Taiwan Interstitial Lung Disease Multi-center Investigation and Registry

NCT ID: NCT06476470

Last Updated: 2024-06-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-10

Study Completion Date

2035-12-31

Brief Summary

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The Taiwan Interstitial Lung Disease (ILD) Multi-center Investigation and Registry aims to evaluate the long-term outcomes of patients with fibrotic interstitial lung disease. This prospective observational registry will collect comprehensive clinical data from multiple centers, including epidemiological information, comorbidities, questionnaire results, routine blood tests, biochemical tests, pulmonary function tests, echocardiograms, and cardiopulmonary exercise tests (CPET), all following a standardized protocol.

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.

Detailed Description

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The goal of this prospective observational registry is to evaluate the long-term outcomes of patients diagnosed with fibrotic interstitial lung disease in Taiwan.

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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Interstitial Lung Disease Comorbidities and Coexisting Conditions Pulmonary Arterial Hypertension Treatment Adherence Function Impaired Respiratory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Aged over 18 years old.
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

1. Under 18 years of age.
2. Failure to express informed consent in person.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role collaborator

E-DA Hospital

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pin-Kuei Fu, MD, PhD

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pin-Kuei Fu, MD., Ph.D

Role: CONTACT

04-23592525 ext. 6536

Facility Contacts

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Pin-Kuei Fu, MD, PhD

Role: primary

886-4-23592525 ext. 3213

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.

Reference Type RESULT
PMID: 38582493 (View on PubMed)

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.

Reference Type RESULT
PMID: 38291459 (View on PubMed)

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.

Reference Type RESULT
PMID: 38245785 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40589147 (View on PubMed)

Other Identifiers

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CG24056C

Identifier Type: -

Identifier Source: org_study_id

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