Clinical trial NCT06933758: Temple Health Chest Initiative (THCI 2.0)
Official title: Temple Health Chest Initiative (THCI 2.0) - Lung Cancer Screening Project With COPD Detection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 50 to 80 years old
* screened for early lung cancer using low dose CT imaging

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.

Eligibility criteria: 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

Primary outcomes:
measure: COPD Prevalence
timeFrame: 15 months
Secondary outcomes:
measure: Severity of COPD
timeFrame: 15 months
measure: Demographic Characteristics
timeFrame: 15 months
measure: Incidence of Comorbid Lung and Non-lung Problems
timeFrame: 15 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Of the Commonwealth System of Higher Education
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Gerard Criner, MD
role: PRINCIPAL_INVESTIGATOR
References: