NCT02758808

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

42 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

6.7 years

First QC Date

April 14, 2016

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

University fo Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

The University of Arizona

Tucson, Arizona, 85724-0001, United States

Location

UCLA, David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

University of California at San Francisco

San Francisco, California, 94143-2204, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510-3206, United States

Location

University of Miami

Miami, Florida, 33138, United States

Location

Piedmont Healthcare

Austell, Georgia, 30106, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University - School of Medicine

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Regents of the University of Minnesota Twin Cities

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Columbia University Medical Center

New York, New York, 10030, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794-8172, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19128, United States

Location

Temple University Health System

Philadelphia, Pennsylvania, 19129, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

UTHSC - San Antonio

San Antonio, Texas, 78253, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia Interstitial Lung Disease Clinic

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22046, United States

Location

University of Washington

Seattle, Washington, 98195-0001, United States

Location

Related Publications (2)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, PAXgene

MeSH Terms

Conditions

Lung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPulmonary Fibrosis

Study Officials

  • Kevin R Flaherty, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

April 14, 2016

First Posted

May 3, 2016

Study Start

March 29, 2016

Primary Completion

December 16, 2022

Study Completion

December 16, 2022

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations