Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)
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
|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|
- 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.
- 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.
|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)|
Subjects with recent IPF diagnosis
Subjects who have been diagnosed with IPF in the 12 months preceding enrollment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915511
|Contact: Rex H Edwardsfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama - Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Misty Purser 205-934-5573 email@example.com|
|Principal Investigator: Joao deAndrade, MD|
|United States, Colorado|
|National Jewish Health||Recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Valerie Snyder 303-270-2591 firstname.lastname@example.org|
|Principal Investigator: Tristan Huie, MD|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Spring Holland 773-834-4053 email@example.com|
|Principal Investigator: Imre Noth, MD|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Belicia Graf 502-852-8036 firstname.lastname@example.org|
|Principal Investigator: Jesse Roman, MD|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Candace Flaherty 734-936-8301 email@example.com|
|Principal Investigator: Kevin Flaherty, MD|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Pat Carlson 612-625-2174 firstname.lastname@example.org|
|Principal Investigator: Hyum Kim, MD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Contact: Rose Marie Smigla 919-681-3866 email@example.com|
|Principal Investigator: Lake Morrison, MD|
|United States, Ohio|
|Cleveland Clinic||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Ron Wehrmann 216-445-0574 firstname.lastname@example.org|
|Principal Investigator: Daniel Culver, MD|
|United States, Pennsylvania|
|Temple University||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: Gayle Jones 215-707-1041 email@example.com|
|Principal Investigator: Francis Cordova, MD|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Amy Chamberlain 843-792-3162 firstname.lastname@example.org|
|Principal Investigator: Terrill Huggins, MD|
|Principal Investigator:||Scott Palmer, MD||Duke Clinical Research Institute, Duke University|