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NCT Number: NCT04078412

A Registry for Nontuberculous Mycobacterial Pulmonary Disease

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

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Key information

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 20 or more than 20 years
  • diagnosed by ATS criteria for NTM pulmonary disease

Exclusion criteria

  • not specific

Treatment and study plan

Primary outcomes

  1. treatment outcome based on NTM-NET consensus statement

    Time frame: At the end of the treatment or 12months after treatment

    • 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.

Secondary outcomes

  1. biomarker for disease progression: RNA sequence analysis

    Time frame: at the beginning of the treatment

    exploration for various biomarkers with RNA sequence analysis

  2. biomarker for disease progression: metabolomic analysis

    Time frame: at the beginning of the treatment

    exploration for various biomarkers with metabolomic analysis

  3. biomarker for disease progression: RNA sequence analysis

    Time frame: 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

  4. biomarker for disease progression: metabolomic analysis

    Time frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)

    exploration for various biomarkers with metabolomic analysis

  5. biomarker for monitoring of treatment response: RNA sequence analysis

    Time frame: at the beginning of the treatment

    exploration for various biomarkers with RNA sequence analysis

  6. biomarker for monitoring of treatment response: metabolomic analysis

    Time frame: at the beginning of the treatment

    exploration for various biomarkers with metabolomic analysis

  7. biomarker for monitoring of treatment response: RNA sequence analysis

    Time frame: 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

  8. biomarker for monitoring of treatment response: metabolomic analysis

    Time frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)

    exploration for various biomarkers with metabolomic analysis

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Sep 6, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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