Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476470
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-22
Brief Title:
Taiwan Interstitial Lung Disease Multi-center Investigation and Registry
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
A Prospective Multi-center Registry for Fibrotic Lung Disease Focusing on Clinical Phenotype Physical Parameters Image Analysis and Precision Medicine in Taiwan
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAILI
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 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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None