Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT06933758

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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%.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study ID

NCT06933758

Start date

Feb 28, 2025

Status verified date

Jan, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Pulmonary function testing

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

Interventions

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

Primary outcome measure

  • COPD Prevalence [ Time Frame: 15 months ]

Central Contacts and Locations

Central contacts

Lauren Miller, BS

215-707-4821lauren.e.miller@temple.edu

Stephanie Yerkes, BA

215-707-2357stephanie.yerkes@temple.edu

Locations

Temple University Of the Commonwealth System of Higher Education

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Lauren Miller, BS

215-707-4821lauren.e.miller@temple.edu

Stephanie Yerkes, BA

215-707-2357stephanie.yerkes@temple.edu

More Information

Sponsor

Temple University

Last update posted

Apr 18, 2025

Last verified

Jan, 2025

Keywords

  • COPD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Temple University on 2025-04-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.