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CHAMP: Community Health Assessment and Monitoring in the Pharmacy. Assessing the Impact of a Community Pharmacist Lung Cancer Screening (LCS) Program

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 77
Healthy Volunteers: f
View:

• 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

Locations
United States
Iowa
University of Iowa
RECRUITING
Iowa City
Cedar Valley Primary Care & Walk-In Clinic
RECRUITING
Waterloo
Greenwood Pharmacy and Compounding Center
RECRUITING
Waterloo
Contact Information
Primary
Laura Seegmiller
champ-study@uiowa.edu
(319) 384-1494
Time Frame
Start Date: 2026-06-12
Estimated Completion Date: 2028-06
Participants
Target number of participants: 300
Treatments
Experimental: DELFI FirstLook Lung Cancer Screening Blood Test
Participants may choose to receive the DELFI Diagnostics FirstLook Lung test, a blood-based screening test designed to support early detection of lung cancer. The test analyzes patterns in cell-free DNA fragments using whole-genome sequencing and machine-learning techniques. Designed to augment traditional low-dose CT screening, it offers a minimally invasive and accessible option for early lung cancer detection.~If a participant elects to receive this test, a blood sample will be collected at a study clinic and sent to a DELFI Diagnostics lab without any personal identifying health information attached. After processing, results are returned to the study team. Participants will be notified if results are not elevated, in which case repeating the test in one year is recommended. If results are elevated, study staff will recommend follow-up screening with a low-dose CT scan from local clinic for further evaluation.~Both the blood test and CT will be provided by the study at no cost.
Active_comparator: Low-Dose CT
Participants can choose to follow current US Preventive Services Task Force recommendations of a low-dose CT scan ordered through their primary care physician.
No_intervention: No lung cancer screening
Participants chose to not participate in lung cancer screening. Annually, participants will be informed about lung cancer screening options and given the opportunity to participate in one of the screening options. Participants will have the ability to change their mind and choose one of the lung cancer screening options in between their annual screening discussion.
Related Therapeutic Areas
Sponsors
Leads: Jill Kolesar
Collaborators: Eli Lilly and Company

This content was sourced from clinicaltrials.gov