Clinical trial NCT03238989: Interstitial Lung Disease Registry Construction
Official title: Interstitial Lung Disease Registry Construction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Keywords: Interstitial lung disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient, ward

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: St George's Respiratory Questionnaire(SGRQ)
timeFrame: at baseline, every 1 year through study completion for 10 years
measure: modified Medical Research Council (mMRC) dyspnea scale
timeFrame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
measure: Borg dyspnea scale
timeFrame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
measure: Hospital anxiety and depression score(HADS)
timeFrame: at baseline, every 1 year through study completion for 10 years
measure: chest X-ray
timeFrame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
measure: Chest CT
timeFrame: at baseline, every 1 year through study completion for 10 years
measure: Paranasal sinus X-ray(PNS series)
timeFrame: at baseline
measure: Electrocardiogram(ECG)
timeFrame: at baseline
measure: Pulmonary function test with bronchodilator response test(PFT+BDR)
timeFrame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
measure: Diffusing capacity of the lungs for carbon monoxide(DLCO)
timeFrame: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
measure: total lung capacity(TLC)
timeFrame: at baseline
measure: Bronchoscopic alveolar lavage(BAL)
timeFrame: at baseline
measure: Video-assisted thoracoscopic surgery(VATS) lung biopsy
timeFrame: at baseline
measure: echocardiography
timeFrame: at baseline
measure: arterial blood gas analysis(ABGA)
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: