A Registry for Nontuberculous Mycobacterial Pulmonary Disease

NCT ID: NCT04078412

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-21

Study Completion Date

2027-11-30

Brief Summary

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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

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Conditions

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Nontuberculous Mycobacterial Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NTM pulmonary disease

Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\) not specific
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2017-0958

Identifier Type: -

Identifier Source: org_study_id

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