Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease Clinical Trial
— IPF/ILD-PROOfficial title:
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (IPF-PRO/ILD-PRO) Registry
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.
| Status | Recruiting |
| Enrollment | 2000 |
| Est. completion date | January 2028 |
| Est. primary completion date | January 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Ponce Research Institute | Ponce | |
| United States | Albany Medical Center | Albany | New York |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | Piedmont Healthcare | Austell | Georgia |
| United States | University from Virginia | Baltimore | Maryland |
| United States | University of Alabama - Birmingham | Birmingham | Alabama |
| United States | Lahey Clinic | Burlington | Massachusetts |
| United States | Vermont Lung Center | Burlington | Vermont |
| United States | UNC Chapel Hill | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of Chicago | Chicago | Illinois |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Baylor University Medical Center at Dallas | Dallas | Texas |
| United States | University of Texas Southwestern | Dallas | Texas |
| United States | Duke University | Durham | North Carolina |
| United States | Northwestern University | Evanston | Illinois |
| United States | Pulmonix LLC | Greensboro | North Carolina |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Houston Methodist Lung Center | Houston | Texas |
| United States | University of Kansas | Kansas City | Kansas |
| United States | University of California - Los Angeles | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Lynchburg Pulmonary Associates | Lynchburg | Virginia |
| United States | Loyola University Health System | Maywood | Illinois |
| United States | The Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | Yale University | New Haven | Connecticut |
| United States | Tulane University | New Orleans | Louisiana |
| United States | NYU Medical Center | New York | New York |
| United States | Weill Medical College of Cornell University | New York | New York |
| United States | University of Oklahoma | Oklahoma City | Oklahoma |
| United States | Temple University | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | St. Joseph's Hospital | Phoenix | Arizona |
| United States | Oregon Clinic | Portland | Oregon |
| United States | University of California, Davis | Sacramento | California |
| United States | Washington University | Saint Louis | Missouri |
| United States | South Miami Hospital | South Miami | Florida |
| United States | Stanford University | Stanford | California |
| United States | University of South Florida | Tampa | Florida |
| United States | Renovatio Clinical | The Woodlands | Texas |
| United States | PMG Research | Wilmington | North Carolina |
| United States | Salem Chest &Southeastern Clinical Research Center | Winston-Salem | North Carolina |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Boehringer Ingelheim |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | 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) | |
| Secondary | 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) |