Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2004 participants
OBSERVATIONAL
2016-03-29
2022-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Understand and sign the informed consent document
3. ILD Diagnosis must be made / confirmed at a participating Registry center.
1. The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest.
2. If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
4. Anticipated additional follow up at the Registry center within one year.
Exclusion Criteria
1. Sarcoid
2. Lymphangioleiomyomatosis (LAM)
3. Pulmonary alveolar proteinosis (PAP)
4. Cystic fibrosis (CF)
5. Amyloidosis
18 Years
99 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Pulmonary Fibrosis Foundation
OTHER
Responsible Party
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Kevin Flaherty, MD, MS
Chief Medical Officer
Principal Investigators
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Kevin R Flaherty, MD
Role: STUDY_CHAIR
University of Michigan
Locations
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University fo Alabama at Birmingham
Birmingham, Alabama, United States
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
The University of Arizona
Tucson, Arizona, United States
UCLA, David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Piedmont Healthcare
Austell, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins University - School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Regents of the University of Minnesota Twin Cities
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
UTHSC - San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Interstitial Lung Disease Clinic
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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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.
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.
Other Identifiers
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PFF01
Identifier Type: -
Identifier Source: org_study_id
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