Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

This study is not yet open for participant recruitment.
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
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 April 15, 2014