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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01915511
Recruitment Status : Recruiting
First Posted : August 5, 2013
Last Update Posted : December 9, 2022
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date July 31, 2013
First Posted Date August 5, 2013
Last Update Posted Date December 9, 2022
Study Start Date June 2014
Estimated Primary Completion Date January 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2019)
  • 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.
  • 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
  • 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).
  • 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 chronic fibrosing ILD) [ Time Frame: End of Study (3 years after last patient will be enrolled) ]
    Collect longitudinal HRCT images for future research
Original Primary Outcome Measures
 (submitted: August 1, 2013)
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: April 28, 2016)
  • 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.
Original Secondary Outcome Measures
 (submitted: August 1, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Official Title Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (IPF-PRO/ILD-PRO) Registry
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen 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.
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.
Condition Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 2, 2018)
2000
Original Estimated Enrollment
 (submitted: August 1, 2013)
300
Estimated Study Completion Date January 2028
Estimated Primary Completion Date January 2028   (Final data collection date for primary outcome measure)
Eligibility 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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rosalia Blanco 919-660-0890 rosalia.blanco@duke.edu
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01915511
Other Study ID Numbers Pro00046131
1199.174 ( Other Identifier: DCRI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators Boehringer Ingelheim
Investigators
Principal Investigator: Scott Palmer, MD Duke Clinical Research Institute, Duke University
PRS Account Duke University
Verification Date December 2022