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Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: November 14, 2014
Last verified: October 2014
  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: 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 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.


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)
Groups/Cohorts
Subjects with recent IPF diagnosis
Subjects who have been diagnosed with IPF in the 12 months preceding enrollment

  Eligibility

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 diagnosed with IPF in the 12 months preceding enrollment, identified at one of the enrolling tertiary care centers.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Malignancy, treated or untreated, other than skin cancer, within the past 5 years.
  • Currently listed for lung transplantation at the time of enrollment.
  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: Rex H Edwards 919-668-8499 rex.edwards@duke.edu

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Misty Purser    205-934-5573    mlpurser@mail.ad.uab.edu   
Principal Investigator: Joao deAndrade, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Valerie Snyder    303-270-2591    snyderv@njhealth.org   
Principal Investigator: Tristan Huie, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jean Estrom    203-785-7324    jean.estrom@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: Belicia Graf    502-852-8036    btgraf01@louisville.edu   
Principal Investigator: Jesse Roman, 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: Pat Carlson    612-625-2174    carls006@umn.edu   
Principal Investigator: Hyum Kim, 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 Not yet 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: Terrill Huggins, MD         
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Kathleen Kinser    615-343-7068    kathleen.j.kinser@vanderbilt.edu   
Principal Investigator: Mark Steele, MD         
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Barbi Lange    214-645-7101    barbi.lange@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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01915511     History of Changes
Other Study ID Numbers: Pro00046131
Study First Received: July 31, 2013
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014