Interstitial Lung Disease Registry Construction

Interstitial Lung Disease Clinical Trial

— ILD Registry  

Official title:

Interstitial Lung Disease Registry Construction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238989
• Other study ID #: ILD Registry
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2017
• Last updated: August 1, 2017
• Start date: January 5, 2014
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2017
• Source: Seoul National University Hospital
• Contact: Choi Sun Mi
• Phone: 02-2072-4915
• Email: sunmich81[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	St George's Respiratory Questionnaire(SGRQ)	monitoring changes in clinical symptoms	at baseline, every 1 year through study completion for 10 years
Primary	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
Primary	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
Primary	Hospital anxiety and depression score(HADS)	monitoring changes in clinical symptoms	at baseline, every 1 year through study completion for 10 years
Primary	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
Primary	Chest CT	monitoring changes in chest radiography	at baseline, every 1 year through study completion for 10 years
Primary	Paranasal sinus X-ray(PNS series)	baseline PNS X-ray	at baseline
Primary	Electrocardiogram(ECG)	baseline ECG	at baseline
Primary	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
Primary	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
Primary	total lung capacity(TLC)	monitoring changes in lung function	at baseline
Primary	Bronchoscopic alveolar lavage(BAL)	for diagnostic purposes if necessary	at baseline
Primary	Video-assisted thoracoscopic surgery(VATS) lung biopsy	for diagnostic purposes if necessary	at baseline
Primary	echocardiography	additionally tested at acute exacerbation	at baseline
Primary	arterial blood gas analysis(ABGA)	additionally tested at acute exacerbation	at baseline