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

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ClinicalTrials.gov Identifier: NCT01915511
Recruitment Status : Active, not recruiting
First Posted : August 5, 2013
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry
Study Start Date : June 2014
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : December 2024


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



Primary Outcome Measures :
  1. Data on natural history of IPF & non-IPF 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.

  2. Data on current practice patterns for diagnosis of IPF & non-IPF 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 ILD

  3. Data on impact of IPF & non-IPF ILD on patient quality of life. [ Time Frame: End of Study (3 years after last patient will be enrolled) ]
    Describe the impact of IPF on patient quality-of-life (QOL).

  4. 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.

  5. HRCT images for future research (for non-IPF ILD patients) [ Time Frame: End of Study (3 years after last patient will be enrolled) ]
    Collect longitudinal HRCT images for future research


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
Whole blood for DNA collected at enrollment. Plasma, serum, and RNA samples collected at enrollment and approximate 6-month intervals throughout study follow-up.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a new diagnosis of IPF or a non-IPF 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.
Criteria

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 > 40 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915511


  Show 45 Study Locations
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Investigators
Principal Investigator: Scott Palmer, MD Duke Clinical Research Institute, Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01915511     History of Changes
Other Study ID Numbers: Pro00046131
1199.174 ( Other Identifier: DCRI )
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Duke University:
Idiopathic pulmonary fibrosis
Pulmonary fibrosis
IPF
Registry
1199.174
Interstitial Lung Disease
ILD
Interstitial Lung Disease with Progressive Phenotype

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases