Taiwan Interstitial Lung Disease Multi-center Investigation and Registry

NCT06476470 | Recruiting

• 1 other identifier: CG24056C
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Differences in all-cause mortality among ILD patients of different etiologies.
2. 2.Differences in the annual risk of acute exacerbation among ILD patients of different etiologies.
3. 3.Effectiveness of current anti-fibrotic drugs in treating IPF and ILD of different etiologies.
4. 4.Predictive ability of HRCT imaging features for mortality risk in ILD patients.
5. 5.Impact of comorbidities on the mortality risk of ILD patients.
6. 6.Predictive ability of biomarkers for disease progression and mortality.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  All-cause mortality of the enrolled patients from enrollment to the death event

  10 years

• Annual rate of acute exacerbation

  The event of visiting the emergency room or being hospitalized will be recorded

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Annual rate of progressive pulmonary fibrosis

  From date of enrolled until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enroll patients with various causes of fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF), connective tissue disease-associated interstitial lung disease (CTD-ILD), unclassified ILD, pneumoconiosis, drug-induced ILD, lymphangioleiomyomatosis (LAM), and sarcoidosis-associated ILD. All included ILD cases must be diagnosed through a multidisciplinary discussion at each hospital. The specialists involved should include at least a pulmonologist, rheumatologist, and radiologist. If a patient has a pathology diagnosis, the pathologist should also provide their recommendations and expert opinions.

You may qualify if:

• Aged over 18 years old.
• Diagnosed as ILD by a pulmonologist, rheumatologist or radiologist
• 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.

You may not qualify if:

• Under 18 years of age.
• Failure to express informed consent in person.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Tri-Service General Hospital: collaborator
• E-DA Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 38582493 RESULT

• 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.

  PMID: 38291459 RESULT

• 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.

  PMID: 38245785 RESULT

• Tsai YL, Chang KM, Chin CS, Hsu CY, Yu YH, Cheng YY, Fu PK. Prognostic Value of a Cardiopulmonary Exercise Testing-Derived Summed Score in Idiopathic Pulmonary Fibrosis and Connective Tissue Disease-Associated Interstitial Lung Disease: A Prospective Cohort Study. Respirology. 2025 Dec 22. doi: 10.1002/resp.70193. Online ahead of print.

  PMID: 41431164 DERIVED

• 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 Nov;30(11):1077-1086. doi: 10.1111/resp.70076. Epub 2025 Jun 30.

  PMID: 40589147 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Precision medicine involves tailoring medical solutions to individual patients, aiming to precisely predict, prevent, diagnose, and treat diseases. If this goal is not achieved, it is necessary to collect patient-reported symptoms, physician treatment records, and results of routine medical examinations, along with biomedical test data such as genetic testing. By comparing and analyzing this data with existing precision medicine knowledge databases, the most suitable treatment methods, medication adjustments, and health management strategies can be identified.

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Arterial Hypertension; Treatment Adherence and Compliance; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension, Pulmonary; Health Behavior; Behavior; Respiration Disorders

Study Officials

• Pin-Kuei Fu, MD., Ph.D

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin-Kuei Fu, MD., Ph.D

CONTACT

04-23592525; yetquen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 26, 2024
• Study Start: March 10, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

TW (1)