NCT06974981

Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening. Clinical information will be obtained from study participants including symptom burden, lung cancer risk, spirometry, imaging characteristics, and peripheral blood eosinophils.

Detailed description

This study is a prospective cohort study and aims to characterize COPD and lung cancer screening outcomes among individuals receiving lung cancer screening, with the primary objective of determining feasibility of an LCS-facilitated process for identifying COPD cases. The investigators anticipate enrolling 420 participants over 2 years. All study participants will undergo collection of clinical data at baseline and at 12-15 months. Study procedures at baseline include a blood draw for complete blood count (if not available within the prior 30 days), Pulmonary Function Testing (PFT) for spirometry and six-minute walk test (if not available within the prior 12 months). All participants will receive standard of care low-dose CT for lung cancer screening through Jefferson's LCS Program. Study participants will also complete surveys at baseline including: * Respiratory Medication Use Questionnaire * Respiratory Disease and Smoke Exposure Questionnaire * CAPTURE Questionnaire * COPD Assessment Test * CAPTURE Questionnaire Potential participants will be recruited through the Jefferson LCS Program. The LCS Program clinical nurse navigator and research nurse navigator will assess eligibility at the time of referral to the LCS Program. Participants who have already had a PFT within 12 months will be consented and enrolled at their standard of care LCS Program appointment. The blood draw (if needed) and study questionnaires will be done immediately following the LCS Program appointment. Participants who need a first-time or updated PFT will be scheduled for a separate visit with the research nurse to provide consent, enroll on the study, and perform all study procedures. Study participants will be followed for at least 15 months (to ascertain LCS annual adherence, defined as a repeat LDCT within 11-15 months of the prior LDCT). After enrollment completion, the Jefferson cohort will be combined with a cohort at the University of Michigan (MAP2 study, estimated n=200)

Conditions

• COPD
• Chronic Obstructive Pulmonary Disease

Timeline

• Start date: 2025-01-02
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2025-05-16
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States