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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• * Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent

Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials

Ability to tolerate study procedures

Ability to provide informed consent

Disqualifiers

Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; medium dose = >250 fluticasone propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS or

3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or

One asthma hospitalization in the past 12 months

Concurrent participation in a therapeutic trial where treatment is blinded

Trial population

Patients eligible for lung cancer screening due to their age and history of tobacco use, and have COPD, chronic bronchitis, or emphysema

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

COPD diagnosis based on meeting spirometric criteria

Will be based on meeting spirometric criteria for COPD (FEV\^1/FVC =\< 0.7) and have \>1% low attenuation area on low-dose CT for LCS

Time frame
2 years
2

Accrual rate

Will be reported using percentages and 95% exact confidence intervals.

Time frame
2 years
3

Intervention compliance rate

Will be reported using percentages and 95% exact confidence intervals.

Time frame
2 years
4

Follow-up retention rate

Will be reported using percentages and 95% exact confidence intervals.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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