Interstitial Lung Disease Registry Construction

Interstitial Lung Disease Registry Construction

Sponsors

Lead sponsor: Seoul National University Hospital

Source Seoul National University Hospital
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.

Overall Status Recruiting
Start Date January 5, 2014
Completion Date December 31, 2023
Primary Completion Date December 31, 2023
Study Type Observational
Primary Outcome
Measure Time Frame
St George's Respiratory Questionnaire(SGRQ) at baseline, every 1 year through study completion for 10 years
modified Medical Research Council (mMRC) dyspnea scale at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
Borg dyspnea scale at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
Hospital anxiety and depression score(HADS) at baseline, every 1 year through study completion for 10 years
chest X-ray at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
Chest CT at baseline, every 1 year through study completion for 10 years
Paranasal sinus X-ray(PNS series) at baseline
Electrocardiogram(ECG) at baseline
Pulmonary function test with bronchodilator response test(PFT+BDR) at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
Diffusing capacity of the lungs for carbon monoxide(DLCO) at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
total lung capacity(TLC) at baseline
Bronchoscopic alveolar lavage(BAL) at baseline
Video-assisted thoracoscopic surgery(VATS) lung biopsy at baseline
echocardiography at baseline
arterial blood gas analysis(ABGA) at baseline
Enrollment 300
Condition
Intervention

Intervention type: Other

Intervention name: monitoring changes in clinical symptoms, pulmonary function, and chest radiography

Description: 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.

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Overall Contact

Last name: Choi Sun Mi

Phone: 02-2072-4915

Email: [email protected]

Location
facility status contact contact_backup Seoul National University Hospital Choi Sun Mi 02-2072-4915 [email protected]
Location Countries

Korea, Republic of

Verification Date

August 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Seoul National University Hospital

Investigator full name: Sun Mi Choi

Investigator title: Assistant professor

Keywords
Has Expanded Access No
Condition Browse
Acronym ILD Registry
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov