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Genetics of IPF - Screening Study for Family Members

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ClinicalTrials.gov Identifier: NCT03478553
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
United States Department of Defense
University of Alabama at Birmingham
National Jewish Health
Vanderbilt University
University of California, San Francisco
University of Pittsburgh
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis (IPF) Other: High Resolution CT scan of the chest Other: Blood draw Other: Questionnaire

Detailed Description:
The purpose of this study is to explore genetic factors associated with the development of pulmonary fibrosis. The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis. To investigate the genetics of pulmonary fibrosis, the investigators plan to enroll individuals with pulmonary fibrosis and their family members.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Idiopathic Pulmonary Fibrosis, a Disease Initiated by Mucociliary Dysfunction
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : September 29, 2021
Estimated Study Completion Date : September 29, 2021


Group/Cohort Intervention/treatment
People with IPF Other: Blood draw
Blood draw

Other: Questionnaire
Pulmonary Fibrosis Questionnaire

Family members without IPF Other: High Resolution CT scan of the chest
High Resolution CT scan of the chest

Other: Blood draw
Blood draw

Other: Questionnaire
Pulmonary Fibrosis Questionnaire




Primary Outcome Measures :
  1. Screen subjects for early Idiopathic Pulmonary Fibrosis (IPF) [ Time Frame: Baseline ]
    Subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis.


Biospecimen Retention:   Samples With DNA
Blood samples including DNA, RNA, Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will include 500 people with IPF and 500 of their siblings who have never been diagnosed with IPF.
Criteria

Inclusion Criteria:

  • Age at least 40 years old
  • Family member diagnosed with IPF

Exclusion Criteria:

- No family member with IPF


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478553


Contacts
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Contact: Julie Powers Becker, MHS 303-724-6539 julie.powers@ucdenver.edu
Contact: Alex M Jones, MSW 303-724-4025 alex.m.jones@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Alex M Jones, MSW    303-724-4025    alex.m.jones@ucdenver.edu   
Contact: Julie Powers, MHS    303-724-6539    julie.powers@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Defense
University of Alabama at Birmingham
National Jewish Health
Vanderbilt University
University of California, San Francisco
University of Pittsburgh
Investigators
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Principal Investigator: David A Schwartz, MD University of Colorado - Anschutz Medical Campus

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03478553     History of Changes
Other Study ID Numbers: 15-1147
W81XWH-17-1-0597_1a ( Other Grant/Funding Number: Department of Defense )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial