Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04078412
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2019-11-18
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registry for Nontuberculous Mycobacterial Pulmonary Disease
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: