A Registry for Nontuberculous Mycobacterial Pulmonary Disease

Study Overview
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Brief Summary
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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: informed consents register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria follow up 6 months to 1year based on the clinical situation Analysis: treatment outcome based on NTM-NET consensus statement exploration of biomarker for progression and monitoring of treatment response

Official Title
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A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease

Conditions
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Nontuberculous Mycobacterial Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20 or more than 20 years diagnosed by ATS criteria for NTM pulmonary disease Exclusion Criteria: 1) not specific

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NTM pulmonary disease<br>Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment outcome based on NTM-NET consensus statement | 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. | At the end of the treatment or 12months after treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nontuberculous mycobacteria, pulmonary, cohort