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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research
The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research.
Patients who meet inclusion and exclusion criteria and are being treated at a Registry site can be asked to participate. Patients will be required to read and sign an Institutional review board(IRB)-approved informed consent document prior to any Registry activity taking place.
At the time of informed consent, participants will be asked to indicate if they are interested in being contacted by Registry site personnel for potential participation in future clinical trials and/or studies. Participants who opt out will not be contacted for future studies.
No clinical procedures, testing, or diagnostics will be required by virtue of Registry participation. Participants will permit Registry staff to abstract clinical data obtained as part of routine clinical care in the diagnosis and treatment of ILD. These data will be entered into a web-based, electronic data capture (EDC) by the Registry staff to at regular intervals. Some of these data will be retrospective, having been collected prior to consenting for the Registry.
Computed tomography (CT) images collected for diagnosis and / or treatment will be de-identified at the Registry site and uploaded to a secure server that is a 21 Code of Federal Regulations (CFR) Part 11, Good Clinical Practice (GCP), and HIPAA compliant online imaging repository.
Participants will be asked to complete patient reported outcome (PRO) surveys related to ILD symptoms and quality of life at the time of enrollment and during clinical follow-up visits.Participants who are not seen for clinical follow-up within 12 months will be contacted by telephone or mail by Registry site personnel to complete the PRO measures.
The University of Michigan Statistical Analysis of Biomedical and Educational Research (SABER) unit will serve as the Registry Data Coordinating Center and will manage data entered into a web based, CFR 21 Part 11 compliant electronic data capture (EDC) system by the Registry sites.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in % predicted FVC | Analysis of registry data will lead to aggregated reports summarizing the pulmonary function | Up to 55 months |
| Change in % predicted DLCO | Analysis of registry data will lead to aggregated reports summarizing the pulmonary function | Up to 55 months |
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Inclusion Criteria:
18 years old or older
Understand and sign the informed consent document
ILD Diagnosis must be made / confirmed at a participating Registry center.
Anticipated additional follow up at the Registry center within one year.
Exclusion Criteria:
1. Diagnosed with:
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At least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosos (IPF).
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| Name | Affiliation | Role |
|---|---|---|
| Kevin R Flaherty, MD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University fo Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Dignity Health St. Joseph's Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38386005 | Derived | Adegunsoye A, Bachman WM, Flaherty KR, Li Z, Gupta S. Use of Race-Specific Equations in Pulmonary Function Tests Impedes Potential Eligibility for Care and Treatment of Pulmonary Fibrosis. Ann Am Thorac Soc. 2024 Aug;21(8):1156-1165. doi: 10.1513/AnnalsATS.202309-797OC. | |
| 36481866 | Derived | Lee JS, Martin-Schwarze A, Freiheit E, Trzaskoma B, Burg C. Real-World Clinical Outcomes Based on Body Mass Index and Annualized Weight Change in Patients with Idiopathic Pulmonary Fibrosis. Adv Ther. 2023 Feb;40(2):691-704. doi: 10.1007/s12325-022-02382-0. Epub 2022 Dec 8. |
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whole blood, plasma, PAXgene
| Phoenix |
| Arizona |
| 85013 |
| United States |
| The University of Arizona | Tucson | Arizona | 85724-0001 | United States |
| UCLA, David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States |
| University of California at San Francisco | San Francisco | California | 94143-2204 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510-3206 | United States |
| University of Miami | Miami | Florida | 33138 | United States |
| Piedmont Healthcare | Austell | Georgia | 30106 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University - School of Medicine | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Regents of the University of Minnesota Twin Cities | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1010 | United States |
| Columbia University Medical Center | New York | New York | 10030 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794-8172 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| The Ohio State University | Columbus | Ohio | 43221 | United States |
| Pennsylvania State University | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19128 | United States |
| Temple University Health System | Philadelphia | Pennsylvania | 19129 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| UTHSC - San Antonio | San Antonio | Texas | 78253 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia Interstitial Lung Disease Clinic | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22046 | United States |
| University of Washington | Seattle | Washington | 98195-0001 | United States |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011658 | Pulmonary Fibrosis |
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