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NCT Number: NCT06476470

Taiwan Interstitial Lung Disease Multi-center Investigation and Registry

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.

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Key information

Conditions

Interstitial Lung Disease Behavior Comorbidities and Coexisting Conditions Function Impaired Respiratory Health Behavior Hypertension, Pulmonary Lung Diseases Lung Diseases, Interstitial Pulmonary Arterial Hypertension Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Treatment Adherence Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location status: Recruiting

Location contact

Pin-Kuei Fu, MD, PhD

CONTACT

[email protected]

886-4-23592525 ext. 3213

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 10 years

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

  2. 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

Secondary outcomes

  1. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pin-Kuei Fu, MD., Ph.D

CONTACT

[email protected]

04-23592525 ext. 6536

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Collaborators

  • Chang Gung Memorial Hospital
  • E-DA Hospital
  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

A Prospective Multi-center Registry for Fibrotic Lung Disease, Focusing on Clinical Phenotype, Physical Parameters, Image Analysis, and Precision Medicine in Taiwan

Acronym: TAILI

Important dates

Study start
2024
Primary completion
2033
Study completion
2035
First posted
Jun 26, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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