Interstitial Lung Disease Registry Construction

Overview

The purpose of this study is investigating the clinical course, treatment course, and prognosis of patients with interstitial lung disease.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Detailed Description

Interstitial lung disease refers to pulmonary disease that occurs in the interstitium of the lung.

It can be broadly classified into lung disease secondary to the cause of systemic disease or drug, and lung disease whose cause is unknown, and the latter is known as idiopathic interstitial pneumonia.

Idiopathic interstitial pneumonia is a lung disease showing various aspects of inflammatory response and fibrosis reaction, and the cause of the onset is not accurately known yet, also there is no effective treatment.

Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis, progresses very slowly, but sometimes acute exacerbation without any obvious cause leads to death, rapidly.

Therefore, it is important to collect data prospectively for changes in clinical features, pulmonary function, imaging findings, and quality of life of these patients.

A prospective study of idiopathic interstitial pneumonia will provide important information on the clinical characteristics and admission history of patients with idiopathic interstitial pneumonia, and the idiopathic interstitial pneumonia registry system will serve as the basis for further prospective observational studies.

The aim of this study is to establish the registry of patients with interstitial lung disease and to prospectively review the clinical features and progression of the patients.

Interventions

  • Other: monitoring changes in clinical symptoms, pulmonary function, and chest radiography
    • For patients with interstitial lung disease, the investigators regularly monitor changes in clinical symptoms, pulmonary function, and chest radiography after basic questionnaire on symptoms, lifestyle, depression, and quality of life.

Clinical Trial Outcome Measures

Primary Measures

  • St George’s Respiratory Questionnaire(SGRQ)
    • Time Frame: at baseline, every 1 year through study completion for 10 years
    • monitoring changes in clinical symptoms
  • modified Medical Research Council (mMRC) dyspnea scale
    • Time Frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
    • monitoring changes in clinical symptoms
  • Borg dyspnea scale
    • Time Frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
    • monitoring changes in clinical symptoms
  • Hospital anxiety and depression score(HADS)
    • Time Frame: at baseline, every 1 year through study completion for 10 years
    • monitoring changes in clinical symptoms
  • chest X-ray
    • Time Frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
    • monitoring changes in chest radiography
  • Chest CT
    • Time Frame: at baseline, every 1 year through study completion for 10 years
    • monitoring changes in chest radiography
  • Paranasal sinus X-ray(PNS series)
    • Time Frame: at baseline
    • baseline PNS X-ray
  • Electrocardiogram(ECG)
    • Time Frame: at baseline
    • baseline ECG
  • Pulmonary function test with bronchodilator response test(PFT+BDR)
    • Time Frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
    • monitoring changes in lung function
  • Diffusing capacity of the lungs for carbon monoxide(DLCO)
    • Time Frame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
    • monitoring changes in lung function
  • total lung capacity(TLC)
    • Time Frame: at baseline
    • monitoring changes in lung function
  • Bronchoscopic alveolar lavage(BAL)
    • Time Frame: at baseline
    • for diagnostic purposes if necessary
  • Video-assisted thoracoscopic surgery(VATS) lung biopsy
    • Time Frame: at baseline
    • for diagnostic purposes if necessary
  • echocardiography
    • Time Frame: at baseline
    • additionally tested at acute exacerbation
  • arterial blood gas analysis(ABGA)
    • Time Frame: at baseline
    • additionally tested at acute exacerbation

Participating in This Clinical Trial

Inclusion Criteria

  • Patients older than 20 years diagnosed with interstitial lung disease
  • Diagnostic criteria for interstitial lung disease. If one of the following is met:

1. clinical suspicion of idiopathic pulmonary fibrosis (IPF); Characteristic chest CT findings with honeycomb cysts and fibrosis and reasonable clinical signs

2. suspected interstitial pneumonia, or confirmed by biopsy with no evidence of infection : IPF, Non-specific interstitial pneumonia(NSIP), Cryptogenic organizing pneumonia(COP), unclassified fibrosis

3. interstitial lung disease suspects with underlying rheumatic disease

Exclusion Criteria

  • No specific criteria

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sun Mi Choi, Assistant professor – Seoul National University Hospital
  • Overall Contact(s)
    • Choi Sun Mi, 02-2072-4915, sunmich81@gmail.com

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