RECRUITING

Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects.

Official Title

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Interstitial Lung Disease Prospective Outcomes (IPF-PRO/ILD-PRO) Registry

Quick Facts

Study Start:2014-06
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01915511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide informed consent
  2. * Established a new diagnosis (within 12 months) of IPF by the enrolling center.
  3. * Age 21 years or older, or
  4. * Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype during the last 24 months by the enrolling center that meets the following criteria:
  5. * Chronic fibrosing ILD as defined by reticular abnormality with traction bronchiectasis with or without honeycombing confirmed by chest HRCT scan and/or lung biopsy.
  6. * Progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs (8):
  7. * decline in FVC % predicted (% pred) based on ≥10% relative decline
  8. * decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator
  9. * decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator
  10. * decline in DLCO % pred based on≥ 10% relative decline
  11. * worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change.
  1. * Malignancy, treated or untreated, other than skin or early -stage prostate cancer, within the past 5 years
  2. * Currently listed for lung transplantation at the time of enrollment
  3. * Currently enrolled in an interventional clinical trial at the time of enrollment in this registry
  4. * For the additional IPF cohort of 1000 individuals, previous enrollment in this registry.

Contacts and Locations

Study Contact

Rosalia Blanco
CONTACT
919-660-0890
rosalia.blanco@duke.edu

Principal Investigator

Scott Palmer, MD
PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute, Duke University

Study Locations (Sites)

University of Alabama - Birmingham
Birmingham, Alabama, 35294
United States
University of California - Los Angeles
Los Angeles, California, 90024
United States
University of Southern California
Los Angeles, California, 90033
United States
University of California, Davis
Sacramento, California, 95817
United States
Stanford University
Stanford, California, 94305
United States
Yale University
New Haven, Connecticut, 06520
United States
University of South Florida
Tampa, Florida, 33606
United States
Emory University
Atlanta, Georgia, 30322
United States
Piedmont Healthcare
Austell, Georgia, 30106
United States
University of Chicago
Chicago, Illinois, 60637
United States
Northwestern University
Evanston, Illinois, 60611
United States
Loyola University Health System
Maywood, Illinois, 60153
United States
University of Kansas
Kansas City, Kansas, 66160
United States
Tulane University
New Orleans, Louisiana, 70112
United States
University from Virginia
Baltimore, Maryland, 21201
United States
Lahey Clinic
Burlington, Massachusetts, 01803
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Washington University
Saint Louis, Missouri, 63110
United States
NYU Medical Center
New York, New York, 10016
United States
Weill Medical College of Cornell University
New York, New York, 10065
United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Duke University
Durham, North Carolina, 27705
United States
Pulmonix LLC
Greensboro, North Carolina, 27403
United States
PMG Research
Wilmington, North Carolina, 28401
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Oregon Clinic
Portland, Oregon, 97220
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
University of Texas Southwestern
Dallas, Texas, 75235
United States
Baylor University Medical Center at Dallas
Dallas, Texas, 75246
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist Lung Center
Houston, Texas, 77030
United States
Vermont Lung Center
Burlington, Vermont, 05401
United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Duke University

  • Scott Palmer, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-06
Study Completion Date2028-01

Study Record Updates

Study Start Date2014-06
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Idiopathic pulmonary fibrosis
  • Pulmonary fibrosis
  • IPF
  • Registry
  • 1199.174
  • Interstitial Lung Disease
  • ILD
  • Interstitial Lung Disease with Progressive Phenotype

Additional Relevant MeSH Terms

  • Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease