Taiwan Interstitial Lung Disease Multi-center Investigation and Registry
NCT ID: NCT06476470
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2024-03-10
2035-12-31
Brief Summary
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Key components of the registry include annual HRCT scans, annual CPETs, biobank blood samples, and biannual echocardiograms and pulmonary function tests.
The main questions the registry aims to answer are:
1. Differences in all-cause mortality among ILD patients of different etiologies.
2. Differences in the annual risk of acute exacerbation among ILD patients of different etiologies.
3. Effectiveness of current anti-fibrotic drugs in treating IPF and ILD of different etiologies.
4. Predictive ability of HRCT imaging features for mortality risk in ILD patients.
5. Impact of comorbidities on the mortality risk of ILD patients.
6. Predictive ability of biomarkers for disease progression and mortality.
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Detailed Description
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The investigators will conduct a prospective registry and collect clinical data of fibrotic lung disease patients from multiple centers in Taiwan. The data collected will include basic epidemiological information, comorbidities, questionnaire results, routine blood tests, biochemical tests, pulmonary function tests, echocardiograms, and cardiopulmonary exercise tests (CPET). Each hospital will follow the same protocol for data collection, establishing a real-world Taiwan Fibrotic Lung Disease Registry Database.
The details of this registry plan include:
1. Annual high-resolution computed tomography (HRCT) scans
2. Annual cardiopulmonary exercise tests (CPET)
3. Peripheral blood sampling for inclusion in a biobank
4. Additionally, echocardiograms and pulmonary function tests will be conducted every six months.
The main questions it aims to answer are:
1. Is there a difference in all-cause mortality among ILD patients of different etiologies?
2. Is there a difference in the annual risk of acute exacerbation among ILD patients of different etiologies?
3. Evaluate the real-world data on the effectiveness of current anti-fibrotic drugs in treating idiopathic pulmonary fibrosis (IPF) and ILD of different etiologies.
4. Investigate the predictive ability of high-resolution computed tomography (HRCT) imaging features for mortality risk in ILD patients.
5. Explore the impact of comorbidities on the mortality risk of ILD patients.
6. Assess the predictive ability of biomarkers for disease progression and mortality.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed as ILD by a pulmonologist, rheumatologist or radiologist
3. Various casue of ILD, including Idiopathic pulmonary fibrosis (IPF), Connective tissue disease-associated interstitial lung disease (CTD-ILD), Unclassifed ILD, drug-induced ILD, lymphangioleiomyomatosis (LAM), and sarcoidosis-associated ILD.
Exclusion Criteria
2. Failure to express informed consent in person.
18 Years
ALL
No
Sponsors
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Tri-Service General Hospital
OTHER
E-DA Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Taichung Veterans General Hospital
OTHER
Responsible Party
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Pin-Kuei Fu, MD, PhD
Principal Investigator
Principal Investigators
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Pin-Kuei Fu, MD., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Taichung Veterans General Hospital
Locations
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Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Chen YW, Lai CH, Liao YW, Liu MC, Wu YC, Hsu CY, Yu YH, Fu PK. A composite score based on cardiovascular parameters can predict the mortality risk of patients with newly diagnosed interstitial lung disease: A prospective observational study. J Cardiol. 2024 Oct;84(4):287-293. doi: 10.1016/j.jjcc.2024.03.012. Epub 2024 Apr 4.
Liao YW, Liu MC, Wu YC, Hsu CY, Huang WN, Chen YH, Fu PK. Factors influencing long-term outcomes in fibrotic interstitial lung disease (F-ILD) diagnosed through multidisciplinary discussion (MDD): a prospective cohort study. Eur J Med Res. 2024 Jan 30;29(1):91. doi: 10.1186/s40001-024-01673-2.
Liao YW, Chen YM, Liu MC, Wu YC, Hsu CY, Fu PK, Huang WN, Chen YH. Multidisciplinary-derived clinical score for accurate prediction of long-term mortality in fibrotic lung disease patients. Eur J Med Res. 2024 Jan 20;29(1):69. doi: 10.1186/s40001-024-01644-7.
Yang LY, Yang HT, Yu YH, Fu PK. Risk Model for Predicting Survival Outcomes Using Functional Exercise and Patient-Reported Outcomes in Fibrotic Interstitial Lung Disease: A Prospective Observational Study. Respirology. 2025 Jun 30. doi: 10.1111/resp.70076. Online ahead of print.
Other Identifiers
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CG24056C
Identifier Type: -
Identifier Source: org_study_id
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