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A Registry for Nontuberculous Mycobacterial Pulmonary Disease

A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04078412
Enrollment
114
Registered
2019-09-06
Start date
2017-11-21
Completion date
2027-11-30
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Keywords

Nontuberculous mycobacteria, pulmonary, cohort

Brief summary

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

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age 20 or more than 20 years 2. diagnosed by ATS criteria for NTM pulmonary disease

Exclusion criteria

1\) not specific

Design outcomes

Primary

MeasureTime frameDescription
treatment outcome based on NTM-NET consensus statementAt the end of the treatment or 12months after treatment1. 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 2. For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.

Secondary

MeasureTime frameDescription
biomarker for disease progression: RNA sequence analysisat the beginning of the treatmentexploration for various biomarkers with RNA sequence analysis
biomarker for disease progression: metabolomic analysisat the beginning of the treatmentexploration for various biomarkers with metabolomic analysis
biomarker for monitoring of treatment response: RNA sequence analysisat the beginning of the treatmentexploration for various biomarkers with RNA sequence analysis
biomarker for monitoring of treatment response: metabolomic analysisat the beginning of the treatmentexploration for various biomarkers with metabolomic analysis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026