Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)
This study is not yet open for participant recruitment.
Verified March 2014 by Duke University
Information provided by (Responsible Party):
First received: July 31, 2013
Last updated: March 3, 2014
Last verified: March 2014
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.
Idiopathic Pulmonary Fibrosis
||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:
||Prospective Outcomes Registry of Subjects With Idiopathic Pulmonary Fibrosis
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.
Biospecimen Retention: Samples With DNA
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.
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2019 (Final data collection date for primary outcome measure)
Subjects with recent IPF diagnosis
Subjects who have been diagnosed with IPF in the 12 months preceding enrollment
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects diagnosed with IPF in the 12 months preceding enrollment, identified at one of the enrolling tertiary care centers.
- 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
- Malignancy, treated or untreated, other than skin cancer, within the past 5 years.
- Currently listed for lung transplantation at the time of enrollment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915511
||Scott Palmer, MD
||Duke Clinical Research Institute, Duke University
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 31, 2013
||March 3, 2014
||United States: Institutional Review Board
Keywords provided by Duke University:
Idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial