Trial record 1 of 1 for:    NCT01915511
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Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 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: August 4, 2016
Last verified: April 2016
  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: 3 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: End of Study (3 years after last patient will be enrolled) ] [ 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: End of Study (3 years after last patient will be enrolled) ] [ 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: End of Study (3 years after last patient will be enrolled) ] [ Designated as safety issue: No ]
    Describe the impact of IPF on patient quality-of-life (QOL).

  • Blood samples for future research. [ Time Frame: End of Study (3 years after last patient will be enrolled) ] [ 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: End of Study (3 years after last patient will be enrolled) ] [ Designated as safety issue: No ]
    Compare disease-specific management practices with existing guidelines.

  • Data on center-specific practices on outcomes. [ Time Frame: End of Study (3 years after last patient will be enrolled) ] [ 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, serum, and RNA samples collected at enrollment and approximate 6-month intervals throughout study follow-up.

Estimated Enrollment: 1500
Study Start Date: June 2014
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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.
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 or older

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 ClinicalTrials.gov identifier: NCT01915511

Contacts
Contact: Rosalia Blanco 919-660-0890 rosalia.blanco@duke.edu

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mae Stewart    205-934-8666    mestewart@uabmc.edu   
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    ecallahan@mednet.ucla.edu   
Principal Investigator: John Belperio, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Kim Nguyen    650-723-0291    kvnguyen@stanford.edu   
Principal Investigator: Paul Mohabir, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Carol Bair    303-398-1912    BairC@NJHealth.org   
Principal Investigator: Tristan Huie, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Donna Carrano    203-785-4787    donna.carrano@yale.edu   
Principal Investigator: Mridu Gulati, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Spring Holland    773-834-4053    sholland@bsd.uchicago.edu   
Principal Investigator: Imre Noth, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Tamra Perez    502-852-1358    tamra.prez@louisville.edu   
Principal Investigator: Jesse Roman, MD         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sandy Ditta    504-988-4040    sditta@tulane.edu   
Principal Investigator: Joe Lasky, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Candace Flaherty    734-936-8301    cflah@med.umich.edu   
Principal Investigator: Kevin Flaherty, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Mandi DeGrote    612-626-7609    carl1032@umn.edu   
Principal Investigator: Hyum Kim, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Imaani Easthausen    212-305-9628    ije2103@cumc.columbia.edu   
Principal Investigator: David Lederer, MD         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Mei L Wang    646-962-4590    mew2001@med.cornell.edu   
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    rosemarie.smigla@duke.edu   
Principal Investigator: Lake Morrison, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ron Wehrmann    216-445-0574    wehrmar@ccf.org   
Principal Investigator: Daniel Culver, MD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gayle Jones    215-707-1041    gayle.jones@tuhs.temple.edu   
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    chambeam@musc.edu   
Principal Investigator: Timothy Whelan, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: James Del Greco    615-343-7068    james.del.greco@vanderbilt.edu   
Principal Investigator: Lisa Lancaster, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Khadija El Abdaimi    214-645-1295    Khadija.ElAbdaimi@UTSouthwestern.edu   
Principal Investigator: John Fitzgerald, MD         
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Investigators
Principal Investigator: Scott Palmer, MD Duke Clinical Research Institute, Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01915511     History of Changes
Other Study ID Numbers: Pro00046131  1199.174 
Study First Received: July 31, 2013
Last Updated: August 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Idiopathic pulmonary fibrosis
Pulmonary fibrosis
IPF
Registry
1199.174

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on August 25, 2016