Nontuberculosis Mycobacterial Lung DiseaseKorean NTMNCT01616745
Phenotypic Clinical, and Genetic Characteristics of Patients With Nontuberculosis Mycobacteria
An observational study of Nontuberculosis Mycobacterial Lung Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics of Korean Nontuberculosis Mycobacteria (NTM) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nontuberculosis Mycobacterial Lung Disease
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: persons met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
Who may be able to join
- Persons met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
Who cannot join
- Already on treatment for NTM lung disease
- Appropriate exclusion of other lung diagnosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jae-Joon Yim, MD, 82-2-2072-2059, yimjj@snu.ac.kr
Ae-Ra Lee, MD, 82-31-787-2455, drmom@paran.com
About this study
Official title: Characteristics of Patients With Nontuberculosis Mycobacteria in Korean Population
The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics of Korean Nontuberculosis Mycobacteria (NTM) patients.
Read the detailed description
To elucidate phenotypic, clinical, and genetic characteristics of Korean NTM patients.
Especially, to compare body mass index, positive rate of IGRA, and CFTR mutation with general Korean population.
- Keywords
- NTM Lung disease, NTM Lung disease patients enrolled in SNUH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJul 2011
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nontuberculosis Mycobacterial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Joon Yim, Seoul National University Hospital
- Investigators
- Jae-Joon Yim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616745
- Sponsor's protocol ID
- H-1103-057-355
- Acronym
- Korean NTM
- Status last verified
- Jun 2012
- First submitted
- 25 Mar 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hyung K, Kim SA, Kwak N, Yim JJ, Kim JY. Clinically significant hemoptysis and all-cause mortality in patients with nontuberculous mycobacterial pulmonary disease. Respir Med. 2025 Feb;237:107946. doi: 10.1016/j.rmed.2025.107946. Epub 2025 Jan 8.
PubMed 39793860Hyung K, Kim SA, Kim JY, Kwak N, Yim JJ. Rates and Risk Factors of Progression in Patients With Nontuberculous Mycobacterial Pulmonary Disease: Secondary Analysis of a Prospective Cohort Study. Chest. 2024 Sep;166(3):452-460. doi: 10.1016/j.chest.2024.03.024. Epub 2024 Mar 16.
PubMed 38499238Kwak N, Park J, Kim SJ, Kim JY, Kim TS, Yoon JK, Whang J, Lee W, Shin SJ, Yim JJ. Genetic stability of Mycobacterium abscessus during antibiotic treatment. J Glob Antimicrob Resist. 2024 Mar;36:45-49. doi: 10.1016/j.jgar.2023.12.004. Epub 2023 Dec 19.
PubMed 38128724Jung HI, Kim SA, Kim HJ, Yim JJ, Kwak N. Anxiety and Depression in Patients With Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study in South Korea. Chest. 2022 Apr;161(4):918-926. doi: 10.1016/j.chest.2021.10.024. Epub 2021 Oct 28.
PubMed 34756943Kwak N, Lee JH, Kim HJ, Kim SA, Yim JJ. New-onset nontuberculous mycobacterial pulmonary disease in bronchiectasis: tracking the clinical and radiographic changes. BMC Pulm Med. 2020 Nov 10;20(1):293. doi: 10.1186/s12890-020-01331-3.
PubMed 33172424Kwak N, Whang J, Yang JS, Kim TS, Kim SA, Yim JJ. Minimal Inhibitory Concentration of Clofazimine Among Clinical Isolates of Nontuberculous Mycobacteria and Its Impact on Treatment Outcome. Chest. 2021 Feb;159(2):517-523. doi: 10.1016/j.chest.2020.07.040. Epub 2020 Jul 24.
PubMed 32712225Kwak N, Kim SA, Choi SM, Lee J, Lee CH, Yim JJ. Longitudinal changes in health-related quality of life according to clinical course among patients with non-tuberculous mycobacterial pulmonary disease: a prospective cohort study. BMC Pulm Med. 2020 May 7;20(1):126. doi: 10.1186/s12890-020-1165-3.
PubMed 32381080Kim HJ, Lee JH, Yoon SH, Kim SA, Kim MS, Choi SM, Lee J, Lee CH, Han SK, Yim JJ. Nontuberculous mycobacterial pulmonary disease diagnosed by two methods: a prospective cohort study. BMC Infect Dis. 2019 May 24;19(1):468. doi: 10.1186/s12879-019-4078-0.
PubMed 31126235Kim SJ, Yoon SH, Choi SM, Lee J, Lee CH, Han SK, Yim JJ. Characteristics associated with progression in patients with of nontuberculous mycobacterial lung disease : a prospective cohort study. BMC Pulm Med. 2017 Jan 5;17(1):5. doi: 10.1186/s12890-016-0349-3.
PubMed 28056937Lee AR, Lee J, Choi SM, Seong MW, Kim SA, Kim M, Chae KO, Lee JS, Yim JJ. Phenotypic, immunologic, and clinical characteristics of patients with nontuberculous mycobacterial lung disease in Korea. BMC Infect Dis. 2013 Nov 25;13:558. doi: 10.1186/1471-2334-13-558.
