Clinical trial NCT03532438: WGS of NTM From Sputum of NTM Lung Disease Patients and From Their Environments
Official title: Whole Genome Sequencing of Nontuberculous Mycobacterium (NTM) Derived From Sputum Specimen of NTM Lung Disease Patients Living Together and From Their Environmental Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nontuberculous Mycobacterium Infection
Whole Genome Sequencing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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:

* If the patient does not agree or withdraw.

Primary outcomes:
measure: Genetic similarity of NTM(Non-Tuberculous Mycobacterium)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
Study officials:
affiliation: Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
name: Jae-June Yim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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