Temple Health Chest Initiative (THCI 2.0)

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT06933758
• Lead Sponsor: Temple University

Brief Summary

Chronic obstructive pulmonary disease is highly prevalent globally, with considerable morbidity and mortality associated. In the US, it is the 4th leading cause of death, as well as contributing to significant costs on healthcare utilization including hospitalization. Population-based screening for COPD has not been recommended by the US Preventative Services Task Force (USPSTF). However, LDCT screening for lung cancer in patients aged 50- 80 with ≥ 20 pack year smoking has been shown to improve survival. COPD is highly prevalent within LCS programs, with estimated rates of obstructive lung function of up to 59% and evidence of emphysema on CT scan in around 70%.

Detailed Description

The rates of undiagnosed COPD are reported to be between 20 to 40% 1, 2, 3 with all GOLD stages of disease identified. Of those with no known diagnosis, up to 50% had symptoms consistent with COPD1. Currently, population-based screening is not recommended for COPD by the US Preventive Services Task Force (USPSTF)4. However, given the overlapping risk factors for COPD and lung cancer, there are existing opportunities to target identification of COPD within a high-risk group and build further understanding of the impact on outcomes of earlier diagnosis, phenotyping of disease and implementation of treatment. Screening for early lung cancer using low dose CT imaging also affords the opportunity to explore presence of comorbidities on images, such as presence and extent of emphysema and other lung parenchymal and airway abnormalities and coronary artery calcification. There is also an opportunity to explore the role of imaging biomarkers for COPD such as LAA and airway inflammation, in determining risk of disease progression through longitudinal observation.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study Start: 2025-02-28
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-05-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 50 to 80 years old
• Screened for early lung cancer using low dose CT imaging

Exclusion Criteria

• Under 50; over 80 years old
• No lung cancer screening

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPD Prevalence	15 months	Determine COPD prevalence utilizing \< 0.7 FEV1/FVC plus evidence of emphysema by quantitated HRCT in the THCI lung cancer screening population.

Secondary Outcome Measures

Name	Time	Method
Severity of COPD	15 months	Determine the severity of COPD identified by FEV1 % predicted
Demographic Characteristics	15 months	Describe demographics characteristics of THCI population
Incidence of Comorbid Lung and Non-lung Problems	15 months	Determine the incidence of comorbid lung (ILA, bronchiectasis, pulmonary artery; enlargement) and non-lung problems (cardiac and aortic calcifications,; osteopenia/osteoporosis and for gut abnormalities) identified by LDCT in a patient; population at risk for lung cancer and/or COPD

Trial Locations

Locations (1)

Temple University Of the Commonwealth System of Higher Education; 🇺🇸 Philadelphia, Pennsylvania, United States