PubMed 24274658
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Nontuberculosis Mycobacteria in Korean Population
- ClinicalTrials.gov ID
- NCT01616745
- Acronym / sponsor ID
- Korean NTM / H-1103-057-355
- Keywords
- NTM Lung disease, NTM Lung disease patients enrolled in SNUH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Study completion
- Feb 2021 (estimated)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics of Korean Nontuberculosis Mycobacteria (NTM) patients.
Detailed description
To elucidate phenotypic, clinical, and genetic characteristics of Korean NTM patients.
Especially, to compare body mass index, positive rate of IGRA, and CFTR mutation with general Korean population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- persons met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
Key inclusion criteria (1 listed)
- Persons met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
Key exclusion criteria (2 listed)
- Already on treatment for NTM lung disease
- Appropriate exclusion of other lung diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
- Derived from this study: PubMed 39793860Hyung K, Kim SA, Kwak N, Yim JJ, Kim JY. Clinically significant hemoptysis and all-cause mortality in patients with nontuberculous mycobacterial pulmonary disease. Respir Med. 2025 Feb;237:107946. doi: 10.1016/j.rmed.2025.107946. Epub 2025 Jan 8.
- Derived from this study: PubMed 38499238Hyung K, Kim SA, Kim JY, Kwak N, Yim JJ. Rates and Risk Factors of Progression in Patients With Nontuberculous Mycobacterial Pulmonary Disease: Secondary Analysis of a Prospective Cohort Study. Chest. 2024 Sep;166(3):452-460. doi: 10.1016/j.chest.2024.03.024. Epub 2024 Mar 16.
- Derived from this study: PubMed 38128724Kwak N, Park J, Kim SJ, Kim JY, Kim TS, Yoon JK, Whang J, Lee W, Shin SJ, Yim JJ. Genetic stability of Mycobacterium abscessus during antibiotic treatment. J Glob Antimicrob Resist. 2024 Mar;36:45-49. doi: 10.1016/j.jgar.2023.12.004. Epub 2023 Dec 19.
- Derived from this study: PubMed 34756943Jung HI, Kim SA, Kim HJ, Yim JJ, Kwak N. Anxiety and Depression in Patients With Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study in South Korea. Chest. 2022 Apr;161(4):918-926. doi: 10.1016/j.chest.2021.10.024. Epub 2021 Oct 28.
- Derived from this study: PubMed 33172424Kwak N, Lee JH, Kim HJ, Kim SA, Yim JJ. New-onset nontuberculous mycobacterial pulmonary disease in bronchiectasis: tracking the clinical and radiographic changes. BMC Pulm Med. 2020 Nov 10;20(1):293. doi: 10.1186/s12890-020-01331-3.
- Derived from this study: PubMed 32712225Kwak N, Whang J, Yang JS, Kim TS, Kim SA, Yim JJ. Minimal Inhibitory Concentration of Clofazimine Among Clinical Isolates of Nontuberculous Mycobacteria and Its Impact on Treatment Outcome. Chest. 2021 Feb;159(2):517-523. doi: 10.1016/j.chest.2020.07.040. Epub 2020 Jul 24.
- Derived from this study: PubMed 32381080Kwak N, Kim SA, Choi SM, Lee J, Lee CH, Yim JJ. Longitudinal changes in health-related quality of life according to clinical course among patients with non-tuberculous mycobacterial pulmonary disease: a prospective cohort study. BMC Pulm Med. 2020 May 7;20(1):126. doi: 10.1186/s12890-020-1165-3.
- Derived from this study: PubMed 31126235Kim HJ, Lee JH, Yoon SH, Kim SA, Kim MS, Choi SM, Lee J, Lee CH, Han SK, Yim JJ. Nontuberculous mycobacterial pulmonary disease diagnosed by two methods: a prospective cohort study. BMC Infect Dis. 2019 May 24;19(1):468. doi: 10.1186/s12879-019-4078-0.
- Derived from this study: PubMed 28056937Kim SJ, Yoon SH, Choi SM, Lee J, Lee CH, Han SK, Yim JJ. Characteristics associated with progression in patients with of nontuberculous mycobacterial lung disease : a prospective cohort study. BMC Pulm Med. 2017 Jan 5;17(1):5. doi: 10.1186/s12890-016-0349-3.
- Derived from this study: PubMed 24274658Lee AR, Lee J, Choi SM, Seong MW, Kim SA, Kim M, Chae KO, Lee JS, Yim JJ. Phenotypic, immunologic, and clinical characteristics of patients with nontuberculous mycobacterial lung disease in Korea. BMC Infect Dis. 2013 Nov 25;13:558. doi: 10.1186/1471-2334-13-558.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Joon Yim, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculosis Mycobacterial Lung Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Joon Yim, MD (82-2-2072-2059, yimjj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616745, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2012.