Microbiome in Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases, Lung Cancer and Hemoptysis
NCT ID: NCT04079400
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2016-12-01
2019-04-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Tb group
Subjects who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis (Tb) observed on chest computed tomography
No interventions assigned to this group
NTM-PD group
Subjects who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography
No interventions assigned to this group
LC group
Subjects who underwent bronchoscopy for suspicious endobronchial lung cancer (LC) observed on chest computed tomography
No interventions assigned to this group
HM group
Subjects who underwent bronchoscopy for hemoptysis
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of any antibiotic within a month
* Vulnerable volunteer
* Subject's rejection
19 Years
ALL
No
Sponsors
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Gachon University Gil Medical Center
OTHER
Responsible Party
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Sangmin Lee, MD
Associate professor
Principal Investigators
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Sang Min Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gachon Univ. Gil Medical Center
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2016-5205
Identifier Type: -
Identifier Source: org_study_id
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