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Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Duke University
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01915511
First received: July 31, 2013
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) 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.

Condition
Idiopathic Pulmonary Fibrosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prospective Outcomes Registry of Subjects With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Data on natural history of IPF. [ 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. [ Time Frame: End of Study (3 years after last patient will be enrolled) ]
    Understand the current practice patterns for diagnosis of IPF.

  • Data on impact of IPF 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.


Secondary Outcome Measures:
  • 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.


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.

Estimated Enrollment: 1500
Study Start Date: June 2014
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry are eligible for participation in the IPF-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

Exclusion Criteria:

  • Previously diagnosed with IPF by the enrolling subspecialty center. Only participants newly diagnosed with IPF will be included.
  • Malignancy, treated or untreated, other than skin cancer, within the past 5 years
  • Currently listed for lung transplantation at the time of enrollment
  • Currently enrolled in a randomized clinical trial at the time of enrollment in this registry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915511

Contacts
Contact: Rosalia Blanco 919-660-0890 rosalia.blanco@duke.edu

  Show 32 Study Locations
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Investigators
Principal Investigator: Scott Palmer, MD Duke Clinical Research Institute, Duke University
  More Information

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 )
Study First Received: July 31, 2013
Last Updated: April 6, 2017

Keywords provided by Duke University:
Idiopathic pulmonary fibrosis
Pulmonary fibrosis
IPF
Registry
1199.174

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

ClinicalTrials.gov processed this record on April 21, 2017