Trial record 1 of 1 for:
Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)
Verified September 2014 by Duke University
Information provided by (Responsible Party):
First received: July 31, 2013
Last updated: September 11, 2014
Last verified: September 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.
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
|University of Alabama - Birmingham
|Birmingham, Alabama, United States, 35294 |
|Contact: Misty Purser 205-934-5573 firstname.lastname@example.org |
|Principal Investigator: Joao deAndrade, MD |
|University of Chicago
|Chicago, Illinois, United States, 60637 |
|Contact: Spring Holland 773-834-4053 email@example.com |
|Principal Investigator: Imre Noth, MD |
|University of Michigan
|Ann Arbor, Michigan, United States, 48109 |
|Contact: Candace Flaherty 734-936-8301 firstname.lastname@example.org |
|Principal Investigator: Kevin Flaherty, MD |
|Durham, North Carolina, United States, 27705 |
|Contact: Rose Marie Smigla 919-681-3866 email@example.com |
|Principal Investigator: Lake Morrison, MD |
|Medical University of South Carolina
|Charleston, South Carolina, United States, 29425 |
|Contact: Amy Chamberlain 843-792-3162 firstname.lastname@example.org |
|Principal Investigator: Terrill Huggins, MD |
||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
||September 11, 2014
||United States: Institutional Review Board
Keywords provided by Duke University:
Idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial