A Registry for Nontuberculous Mycobacterial Pulmonary Disease

Overview

Background:

NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.

objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.

Methods:

1. informed consents

2. register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria

3. follow up 6 months to 1year based on the clinical situation

Analysis:

1. treatment outcome based on NTM-NET consensus statement

2. exploration of biomarker for progression and monitoring of treatment response

Full Title of Study: “A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2027

Arms, Groups and Cohorts

  • NTM pulmonary disease
    • Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline

Clinical Trial Outcome Measures

Primary Measures

  • treatment outcome based on NTM-NET consensus statement
    • Time Frame: At the end of the treatment or 12months after treatment
    • For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results For patients who don’t need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.

Secondary Measures

  • biomarker for disease progression: RNA sequence analysis
    • Time Frame: at the beginning of the treatment
    • exploration for various biomarkers with RNA sequence analysis
  • biomarker for disease progression: metabolomic analysis
    • Time Frame: at the beginning of the treatment
    • exploration for various biomarkers with metabolomic analysis
  • biomarker for disease progression: RNA sequence analysis
    • Time Frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
    • exploration for various biomarkers with RNA sequence analysis
  • biomarker for disease progression: metabolomic analysis
    • Time Frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
    • exploration for various biomarkers with metabolomic analysis
  • biomarker for monitoring of treatment response: RNA sequence analysis
    • Time Frame: at the beginning of the treatment
    • exploration for various biomarkers with RNA sequence analysis
  • biomarker for monitoring of treatment response: metabolomic analysis
    • Time Frame: at the beginning of the treatment
    • exploration for various biomarkers with metabolomic analysis
  • biomarker for monitoring of treatment response: RNA sequence analysis
    • Time Frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
    • exploration for various biomarkers with RNA sequence analysis
  • biomarker for monitoring of treatment response: metabolomic analysis
    • Time Frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
    • exploration for various biomarkers with metabolomic analysis

Participating in This Clinical Trial

Inclusion Criteria

1. age 20 or more than 20 years

2. diagnosed by ATS criteria for NTM pulmonary disease

Exclusion Criteria

1) not specific

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor

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