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

November 24, 2023 updated by: Duke University

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (IPF-PRO/ILD-PRO) Registry

This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.

Study Overview

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ponce, Puerto Rico, 00716
        • Completed
        • Ponce Research Institute
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama - Birmingham
        • Contact:
        • Principal Investigator:
          • Tracy Luckhardt, MD
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital
        • Principal Investigator:
          • Rajat Walia, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Toby Maher, MD
      • Los Angeles, California, United States, 90024
        • Recruiting
        • University of California - Los Angeles
        • Contact:
        • Principal Investigator:
          • John Belperio, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Principal Investigator:
          • Namita Sood, MD
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Rishi Raj, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Florida
      • South Miami, Florida, United States, 33143
        • Completed
        • South Miami Hospital
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Debabrata Bandyopadhyay, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Srihari Veeraraghavan, MD
      • Austell, Georgia, United States, 30106
        • Recruiting
        • Piedmont Healthcare
        • Principal Investigator:
          • Amy Case, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • Mary Strek, MD
      • Evanston, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Jane Dematte, MD
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Health System
        • Contact:
        • Principal Investigator:
          • Daniel Dilling, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas
        • Contact:
        • Principal Investigator:
          • Mark Hamblin, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Completed
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University
        • Principal Investigator:
          • Joe Lasky, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Burlington, Massachusetts, United States, 01803
        • Recruiting
        • Lahey Clinic
        • Contact:
        • Principal Investigator:
          • Timothy Liesching, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Kevin Flaherty, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Hyum Kim, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Principal Investigator:
          • Tonya Russell, MD
    • New York
      • Albany, New York, United States, 12208
        • Completed
        • Albany Medical Center
      • New York, New York, United States, 10016
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Medical College of Cornell University
        • Principal Investigator:
          • Robert Kaner, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Chapel Hill
        • Contact:
        • Principal Investigator:
          • Jason Lobo, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Lake Morrison, MD
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Pulmonix LLC
        • Principal Investigator:
          • Murali Ramaswamy, MD
        • Contact:
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Health
        • Contact:
        • Principal Investigator:
          • Andrew Namen, MD
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
        • Principal Investigator:
          • Nishant Gupta
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Briam Southern, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Contact:
        • Principal Investigator:
          • Jad Kebbe, MD
    • Oregon
      • Portland, Oregon, United States, 97220
        • Recruiting
        • Oregon Clinic
        • Principal Investigator:
          • David Hotchkin, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Mary Porteous, MD
      • Philadelphia, Pennsylvania, United States, 19144
      • Philadelphia, Pennsylvania, United States, 19140
        • Completed
        • Temple University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Timothy Whelan, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Lisa Lancaster, MD
    • Texas
      • Dallas, Texas, United States, 75235
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center at Dallas
        • Principal Investigator:
          • Yolanda Mageto, MD
        • Contact:
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Lung Center
        • Contact:
        • Principal Investigator:
          • Zeenat Safdar, MD
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Renovatio Clinical
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Vermont Lung Center
        • Contact:
        • Principal Investigator:
          • Marta Kokoszynska, MD
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Lynchburg Pulmonary Associates
        • Principal Investigator:
          • Albert Baker, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • The Medical College of Wisconsin
        • Principal Investigator:
          • Randolph Lipchik, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with a new diagnosis of IPF or a non- IPF chronic fibrosing ILD established at the time of enrollment in the registry are eligible for participation in the IPF-PRO/ILD-PRO registry if the participant meets the selection criteria.

Description

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
  • Age 30 years or older, or
  • 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

Exclusion Criteria:

  • Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
  • Currently listed for lung transplantation at the time of enrollment
  • Currently enrolled in a clinical trial at the time of enrollment in this registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry
Subjects with a non-IPF ILD diagnosis
Subjects with a 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data on natural history of IPF & non-IPF chronic fibrosing ILD
Time Frame: End of Study (3 years after last patient will be enrolled)
Characterize and describe the natural history of patients with a recent confirmed diagnosis of IPF, with emphasis on demographics, co-morbidities, medications, and risks for disease progression or death.
End of Study (3 years after last patient will be enrolled)
Data on current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD
Time Frame: End of Study (3 years after last patient will be enrolled)
Understand the current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD
End of Study (3 years after last patient will be enrolled)
Data on impact of IPF & non- IPF chronic fibrosing ILD on patient quality of life.
Time Frame: End of Study (3 years after last patient will be enrolled)
Describe the impact of IPF & non- IPF chronic fibrosing ILD on patient quality-of-life (QOL).
End of Study (3 years after last patient will be enrolled)
Blood samples for future research.
Time Frame: End of Study (3 years after last patient will be enrolled)
Collect longitudinal bio-samples for future research on disease presentation, progression, and subject response to clinical interventions.
End of Study (3 years after last patient will be enrolled)
HRCT images for future research (for non-IPF chronic fibrosing ILD)
Time Frame: End of Study (3 years after last patient will be enrolled)
Collect longitudinal HRCT images for future research
End of Study (3 years after last patient will be enrolled)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data on management practices compared to existing guidelines.
Time Frame: End of Study (3 years after last patient will be enrolled)
Compare disease-specific management practices with existing guidelines.
End of Study (3 years after last patient will be enrolled)
Data on center-specific practices on outcomes.
Time Frame: End of Study (3 years after last patient will be enrolled)
Determine the influence of center-specific practices on patient outcomes.
End of Study (3 years after last patient will be enrolled)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Scott Palmer, MD, Duke Clinical Research Institute, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

June 1, 2014

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimated)

August 5, 2013

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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