Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 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: March 3, 2014
Last verified: March 2014
  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: 5 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: Up to 5 years ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Describe the impact of IPF on patient quality-of-life (QOL).

  • Blood samples for future research. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
    Collect longitudinal bio-samples for future research on disease presentation, progression, and subject response to clinical interventions.


Secondary Outcome Measures:
  • Data on clinical trial participation and management practices. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Compare disease-specific management practices with existing guidelines.

  • Data on center-specific practices on outcomes. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
    Determine the influence of center-specific practices on patient outcomes.


Biospecimen Retention:   Samples With DNA

Whole blood for DNA collected at enrollment. Plasma and serum samples collected at enrollment and approximate 6-month intervals throughout study follow-up.


Estimated Enrollment: 300
Study Start Date: April 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with recent IPF diagnosis
Subjects who have been diagnosed with IPF in the 12 months preceding enrollment

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with IPF in the 12 months preceding enrollment, identified at one of the enrolling tertiary care centers.

Criteria

Inclusion Criteria:

  • Ability to read and write in English
  • Willing and able to provide informed consent
  • Confirmed diagnosis of IPF by the enrolling facility in last 12 months
  • Age > 40 years

Exclusion Criteria:

  • Malignancy, treated or untreated, other than skin cancer, within the past 5 years.
  • Currently listed for lung transplantation at the time of enrollment.
  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: Rex H Edwards 919-668-8499 rex.edwards@duke.edu

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01915511     History of Changes
Other Study ID Numbers: Pro00046131
Study First Received: July 31, 2013
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014