Nontuberculous Mycobacterial Pulmonary Disease Clinical Trial
Official title:
A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease
| Verified date | November 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Enrolling by invitation |
| Enrollment | 114 |
| Est. completion date | November 2027 |
| Est. primary completion date | November 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: 1. age 20 or more than 20 years 2. diagnosed by ATS criteria for NTM pulmonary disease Exclusion Criteria: 1) not specific |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | biomarker for disease progression: RNA sequence analysis | exploration for various biomarkers with RNA sequence analysis | at the beginning of the treatment | |
| Secondary | biomarker for disease progression: metabolomic analysis | exploration for various biomarkers with metabolomic analysis | at the beginning of the treatment | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | biomarker for monitoring of treatment response: RNA sequence analysis | exploration for various biomarkers with RNA sequence analysis | at the beginning of the treatment | |
| Secondary | biomarker for monitoring of treatment response: metabolomic analysis | exploration for various biomarkers with metabolomic analysis | at the beginning of the treatment | |
| Secondary | 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) | |
| Secondary | 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) |