Advancing Prevention of Pulmonary Fibrosis

NCT04564183 | Active Not Recruiting

• 1 other identifier: 20-1739
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest

  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.

  Baseline

Study Arms (1)

Full Cohort

Entire study population

Other: Sample collection; Other: Questionnaires; Radiation: High resolution CT scan of the chest; Diagnostic Test: Pulmonary Function Test

Interventions

Sample collection OTHER

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

Full Cohort

Questionnaires OTHER

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

Full Cohort

High resolution CT scan of the chest 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.

Full Cohort

Pulmonary Function Test 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.

Full Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Mayo Clinic: collaborator
• University of California, Los Angeles: collaborator
• University of Texas: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Specimen Handling; Surveys and Questionnaires; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Diagnostic Techniques, Respiratory System

Study Officials

• David Schwartz, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 25, 2020
• Study Start: January 22, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)