Clinical trial NCT04078412: A Registry for Nontuberculous Mycobacterial Pulmonary Disease
Official title: A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nontuberculous Mycobacterial Pulmonary Disease
Keywords: Nontuberculous mycobacteria
pulmonary
cohort
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpaient clinic and hospitalzed patients in tertiary referral hospital

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1) not specific

Primary outcomes:
measure: treatment outcome based on NTM-NET consensus statement
timeFrame: At the end of the treatment or 12months after treatment
Secondary outcomes:
measure: biomarker for disease progression: RNA sequence analysis
timeFrame: at the beginning of the treatment
measure: biomarker for disease progression: metabolomic analysis
timeFrame: at the beginning of the treatment
measure: biomarker for disease progression: RNA sequence analysis
timeFrame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
measure: biomarker for disease progression: metabolomic analysis
timeFrame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
measure: biomarker for monitoring of treatment response: RNA sequence analysis
timeFrame: at the beginning of the treatment
measure: biomarker for monitoring of treatment response: metabolomic analysis
timeFrame: at the beginning of the treatment
measure: biomarker for monitoring of treatment response: RNA sequence analysis
timeFrame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
measure: biomarker for monitoring of treatment response: metabolomic analysis
timeFrame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Study officials:
References: