Interstitial Lung DiseaseTAILINCT06476470
Taiwan Interstitial Lung Disease Multi-center Investigation and Registry
An observational study of Interstitial Lung Disease and Comorbidities and Coexisting Conditions, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Comorbidities and Coexisting Conditions, Pulmonary Arterial Hypertension
- How many people
- 10,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2024to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Under 18 years of age.
- Failure to express informed consent in person.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Pin-Kuei Fu, MD, PhD, 886-4-23592525 ext. 3213, yetquen@gmail.com
About this study
Official title: A Prospective Multi-center Registry for Fibrotic Lung Disease, Focusing on Clinical Phenotype, Physical Parameters, Image Analysis, and Precision Medicine in Taiwan
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.
Read more
The main questions the registry aims to answer are:
- Differences in all-cause mortality among ILD patients of different etiologies.
- Differences in the annual risk of acute exacerbation among ILD patients of different etiologies.
- Effectiveness of current anti-fibrotic drugs in treating IPF and ILD of different etiologies.
- Predictive ability of HRCT imaging features for mortality risk in ILD patients.
- Impact of comorbidities on the mortality risk of ILD patients.
- Predictive ability of biomarkers for disease progression and mortality.
Read the detailed description
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:
- Annual high-resolution computed tomography (HRCT) scans
- Annual cardiopulmonary exercise tests (CPET)
- Peripheral blood sampling for inclusion in a biobank
- Additionally, echocardiograms and pulmonary function tests will be conducted every six months.
The main questions it aims to answer are:
- Is there a difference in all-cause mortality among ILD patients of different etiologies?
- Is there a difference in the annual risk of acute exacerbation among ILD patients of different etiologies?
- Evaluate the real-world data on the effectiveness of current anti-fibrotic drugs in treating idiopathic pulmonary fibrosis (IPF) and ILD of different etiologies.
- Investigate the predictive ability of high-resolution computed tomography (HRCT) imaging features for mortality risk in ILD patients.
- Explore the impact of comorbidities on the mortality risk of ILD patients.
- Assess the 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
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Arterial Hypertension, Treatment Adherence and Compliance, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality of the enrolled patients from enrollment to the death event
Measured: 10 years
Annual rate of acute exacerbation
The event of visiting the emergency room or being hospitalized will be recorded
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Annual rate of progressive pulmonary fibrosis
By the definition according to ATS 2022 guideline, including symptoms worsening, Lung function declined (FVC decreased more than 5 % or DLCO decreased more than 10% within one year) and the image pattern showed progression on HRCT scan
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start10 Mar 2024
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), E-DA Hospital, Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital
- Investigators
- Pin-Kuei Fu, MD., Ph.D, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476470
- Sponsor's protocol ID
- CG24056C
- Acronym
- TAILI
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38582493Liao 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.
PubMed 38291459Liao 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.
PubMed 38245785Tsai 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. 2026 May;31(5):498-508. doi: 10.1002/resp.70193. Epub 2025 Dec 22.
PubMed 41431164Yang 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.
PubMed 40589147
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Registry for Fibrotic Lung Disease, Focusing on Clinical Phenotype, Physical Parameters, Image Analysis, and Precision Medicine in Taiwan
- ClinicalTrials.gov ID
- NCT06476470
- Acronym / sponsor ID
- TAILI / CG24056C
- Conditions
- Interstitial Lung Disease, Comorbidities and Coexisting Conditions, Pulmonary Arterial Hypertension, Treatment Adherence, Function Impaired Respiratory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), E-DA Hospital, Chang Gung Memorial Hospital
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Differences in all-cause mortality among ILD patients of different etiologies.
- Differences in the annual risk of acute exacerbation among ILD patients of different etiologies.
- Effectiveness of current anti-fibrotic drugs in treating IPF and ILD of different etiologies.
- Predictive ability of HRCT imaging features for mortality risk in ILD patients.
- Impact of comorbidities on the mortality risk of ILD patients.
- Predictive ability of biomarkers for disease progression and mortality.
Detailed description
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:
- Annual high-resolution computed tomography (HRCT) scans
- Annual cardiopulmonary exercise tests (CPET)
- Peripheral blood sampling for inclusion in a biobank
- Additionally, echocardiograms and pulmonary function tests will be conducted every six months.
The main questions it aims to answer are:
- Is there a difference in all-cause mortality among ILD patients of different etiologies?
- Is there a difference in the annual risk of acute exacerbation among ILD patients of different etiologies?
- Evaluate the real-world data on the effectiveness of current anti-fibrotic drugs in treating idiopathic pulmonary fibrosis (IPF) and ILD of different etiologies.
- Investigate the predictive ability of high-resolution computed tomography (HRCT) imaging features for mortality risk in ILD patients.
- Explore the impact of comorbidities on the mortality risk of ILD patients.
- Assess the predictive ability of biomarkers for disease progression and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Under 18 years of age.
- Failure to express informed consent in person.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 10 years
All-cause mortality of the enrolled patients from enrollment to the death event
Annual rate of acute exacerbation
Time frame: through study completion, an average of 1 year
The event of visiting the emergency room or being hospitalized will be recorded
1 secondary outcome
Annual rate of progressive pulmonary fibrosis
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Results publication: PubMed 38582493Chen 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.
- Results publication: PubMed 38291459Liao 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.
- Results publication: PubMed 38245785Liao 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.
- Derived from this study: PubMed 41431164Tsai 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. 2026 May;31(5):498-508. doi: 10.1002/resp.70193. Epub 2025 Dec 22.
- Derived from this study: PubMed 40589147Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pin-Kuei Fu, MD., Ph.D principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Comorbidities and Coexisting Conditions, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pin-Kuei Fu, MD., Ph.D (04-23592525 ext. 6536, yetquen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06476470, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.