Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Duke University
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University Identifier:
First received: July 31, 2013
Last updated: September 8, 2015
Last verified: September 2015
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

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 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)
Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry.


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 with a new diagnosis of IPF established at the time of enrollment in the registry are eligible for participation in the IPF-PRO registry if the participant meets the selection criteria.

Inclusion Criteria:

  • Ability to read and write in English
  • Willing and able to provide informed consent
  • Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
  • Age > 40 years

Exclusion Criteria:

  • Previously diagnosed with IPF by the enrolling subspecialty center. Only participants newly diagnosed with IPF will be included.
  • Malignancy, treated or untreated, other than skin cancer, within the past 5 years
  • Currently listed for lung transplantation at the time of enrollment
  • Currently enrolled in a randomized clinical trial at the time of enrollment in this registry
  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 identifier: NCT01915511

Contact: Rosalia Blanco 919-668-0890

United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Misty Purser    205-934-5573   
Principal Investigator: Joao deAndrade, MD         
United States, California
University of California - Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Eileen Callahan    310-794-2466   
Principal Investigator: John Belperio, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Susan Jacobs    650-725-8083   
Principal Investigator: Paul Mohabir, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Valerie Snyder    303-270-2591   
Principal Investigator: Tristan Huie, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jean Estrom    203-785-7324   
Principal Investigator: Mridu Gulati, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Spring Holland    773-834-4053   
Principal Investigator: Imre Noth, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Belicia Graf    502-852-8036   
Principal Investigator: Jesse Roman, MD         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sandy Ditta    504-988-4040   
Principal Investigator: Joe Lasky, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Candace Flaherty    734-936-8301   
Principal Investigator: Kevin Flaherty, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Pat Carlson    612-625-2174   
Principal Investigator: Hyum Kim, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Tatiana Blue    212-342-4167   
Principal Investigator: David Lederer, MD         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Aileen L Orpilla    646-962-5568   
Principal Investigator: Robert Kaner, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Rose Marie Smigla    919-681-3866   
Principal Investigator: Lake Morrison, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ron Wehrmann    216-445-0574   
Principal Investigator: Daniel Culver, MD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gayle Jones    215-707-1041   
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   
Principal Investigator: Timothy Whelan, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kathleen Kinser    615-343-7068   
Principal Investigator: Mark Steele, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Barbi Lange    214-645-7101   
Principal Investigator: John Fitzgerald, MD         
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Principal Investigator: Scott Palmer, MD Duke Clinical Research Institute, Duke University
  More Information

No publications provided

Responsible Party: Duke University Identifier: NCT01915511     History of Changes
Other Study ID Numbers: Pro00046131
Study First Received: July 31, 2013
Last Updated: September 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Idiopathic pulmonary fibrosis
Pulmonary fibrosis

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases processed this record on December 01, 2015