, Kwan HS, Tsui SK. Sputum microbiota in tuberculosis as revealed by 16S rRNA pyrosequencing. PLoS One. 2013;8(1):e54574. doi: 10.1371/journal.pone.0054574. Epub 2013 Jan 24.

  PMID: 23365674 RESULT

• Adami AJ, Cervantes JL. The microbiome at the pulmonary alveolar niche and its role in Mycobacterium tuberculosis infection. Tuberculosis (Edinb). 2015 Dec;95(6):651-658. doi: 10.1016/j.tube.2015.07.004. Epub 2015 Jul 30.

  PMID: 26455529 RESULT

• Lee SH, Sung JY, Yong D, Chun J, Kim SY, Song JH, Chung KS, Kim EY, Jung JY, Kang YA, Kim YS, Kim SK, Chang J, Park MS. Characterization of microbiome in bronchoalveolar lavage fluid of patients with lung cancer comparing with benign mass like lesions. Lung Cancer. 2016 Dec;102:89-95. doi: 10.1016/j.lungcan.2016.10.016. Epub 2016 Oct 31.

  PMID: 27987594 RESULT

• Yan X, Yang M, Liu J, Gao R, Hu J, Li J, Zhang L, Shi Y, Guo H, Cheng J, Razi M, Pang S, Yu X, Hu S. Discovery and validation of potential bacterial biomarkers for lung cancer. Am J Cancer Res. 2015 Sep 15;5(10):3111-22. eCollection 2015.

  PMID: 26693063 RESULT

• Vogtmann E, Goedert JJ. Epidemiologic studies of the human microbiome and cancer. Br J Cancer. 2016 Feb 2;114(3):237-42. doi: 10.1038/bjc.2015.465. Epub 2016 Jan 5.

  PMID: 26730578 RESULT

• Hosgood HD 3rd, Sapkota AR, Rothman N, Rohan T, Hu W, Xu J, Vermeulen R, He X, White JR, Wu G, Wei F, Mongodin EF, Lan Q. The potential role of lung microbiota in lung cancer attributed to household coal burning exposures. Environ Mol Mutagen. 2014 Oct;55(8):643-51. doi: 10.1002/em.21878. Epub 2014 Jun 3.

  PMID: 24895247 RESULT

• Liu HX, Tao LL, Zhang J, Zhu YG, Zheng Y, Liu D, Zhou M, Ke H, Shi MM, Qu JM. Difference of lower airway microbiome in bilateral protected specimen brush between lung cancer patients with unilateral lobar masses and control subjects. Int J Cancer. 2018 Feb 15;142(4):769-778. doi: 10.1002/ijc.31098. Epub 2017 Nov 8.

  PMID: 29023689 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lower respiratory specimens acquired by bronchial brushing and washing for 16S rRNA sequencing

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Lung Neoplasms; Hemoptysis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Sang Min Lee, MD, PhD

  Gachon Univ. Gil Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: December 1, 2016
• Primary Completion: October 30, 2018
• Study Completion: April 11, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share