Interstitial Lung Disease (ILD)PFFRNCT02758808
Pulmonary Fibrosis Foundation Patient Registry
An observational study of Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF), run by Pulmonary Fibrosis Foundation at 42 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
- How many people
- 2,004 participants
- Where
- 42 sitesUnited States
- Study dates
- 29 Mar 2016to 16 Dec 2022
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 18 years old or older
- Understand and sign the informed consent document
- ILD Diagnosis must be made / confirmed at a participating Registry center.
- 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.
- If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
- Anticipated additional follow up at the Registry center within one year.
Who cannot join
- 1. Diagnosed with:
- Sarcoid
- Lymphangioleiomyomatosis (LAM)
- Pulmonary alveolar proteinosis (PAP)
- Cystic fibrosis (CF)
- Amyloidosis
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Healthcare
Austell, Georgia, 30106
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins University - School of Medicine
Baltimore, Maryland, 21205
University fo Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Interstitial Lung Disease Clinic
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
The Ohio State University
Columbus, Ohio, 43221
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22046
Pennsylvania State University
Hershey, Pennsylvania, 17033
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
The University of Kansas Medical Center
Kansas City, Kansas, 66160
UCLA, David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33138
Regents of the University of Minnesota Twin Cities
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
Yale School of Medicine
New Haven, Connecticut, 06510-3206
Tulane University
New Orleans, Louisiana, 70112
Columbia University Medical Center
New York, New York, 10030
Weill Cornell Medical College
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19128
Temple University Health System
Philadelphia, Pennsylvania, 19129
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84108
UTHSC - San Antonio
San Antonio, Texas, 78253
University of California at San Francisco
San Francisco, California, 94143-2204
University of Washington
Seattle, Washington, 98195-0001
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Stanford University
Stanford, California, 94305
Stony Brook University Hospital
Stony Brook, New York, 11794-8172
The University of Arizona
Tucson, Arizona, 85724-0001
About this study
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
Read the detailed description
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.
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % predicted FVC
Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Measured: Up to 55 months
Change in % predicted DLCO
Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Measured: Up to 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start29 Mar 2016
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,004 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Pulmonary Fibrosis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Kevin Flaherty, MD, MS, Pulmonary Fibrosis Foundation
- Investigators
- Kevin R Flaherty, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758808
- Sponsor's protocol ID
- PFF01
- Acronym
- PFFR
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2016
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kang M, Gupta S, Tu YH, Raimundo K, Patel AM, Flaherty KR. Impact of Pirfenidone on Patient-Reported Outcomes in Patients With Idiopathic Pulmonary Fibrosis From the Pulmonary Fibrosis Foundation Patient Registry. CHEST Pulm. 2024 Jul 6;2(4):100082. doi: 10.1016/j.chpulm.2024.100082. eCollection 2024 Dec.
PubMed 42548421Adegunsoye 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.
PubMed 38386005Lee 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.
PubMed 36481866
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Fibrosis Foundation Patient Registry
- ClinicalTrials.gov ID
- NCT02758808
- Acronym / sponsor ID
- PFFR / PFF01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- Pulmonary Fibrosis FoundationUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Sarcoid
- Lymphangioleiomyomatosis (LAM)
- Pulmonary alveolar proteinosis (PAP)
- Cystic fibrosis (CF)
- Amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in % predicted FVC
Time frame: Up to 55 months
Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Change in % predicted DLCO
Time frame: Up to 55 months
Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 42548421Kang M, Gupta S, Tu YH, Raimundo K, Patel AM, Flaherty KR. Impact of Pirfenidone on Patient-Reported Outcomes in Patients With Idiopathic Pulmonary Fibrosis From the Pulmonary Fibrosis Foundation Patient Registry. CHEST Pulm. 2024 Jul 6;2(4):100082. doi: 10.1016/j.chpulm.2024.100082. eCollection 2024 Dec.
- Derived from this study: PubMed 38386005Adegunsoye 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.
- Derived from this study: PubMed 36481866Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin R Flaherty, MD study chair
University of Michigan
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF), run by Pulmonary Fibrosis Foundation at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % predicted FVC (time frame: Up to 55 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758808, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.