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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03532438
Collaborator
(none)
6
Enrollment
1
Location
12
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    6 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    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
    Anticipated Study Start Date :
    May 1, 2018
    Anticipated Primary Completion Date :
    May 1, 2019
    Anticipated Study Completion Date :
    May 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    NTM patient group

    NTM lung disease patients living together

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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 Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jae-June Yim, MD, 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jae-Joon Yim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03532438
    Other Study ID Numbers:
    • NTM_HOME
    First Posted:
    May 22, 2018
    Last Update Posted:
    May 22, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycobacterium Infections
    Mycobacterium Infections, Nontuberculous
    Lung Diseases

    Study Results

    No Results Posted as of May 22, 2018