Temple Health Chest Initiative (THCI 2.0)

Temple Health Chest Initiative (THCI 2.0) - Lung Cancer Screening Project With COPD Detection

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%.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Diagnostic test: 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
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Lauren Miller, BS; Phone Number: 215-707-4821; Email: lauren.e.miller@temple.edu
• Study Contact Backup: Name: Stephanie Yerkes, BA; Phone Number: 215-707-2357; Email: stephanie.yerkes@temple.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University of The Commonwealth System of Higher Education
      • Contact: Lauren Miller, BS; Phone Number: 215-707-4821; Email: lauren.e.miller@temple.edu
      • Contact: Stephanie Yerkes, BA; Phone Number: 215-707-2357; Email: stephanie.yerkes@temple.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pulmonary function testing; If the patient does have airflow obstruction (any severity) they will be contacted to complete additional questionnaires.

Diagnostic test: Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio; Demonstrate utility of LDCT in COPD characterization Determine exacerbation risk and symptom burden in this patient population Determine the severity of COPD identified through this process Describe phenotypic characteristics including imaging analysis of THCI population Determine the suitability and acceptance of patients to participate in COPD clinical trials 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 Determine the correlation between clinical measurements and imaging biomarkers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of COPD	Determine the severity of COPD identified by FEV1 % predicted	15 months
Demographic Characteristics	Describe demographics characteristics of THCI population	15 months
Incidence of Comorbid Lung and Non-lung Problems	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	15 months

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Gerard Criner, MD, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: THCI 2.0 RESEARCH PLAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No