Taiwan Interstitial Lung Disease Multi-center Investigation and Registry

Last updated: June 24, 2024
Sponsor: Taichung Veterans General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Arterial Hypertension

Respiratory Failure

Lung Injury

Treatment

N/A

Clinical Study ID

NCT06476470
CG24056C
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

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), Connectivetissue disease-associated interstitial lung disease (CTD-ILD), Unclassifed ILD,drug-induced ILD, lymphangioleiomyomatosis (LAM), and sarcoidosis-associated ILD.

Exclusion

Exclusion Criteria:

  1. Under 18 years of age.

  2. Failure to express informed consent in person.

Study Design

Total Participants: 10000
Study Start date:
March 10, 2024
Estimated Completion Date:
December 31, 2035

Study 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:

  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.

Connect with a study center

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

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