Microbiome in Patients With Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases (NTM-PD), Lung Cancer and Hemoptysis
Sponsor study identifier
observational
43
0 countries
N/A
Study Start
December 1, 2016
Actual (reported)Primary Completion
October 30, 2018
Actual (reported)Study Completion
April 11, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 11, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2016
Actual (reported)October 30, 2018
Actual (reported)April 11, 2019
Actual (reported)September 3, 2019
Actual (reported)September 6, 2019
Actual (reported)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)
Subjects who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis (Tb) observed on chest computed tomography
Subjects who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography
Subjects who underwent bronchoscopy for suspicious endobronchial lung cancer (LC) observed on chest computed tomography
Subjects who underwent bronchoscopy for hemoptysis
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.
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
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.
Lower respiratory specimens acquired by bronchial brushing and washing for 16S rRNA sequencing
Sang Min Lee, MD, PhD
Gachon Univ. Gil Medical Center
43 participants (actual enrollment reported by the registry).
First Submitted
September 3, 2019
First Posted
September 6, 2019
Study Start
December 1, 2016
Actual (reported)Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia
Contact the study team to confirm eligibility.
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.
Primary Completion
October 30, 2018
Actual (reported)Study Completion
April 11, 2019
Actual (reported)Last Updated
September 6, 2019
Record last verified: 2019-09
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.
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Source: ClinicalTrials.gov.
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