A Registry for Nontuberculous Mycobacterial Pulmonary Disease

• Conditions: Nontuberculous Mycobacterial Pulmonary Disease

• Registration Number: NCT04078412
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-21
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-09-01
• Study First Posted: 2019-09-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

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

Exclusion Criteria

1. not specific

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
treatment outcome based on NTM-NET consensus statement	At the end of the treatment or 12months after treatment	1. 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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of