Advancing Prevention of Pulmonary Fibrosis

NCT ID: NCT04564183

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2026-08-01

Brief Summary

This study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred.

This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.

Conditions

IPF; Pulmonary Fibrosis; ILD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Full Cohort

Entire study population

Sample collection

Intervention Type: OTHER

Blood, Urine, Nail, Hair, Saliva, optional Stool

Questionnaires

Intervention Type: OTHER

SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire

High resolution CT scan of the chest

Intervention Type: RADIATION

Upon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.

Pulmonary Function Test

Intervention Type: DIAGNOSTIC_TEST

All recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.

Interventions

Sample collection

Blood, Urine, Nail, Hair, Saliva, optional Stool

Intervention Type: OTHER

Questionnaires

SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire

Intervention Type: OTHER

High resolution CT scan of the chest

Upon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.

Intervention Type: RADIATION

Pulmonary Function Test

All recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP)
• Age at least 40 years old and younger than 75 years old

Exclusion Criteria

• Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent
• Other genetic diseases associated with interstitial lung disease
• Pregnant women

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

20-1739

Identifier Type: -

Identifier Source: org_study_id