Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry (IPF-ILD PRO)
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|ClinicalTrials.gov Identifier: NCT01915511|
Recruitment Status : Active, not recruiting
First Posted : August 5, 2013
Last Update Posted : November 6, 2018
|Condition or disease|
|Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||December 2024|
Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry
Subjects with a non-IPF ILD diagnosis
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
- Data on natural history of IPF & non-IPF ILD [ Time Frame: End of Study (3 years after last patient will be enrolled) ]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.
- Data on current practice patterns for diagnosis of IPF & non-IPF ILD [ Time Frame: End of Study (3 years after last patient will be enrolled) ]Understand the current practice patterns for diagnosis of IPF &non-IPF ILD
- Data on impact of IPF & non-IPF ILD on patient quality of life. [ Time Frame: End of Study (3 years after last patient will be enrolled) ]Describe the impact of IPF on patient quality-of-life (QOL).
- Blood samples for future research. [ Time Frame: End of Study (3 years after last patient will be enrolled) ]Collect longitudinal bio-samples for future research on disease presentation, progression, and subject response to clinical interventions.
- HRCT images for future research (for non-IPF ILD patients) [ Time Frame: End of Study (3 years after last patient will be enrolled) ]Collect longitudinal HRCT images for future research
- Data on management practices compared to existing guidelines. [ Time Frame: End of Study (3 years after last patient will be enrolled) ]Compare disease-specific management practices with existing guidelines.
- Data on center-specific practices on outcomes. [ Time Frame: End of Study (3 years after last patient will be enrolled) ]Determine the influence of center-specific practices on patient outcomes.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915511
Show 45 Study Locations
|Principal Investigator:||Scott Palmer, MD||Duke Clinical Research Institute, Duke University|