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Genome-Wide Association Study in Patients With Nontuberculous Mycobacterial Lung Disease

This study is currently recruiting participants.
Verified November 2017 by Jae-Joon Yim, Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832843
First Posted: July 14, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jae-Joon Yim, Seoul National University Hospital
  Purpose
The aim of this study was to elucidate genetic susceptibility of patients with nontuberculous mycobacterial lung disease using genome-wide association study.

Condition
Mycobacterium Infections, Nontuberculous

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Elucidation of Genetic Susceptibility of Patients With Nontuberculous Mycobacterial Lung Disease Using Genome-Wide Association Study

Resource links provided by NLM:


Further study details as provided by Jae-Joon Yim, Seoul National University Hospital:

Primary Outcome Measures:
  • Finding of single nucleotide polymorphisms (SNPs) associated with the risk of NTM lung disease compared with controls [ Time Frame: Baseline ]
    To identify SNPs related to NTM lung disease using logistic regression after controlling for confounders (GWAS statistical significance threshold, P < 5.00*E-08)


Secondary Outcome Measures:
  • Finding of SNPs associated with the risk of severe NTM lung disease compared with controls [ Time Frame: Baseline ]
    To identify SNPs related to severe NTM lung disease compared with controls using logistic regression after controlling for confounders (GWAS statistical significance threshold, P < 5.00*E-08)

  • Finding of SNPs associated with the risk of severe NTM lung disease compared with mild NTM lung disease [ Time Frame: Baseline ]
    To identify SNPs related to severe NTM lung disease compared with mild NTM lung disease using logistic regression after controlling for confounders (GWAS statistical significance threshold, P < 5.00*E-08)

  • Finding of SNPs associated with the risk of Mycobacterium avium complex lung disease versus M. abscessus lung disease versus controls [ Time Frame: Baseline ]
    To identify SNPs related to Mycobacterium avium complex lung disease versus M. abscessus lung disease versus controls using multinomial logistic regression after controlling for confounders (GWAS statistical significance threshold, P < 5.00*E-08)


Biospecimen Retention:   Samples With DNA
Extraction of DNA will be conducted from serum of patients with NTM lung disease. For controls, preexisting dataset of GWAS will be used.

Estimated Enrollment: 1200
Study Start Date: July 11, 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
NTM lung disease
Patients with NTM lung disease satisfying American Thoracic Society guidelines
Healthy control
The age-, sex-matched control subjects without pulmonary diseases

Detailed Description:
Nontuberculous mycobacteria (NTM) are ubiquitous environmental organisms. NTM lung disease is increasing, however, genetic susceptibility of patients with the disease have not been identified. To elucidate the genetic susceptibility of NTM lung disease, the investigators perform a genome-wide association study (GWAS) including patients with NTM lung disease and healthy controls (case : control = 1 : 3). The age-, sex-matched control group will be recruited from the Korean Healthy Twin Study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with NTM lung diseases and healthy control
Criteria

Inclusion Criteria:

  • Case: Patients with NTM lung disease satisfying diagnostic criteria suggested by American Thoracic Society
  • Control: Healthy subjects enrolled in the Korean Healthy Twin Study

Exclusion Criteria:

  • Case: none
  • Control: 1) Subjects who have respiratory symptoms including cough and sputum 2) Subjects who have abnormalities on chest radiography
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832843


Contacts
Contact: Jae-Joon Yim, MD, PhD 82-2-2072-2059 yimjj@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jae-Joon Yim, MD, PhD    +82-2-2072-2059    yimjj@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jae-Joon Yim, MD, PhD Seoul National University Hospital
  More Information

Publications:

Responsible Party: Jae-Joon Yim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02832843     History of Changes
Other Study ID Numbers: H-1605-111-763
First Submitted: July 3, 2016
First Posted: July 14, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections