Interstitial Lung Disease Registry Construction (ILD Registry)

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

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: monitoring changes in clinical symptoms, pulmonary function, and chest radiography

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Choi Sun Mi; Phone Number: 02-2072-4915; Email: sunmich81@gmail.com
• Study Contact Backup: Name: PARK HEEMOON; Email: coramdeo33@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Choi Sun Mi; Phone Number: 02-2072-4915; Email: sunmich81@gmail.com
    • Contact: PARK HEEMOON; Email: coramdeo33@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatient, ward

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2014
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Interstitial lung disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: ILD Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No