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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

July 31, 2013
August 5, 2013
November 6, 2018
June 2014
November 2024   (Final data collection date for primary outcome measure)
  • 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.
  • 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
  • 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).
  • 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.
  • 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
  • Data on natural history of IPF. [ Time Frame: Up to 5 years ]
    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.
  • Data on current practice patterns for diagnosis of IPF. [ Time Frame: Up to 5 years. ]
    Understand the current practice patterns for diagnosis of IPF.
  • Data on impact of IPF on patient quality of life. [ Time Frame: Up to 5 years. ]
    Describe the impact of IPF on patient quality-of-life (QOL).
  • Blood samples for future research. [ Time Frame: Up to 5 years. ]
    Collect longitudinal bio-samples for future research on disease presentation, progression, and subject response to clinical interventions.
Complete list of historical versions of study NCT01915511 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Data on clinical trial participation and management practices. [ Time Frame: Up to 5 years ]
    Identify factors associated with participation in interventional clinical trials, as part of a patient's care plan.
  • Data on management practices compared to existing guidelines. [ Time Frame: Up to 5 years. ]
    Compare disease-specific management practices with existing guidelines.
  • Data on center-specific practices on outcomes. [ Time Frame: Up to 5 years. ]
    Determine the influence of center-specific practices on patient outcomes.
Not Provided
Not Provided
 
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (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.
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Years
Retention:   Samples With DNA
Description:
Whole blood for DNA collected at enrollment. Plasma, serum, and RNA samples collected at enrollment and approximate 6-month intervals throughout study follow-up.
Non-Probability Sample
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.
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Not Provided
  • 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
O'Brien EC, Durheim MT, Gamerman V, Garfinkel S, Anstrom KJ, Palmer SM, Conoscenti CS. Rationale for and design of the Idiopathic Pulmonary Fibrosis-PRospective Outcomes (IPF-PRO) registry. BMJ Open Respir Res. 2016 Jan 11;3(1):e000108. doi: 10.1136/bmjresp-2015-000108. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2000
300
December 2024
November 2024   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01915511
Pro00046131
1199.174 ( Other Identifier: DCRI )
No
Not Provided
Not Provided
Duke University
Duke University
Boehringer Ingelheim
Principal Investigator: Scott Palmer, MD Duke Clinical Research Institute, Duke University
Duke University
November 2018