APPLe: Advancing Prevention of Pulmonary Fibrosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Full Cohort Entire study population |
Other: Sample collection
Blood, Urine, Nail, Hair, Saliva, optional Stool
Other: Questionnaires
SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire
Radiation: 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.
Diagnostic Test: 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.
|
| Sub-Cohort Randomly selected sub-cohort from the larger group of all participants |
Other: Sample collection
Blood, Urine, Nail, Hair, Saliva, optional Stool
Other: Questionnaires
SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire
Radiation: 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.
Diagnostic Test: 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.
|
Outcome Measures
Primary Outcome Measures
- Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest [Baseline]
All subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis. CT scans will be evaluated by study radiologists.
Eligibility Criteria
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
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
- Mayo Clinic
- University of California, Los Angeles
- University of Texas
- University of Pennsylvania
Investigators
- Principal Investigator: David Schwartz, MD, University of Colorado School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-1739