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NCT06933758 | RECRUITING | Chronic Obstructive Pulmonary Disease (COPD)


Temple Health Chest Initiative (THCI 2.0)
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%.

Condition or disease

Chronic Obstructive Pulmonary Disease (COPD)

Intervention/treatment

Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio

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 Type : OBSERVATIONAL
Estimated Enrollment : 1000 participants
Official Title : Temple Health Chest Initiative (THCI 2.0) - Lung Cancer Screening Project With COPD Detection
Actual Study Start Date : 2025-02-28
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Temple Health Chest Initiative (THCI 2.0)

Location Details

NCT06933758


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Locations


RECRUITING

United States, Pennsylvania

Temple University Of the Commonwealth System of Higher Education

Philadelphia, Pennsylvania, United States, 19140

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