PFFR: Pulmonary Fibrosis Foundation Patient Registry

Sponsor

University of Michigan (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02758808

Collaborator

Pulmonary Fibrosis Foundation (Other)

2,004

Enrollment

Locations

Duration (Months)

47.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease (ILD) Idiopathic Pulmonary Fibrosis (IPF)

Detailed Description

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2004 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pulmonary Fibrosis Foundation Patient Registry

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 16, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

Change in % predicted FVC [Up to 55 months]
Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Change in % predicted DLCO [Up to 55 months]
Analysis of registry data will lead to aggregated reports summarizing the pulmonary function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

Exclusion Criteria:

Diagnosed with:
Sarcoid
Lymphangioleiomyomatosis (LAM)
Pulmonary alveolar proteinosis (PAP)
Cystic fibrosis (CF)
Amyloidosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University fo Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Dignity Health St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
3	The University of Arizona	Tucson	Arizona	United States	85724-0001
4	UCLA, David Geffen School of Medicine at UCLA	Los Angeles	California	United States	90095
5	University of California at San Francisco	San Francisco	California	United States	94143-2204
6	Stanford University	Stanford	California	United States	94305
7	National Jewish Health	Denver	Colorado	United States	80206
8	Yale School of Medicine	New Haven	Connecticut	United States	06510-3206
9	University of Miami	Miami	Florida	United States	33138
10	Piedmont Healthcare	Austell	Georgia	United States	30106
11	Northwestern University	Chicago	Illinois	United States	60611
12	University of Chicago	Chicago	Illinois	United States	60637
13	The University of Kansas Medical Center	Kansas City	Kansas	United States	66160
14	University of Louisville	Louisville	Kentucky	United States	40202
15	Tulane University	New Orleans	Louisiana	United States	70112
16	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
17	Johns Hopkins University - School of Medicine	Baltimore	Maryland	United States	21205
18	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
19	University of Michigan	Ann Arbor	Michigan	United States	48109
20	Regents of the University of Minnesota Twin Cities	Minneapolis	Minnesota	United States	55455
21	Mayo Clinic	Rochester	Minnesota	United States	55905
22	Washington University School of Medicine	Saint Louis	Missouri	United States	63110-1010
23	Columbia University Medical Center	New York	New York	United States	10030
24	Weill Cornell Medical College	New York	New York	United States	10065
25	University of Rochester	Rochester	New York	United States	14642
26	Stony Brook University Hospital	Stony Brook	New York	United States	11794-8172
27	Duke University Medical Center	Durham	North Carolina	United States	27710
28	University of Cincinnati	Cincinnati	Ohio	United States	45267
29	The Ohio State University	Columbus	Ohio	United States	43221
30	Pennsylvania State University	Hershey	Pennsylvania	United States	17033
31	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19128
32	Temple University Health System	Philadelphia	Pennsylvania	United States	19129
33	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
34	Medical University of South Carolina	Charleston	South Carolina	United States	29425
35	Vanderbilt University	Nashville	Tennessee	United States	37232
36	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
37	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
38	UTHSC - San Antonio	San Antonio	Texas	United States	78253
39	University of Utah	Salt Lake City	Utah	United States	84108
40	University of Virginia Interstitial Lung Disease Clinic	Charlottesville	Virginia	United States	22908
41	Inova Fairfax Hospital	Falls Church	Virginia	United States	22046
42	University of Washington	Seattle	Washington	United States	98195-0001