Pulmonary Fibrosis Foundation Patient Registry

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

— PFFR  

Official title:

Pulmonary Fibrosis Foundation Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758808
• Other study ID #: PFF01
• Status: Completed
• Start date: March 29, 2016
• Est. completion date: December 16, 2022

Study information

• Verified date: July 2023
• Source: Pulmonary Fibrosis Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2004
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. 18 years old or older

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. Diagnosed with:

1. Sarcoid

2. Lymphangioleiomyomatosis (LAM)

3. Pulmonary alveolar proteinosis (PAP)

4. Cystic fibrosis (CF)

5. Amyloidosis

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Interstitial Lung Disease (ILD)
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Healthcare	Austell	Georgia
United States	Johns Hopkins University - School of Medicine	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University fo Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Interstitial Lung Disease Clinic	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	UCLA, David Geffen School of Medicine at UCLA	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Regents of the University of Minnesota Twin Cities	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Tulane University	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Temple University Health System	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Dignity Health St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	UTHSC - San Antonio	San Antonio	Texas
United States	University of California at San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	The University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Pulmonary Fibrosis Foundation	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in % predicted FVC	Analysis of registry data will lead to aggregated reports summarizing the pulmonary function	Up to 55 months
Primary	Change in % predicted DLCO	Analysis of registry data will lead to aggregated reports summarizing the pulmonary function	Up to 55 months