CHAMP Lung Cancer Screening Program

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Jill Kolesar
Study ID
NCT07572773
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 77 Years
Healthy Volunteers
Not accepted

Interventions

  • DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test — DIAGNOSTIC_TEST
    A 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_TEST
    If 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.

Primary Outcome Measure

Proportion of pharmacy patrons receiving lung cancer screening [ Time Frame: From enrollment through six months after enrollment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Laura Seegmiller
[email protected]
(319) 384-1494
Jill Kolesar, PharmD, MS, FCCP (PRINCIPAL_INVESTIGATOR)
Cedar Valley Primary Care & Walk-In ClinicWaterlooIowa50701
Sarah Larson, BSN, RN
[email protected]
319-888-8270
James Hoehns, PharmD, BCPS, FCCP (SUB_INVESTIGATOR)
Greenwood Pharmacy and Compounding CenterWaterlooIowa50702
Robert Nichols, PharmD, BCPS

Find similar trials in Iowa City, IA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Iowa· Iowa City, IACedar Valley Primary Care & Walk-In Clinic· Waterloo, IAGreenwood Pharmacy and Compounding Center· Waterloo, IA

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