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

May 10, 2018 updated by: Jae-Joon Yim, Seoul National University Hospital

Whole Genome Sequencing of Nontuberculous Mycobacterium (NTM) Derived From Sputum Specimen of NTM Lung Disease Patients Living Together and From Their Environmental Samples

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • 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
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NTM patient group
NTM lung disease patients living together

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic similarity of NTM(Non-Tuberculous Mycobacterium)
Time Frame: Baseline
Concordance of Single Nucleotide Polymorphisms (SNP) from NTMs derived from patients and their environments
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTM_HOME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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