Genetics of IPF - Screening Study for Family Members

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03478553
• Collaborator: United States Department of Defense (U.S. Fed), University of Alabama at Birmingham (Other), National Jewish Health (Other), University of California, San Francisco (Other), University of Pittsburgh (Other), Baylor University (Other)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 56.3
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Jan 18, 2018
• Anticipated Primary Completion Date: Sep 29, 2022
• Anticipated Study Completion Date: Sep 29, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Screen subjects for early Idiopathic Pulmonary Fibrosis (IPF) [Baseline]

   Subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age at least 40 years old

• Family member diagnosed with IPF

Exclusion Criteria:

• No family member with IPF

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• United States Department of Defense
• University of Alabama at Birmingham
• National Jewish Health
• University of California, San Francisco
• University of Pittsburgh
• Baylor University

Investigators

• Principal Investigator: David A Schwartz, MD, University of Colorado - Anschutz Medical Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03478553
• Other Study ID Numbers: 15-1147; W81XWH-17-1-0597_1a
• First Posted: Mar 27, 2018
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Oct 1, 2021