Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

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.

Conditions

Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

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Study Overview

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Study Details

Study overview

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.

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

Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

Condition
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama - Birmingham, Birmingham, Alabama, United States, 35294

Los Angeles

University of California - Los Angeles, Los Angeles, California, United States, 90024

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

Stanford

Stanford University, Stanford, California, United States, 94305

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Tampa

University of South Florida, Tampa, Florida, United States, 33606

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Austell

Piedmont Healthcare, Austell, Georgia, United States, 30106

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Willing and able to provide informed consent
  • * Established a new diagnosis (within 12 months) of IPF by the enrolling center.
  • * Age 21 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 during the last 24 months by the enrolling center that meets the following criteria:
  • * Chronic fibrosing ILD as defined by reticular abnormality with traction bronchiectasis with or without honeycombing confirmed by chest HRCT scan and/or lung biopsy.
  • * 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):
  • * decline in FVC % predicted (% pred) based on ≥10% relative decline
  • * decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator
  • * 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
  • * decline in DLCO % pred based on≥ 10% relative decline
  • * 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.
  • * 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 an interventional clinical trial at the time of enrollment in this registry
  • * For the additional IPF cohort of 1000 individuals, previous enrollment in this registry.

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

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

Study Record Dates

2028-01