CHAMP Lung Cancer Screening Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-77
SponsorJill Kolesar
About this trial
The U.S. Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose CT for adults aged 50-80 with a ≥20 pack-year smoking history who currently smoke or quit within the past 15 years. Despite insurance coverage, only 17% of eligible Iowans were screened in 2024. Barriers include the complexity of screening and competing demands in primary care. To address these challenges, investigators propose a two-part intervention: a blood-based screening test to simplify LCS and a community pharmacist-led referral program integrated into routine pharmacy care.
Eligible patients will be identified at Greenwood Pharmacy in Waterloo, Iowa. Interested individuals will be consented by a pharmacist and engaged in shared decision-making about LCS. Participants may decline screening, complete the DELFI Diagnostics FirstLook lung cancer screening blood test, or pursue CT screening through their primary care physician. Those choosing the blood test will be referred to Cedar Valley Family Medicine. Patients with a positive result will complete a standard shared decision-making visit with their PCP and, if appropriate, undergo confirmatory CT imaging. Patients with a negative result will enter a screening cohort and be re-screened annually for an additional year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 50-77
smoking pack-year history of ≥ 20 years
current smoker or quit smoking 15 or less years ago
ability to understand and willingness to sign a written informed consent document
Disqualifiers
self-report of lung cancer screening in the last 12 months
psychiatric illness/social situations that would limit compliance with study requirements
Trial design
Design model
Parallel
Treatments tested in this trial
DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test
Diagnostic testA participant can choose to receive this test. This is done by receiving a blood draw. The blood sample is sent to the DELFI Diagnositics lab without any personal health information attached. Results will be relayed to the participant as either "elevated" or "not elevated". IF the result is "elevated" the participant will be recommended to receive a low-dose CT scan.
Low-Does CT Scan
Diagnostic testIf a participant chooses this arm, the participant will request their primary care physician to order them a low-dose CT scan as part of the USPSTF standards for lung cancer screening. Participants will be asked to fax the results of those scans to the study.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: DELFI FirstLook Lung Cancer Screening Blood TestExperimental treatment 1 intervention
Group B: Low-Dose CTActive comparator 1 intervention
Group C: No lung cancer screeningNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of pharmacy patrons receiving lung cancer screening
To determine the proportion of pharmacy patrons eligible for lung cancer screening who accept a pharmacist's recommendation for screening and subsequently undergo lung cancer screening.
Time frame
From enrollment through six months after enrollmentSecondary outcomes
1
Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test
What proportion of enrolled participants choose to receive a DELFI Diagnostics FirstLook lung cancer screening blood test as their lung cancer screening option.
Time frame
From enrollment through six months after enrollment2
Determine the proportion of eligible participants that receive a low-dose CT scan
What proportion of eligible participants offered lung cancer screening by a pharmacist accept the recommendation and undergo lung cancer screening by low-dose CT scan.
Time frame
From enrollment through six months after enrollment3
Correlations between demographic data and declining of initial screening
Correlations between demographic factors and declining of initial screening will be assessed univariably using two-sample t-tests for quantitative factors and Pearson's chi-squared tests for qualitative factors. The sample size is expected to be large enough to justify the distributional assumptions of these tests, but if that is not the case, then non-parametric Wilcoxon rank-sum and Fisher's exact tests will be used instead. Multivariable effects of demographic factors will be modeled with logistic regression. Frequency of year 2 and 3 completion of screening will be estimated with binomial proportions.
Time frame
From time of enrollment through 30 days after enrollment4
Frequency of individuals who complete screening in year 1 that return for screening in year 2
Determine the frequency of individuals who complete screening in year 1 that return for screening in year 2.
Time frame
From 12 through 18 months after initial enrollmentOther outcomes
1
Rate of positive DELFI Diagnostics FirstLook lung cancer screening tests
Determine the rate of positive DELFI tests.
Time frame
From enrollment through 12 months after enrollment2
Diagnostic CT completion rate among participants with a positive DELFI Diagnostics FirstLook lung cancer screening test
Determine what percentage of participants with a positive DELFI Diagnostics FirstLook lung cancer screening test complete the recommended low-dose CT scan.
Time frame
From time of positive DELFI test through 12 months after test results3
Percentage of participants diagnosed with lung cancer
Determine percentage of participants diagnosed with lung cancer among those ultimately completing diagnostic CT scans.
Time frame
From time of CT scan until completion of study, up to three years4
Positive DELFI Diagnostics Firstlook lung cancer screening test correlation to clinical demographics and lung cancer detection
Rates of positive DELFI tests, CT completion, and diagnosed lung cancers will be estimated with binomial proportion and exact Clopper-Pearson 95% confidence intervals. Associations between DELFI test positivity and demographic factors will be assessed univariably with non-parametric Wilcoxon rank-sum tests for quantitative factors and Fisher's exact tests for qualitative factors.
Time frame
After completing data collection upon study completion, three yearsSponsors and contacts
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Source ClinicalTrials.gov