Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

Study Overview
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Brief Summary
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This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.

Official Title
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Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (IPF-PRO/ILD-PRO) Registry

Conditions
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Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide informed consent Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria) Age 30 years or older, or Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype Exclusion Criteria: Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years Currently listed for lung transplantation at the time of enrollment Currently enrolled in a clinical trial at the time of enrollment in this registry

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with a new IPF diagnosis<br>Subjects with a new diagnosis of IPF established at the time of enrollment in the registry | |
| Subjects with a non-IPF ILD diagnosis<br>Subjects with a diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data on natural history of IPF & non-IPF chronic fibrosing ILD | Characterize and describe the natural history of patients with a recent confirmed diagnosis of IPF, with emphasis on demographics, co-morbidities, medications, and risks for disease progression or death. | End of Study (3 years after last patient will be enrolled) | 
| Data on current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD | Understand the current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD | End of Study (3 years after last patient will be enrolled) | 
| Data on impact of IPF & non- IPF chronic fibrosing ILD on patient quality of life. | Describe the impact of IPF & non- IPF chronic fibrosing ILD on patient quality-of-life (QOL). | End of Study (3 years after last patient will be enrolled) | 
| Blood samples for future research. | Collect longitudinal bio-samples for future research on disease presentation, progression, and subject response to clinical interventions. | End of Study (3 years after last patient will be enrolled) | 
| HRCT images for future research (for non-IPF chronic fibrosing ILD) | Collect longitudinal HRCT images for future research | End of Study (3 years after last patient will be enrolled) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data on management practices compared to existing guidelines. | Compare disease-specific management practices with existing guidelines. | End of Study (3 years after last patient will be enrolled) | 
| Data on center-specific practices on outcomes. | Determine the influence of center-specific practices on patient outcomes. | End of Study (3 years after last patient will be enrolled) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic pulmonary fibrosis, Pulmonary fibrosis, Registry, 1199.174, Interstitial Lung Disease, ILD, Interstitial Lung Disease with Progressive Phenotype, IPF