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Status unknownNCT03532438NTM_HOMEUpdated May 22, 2018

WGS of NTM From Sputum of NTM Lung Disease Patients and From Their Environments

An observational study in Nontuberculous Mycobacterium Infection and Whole Genome Sequencing, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
6
Ages
18 Years and older
Sex
All
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Study summary

The purpose of the study is to identify the genetic closeness of NTM derived from patients living together and from their surrounding environment and to trace the temporal relationship between them.

Read the detailed description

After NTM isolation is done by using culture, from patients' sputum/bronchoscopic samples and their environmental samples, whole genome sequencing (WGS) will be conducted for all NTM isolates. Phylogenetic analysis will be performed based on single nucleotide polymorphism (SNP) on each NTM.

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Conditions studied

  • Nontuberculous Mycobacterium Infection
  • Whole Genome Sequencing
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In context

Mycobacterium Infections

136 studies on the registry are indexed under Mycobacterium Infections; 17 are open to participants now.

This study's planned enrollment of 6 is below the median of 150 across 54 observational studies indexed under Mycobacterium Infections.

Browse Mycobacterium Infections studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Among the patients visiting Seoul National University Hospital outpatient clinic, pairs of adult NTM lung disease patients who living together at the time of diagnosis were enrolled.

Inclusion criteria

  • The adult over 18 years of age
  • The patient who have respiratory symptoms consistent with NTM, such as a chronic cough, sputum, and hemoptysis, who have NTM-positive findings on CT, and who have NTM identification in two or more sputum cultures or in one or more bronchoscopic/tissue culture. (2007 ATS/IDSA guideline)
  • Pairs of patients living in the same household since diagnosis on NTM lung disease
  • Consent to a collection of environmental samples from the patient's residence.

Exclusion criteria

Exclusion Criteria:

  • If the patient does not agree or withdraw.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
6 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • NTM patient group

    NTM lung disease patients living together

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What researchers measure

Primary outcomes

  1. Genetic similarity of NTM(Non-Tuberculous Mycobacterium)

    Concordance of Single Nucleotide Polymorphisms (SNP) from NTMs derived from patients and their environments

    Time frame: Baseline

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Study locations

1 of 1 sites recruiting
  • Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
    Seoul, 110-744, Korea, Republic of
    Recruiting
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References and documents

Publications

  • Bryant JM, Grogono DM, Greaves D, Foweraker J, Roddick I, Inns T, Reacher M, Haworth CS, Curran MD, Harris SR, Peacock SJ, Parkhill J, Floto RA. Whole-genome sequencing to identify transmission of Mycobacterium abscessus between patients with cystic fibrosis: a retrospective cohort study. Lancet. 2013 May 4;381(9877):1551-60. doi: 10.1016/S0140-6736(13)60632-7. Epub 2013 Mar 29. PubMed 23541540 ↗
  • Fournier PE, Dubourg G, Raoult D. Clinical detection and characterization of bacterial pathogens in the genomics era. Genome Med. 2014 Nov 29;6(11):114. doi: 10.1186/s13073-014-0114-2. eCollection 2014. PubMed 25593594 ↗
  • Roach DJ, Burton JN, Lee C, Stackhouse B, Butler-Wu SM, Cookson BT, Shendure J, Salipante SJ. A Year of Infection in the Intensive Care Unit: Prospective Whole Genome Sequencing of Bacterial Clinical Isolates Reveals Cryptic Transmissions and Novel Microbiota. PLoS Genet. 2015 Jul 31;11(7):e1005413. doi: 10.1371/journal.pgen.1005413. eCollection 2015 Jul. Erratum In: PLoS Genet. 2017 Apr 14;13(4):e1006724. doi: 10.1371/journal.pgen.1006724. PubMed 26230489 ↗
  • Bryant JM, Grogono DM, Rodriguez-Rincon D, Everall I, Brown KP, Moreno P, Verma D, Hill E, Drijkoningen J, Gilligan P, Esther CR, Noone PG, Giddings O, Bell SC, Thomson R, Wainwright CE, Coulter C, Pandey S, Wood ME, Stockwell RE, Ramsay KA, Sherrard LJ, Kidd TJ, Jabbour N, Johnson GR, Knibbs LD, Morawska L, Sly PD, Jones A, Bilton D, Laurenson I, Ruddy M, Bourke S, Bowler IC, Chapman SJ, Clayton A, Cullen M, Daniels T, Dempsey O, Denton M, Desai M, Drew RJ, Edenborough F, Evans J, Folb J, Humphrey H, Isalska B, Jensen-Fangel S, Jonsson B, Jones AM, Katzenstein TL, Lillebaek T, MacGregor G, Mayell S, Millar M, Modha D, Nash EF, O'Brien C, O'Brien D, Ohri C, Pao CS, Peckham D, Perrin F, Perry A, Pressler T, Prtak L, Qvist T, Robb A, Rodgers H, Schaffer K, Shafi N, van Ingen J, Walshaw M, Watson D, West N, Whitehouse J, Haworth CS, Harris SR, Ordway D, Parkhill J, Floto RA. Emergence and spread of a human-transmissible multidrug-resistant nontuberculous mycobacterium. Science. 2016 Nov 11;354(6313):751-757. doi: 10.1126/science.aaf8156. PubMed 27846606 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03532438
Lead sponsor
Seoul National University Hospital
Responsible party
Jae-Joon Yim (Professor, Seoul National University Hospital) — Principal investigator
First posted
May 22, 2018
Start date
May 2018 (estimated)
Primary completion
May 2019 (estimated)
Completion
May 2019 (estimated)
Last update
May 22, 2018

Study contacts

Jae-June Yim, MD
Contact
yimjj@snu.ac.kr
+82-2-2072-2059
Jae-June Yim, MD
principal investigator · Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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