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Lung CancerCHAMPNCT07572773

CHAMP Lung Cancer Screening Program

A study testing DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test and Low-Does CT Scan in people with Lung Cancer and Early Lung Cancer Detection, run by Jill Kolesar at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 77 years
Conditions the study is for
Lung Cancer, Early Lung Cancer Detection
What is being tested?
DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test and Low-Does CT Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesUnited States
Study dates
12 Jun 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • self-report of lung cancer screening in the last 12 months
  • psychiatric illness/social situations that would limit compliance with study requirements

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Seegmiller contact

(319) 384-1494

champ-study@uiowa.edu

United States3 sites, 3 recruiting
  • University of Iowa

    Iowa City, Iowa, 52242

    Laura Seegmiller, (319) 384-1494, champ-study@uiowa.edu

    Jill Kolesar, PharmD, MS, FCCP

    Recruiting
  • Cedar Valley Primary Care & Walk-In Clinic

    Waterloo, Iowa, 50701

    Sarah Larson, BSN, RN, 319-888-8270, slarson@cvmspc.com

    James Hoehns, PharmD, BCPS, FCCP

    Recruiting
  • Greenwood Pharmacy and Compounding Center

    Waterloo, Iowa, 50702

    Robert Nichols, PharmD, BCPS

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low dose Computerized Tomography (CT) scans for adults aged 50-80 with a 20-pack year smoking history who are current smokers or who have quit within the last 15 years. Despite these recommendations and Medicaid/Medicare coverage, only about 17% of eligible patients were screened in Iowa in 2024. Barriers to implementing LCS are multifactorial and include patient and clinician barriers, specifically complexity of screening and primary care physician competing demands. To overcome these barriers, investigators propose a two-part intervention: first, a blood test, that reduces the complexity of lung cancer screening and second, a community pharmacist referral program that can be performed as part of routine care received in the pharmacy.

LCS eligible participants will be identified in Greenwood Pharmacy in Waterloo, Iowa and invited to participate in a lung cancer screening study. If they are interested, the pharmacist will review the consent form with them, explaining the study and answering any questions they have. After the consent is signed, the participant will engage in a shared decision-making conversation about LCS with the pharmacist. As part of this conversation, patients will be told they are eligible for LCS and given three options: Decline to participate; agree to participate and get DELFI blood test; or agree to participate but decline blood test and pursue a CT scan with their PCP. Patients agreeable to the blood test will be referred to Cedar Valley Family Medicine, where they can receive the DELFI FirstLook Lung Cancer Screening Test. Those with a positive (elevated) blood test will have a standard of care clinic appointment with the primary care physician at Cedar Valley Family Medicine for a shared decision-making visit about LCS and if warranted, order confirmatory CT scanning which is standard of care and billed to the study. Patients with a negative blood test will be added to the "Screening Cohort" and approached annually for a total of 2 years to participate in screening.

Being tested
DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test, Low-Does CT Scan
Keywords
lung cancer, early lung cancer detection, lung cancer screening, community pharmacy intervention, pharmacy cancer screening
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DELFI Diagnostics FirstLook Lung Cancer Screening Blood TestDiagnostic 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 ScanDiagnostic 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 groups in NCT07572773
Study groupRoleWhat they receive
DELFI FirstLook Lung Cancer Screening Blood TestExperimentalParticipants 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.
Receives: Diagnostic Test: DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test
Low-Dose CTActive comparatorParticipants can choose to follow current US Preventive Services Task Force recommendations of a low-dose CT scan ordered through their primary care physician.
Receives: Diagnostic Test: Low-Does CT Scan
No lung cancer screeningNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment through six months after enrollment

Secondary outcomes (4)
  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.

    Measured: From enrollment through six months after enrollment

  2. 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.

    Measured: From enrollment through six months after enrollment

  3. 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.

    Measured: From time of enrollment through 30 days after enrollment

  4. 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.

    Measured: From 12 through 18 months after initial enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start12 Jun 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07572773
Sponsor's protocol ID
202512332
Acronym
CHAMP
Status last verified
Jun 2026
First submitted
23 Apr 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Arredondo K, Touchett HN, Khan S, Vincenti M, Watts BV. Current Programs and Incentives to Overcome Rural Physician Shortages in the United States: A Narrative Review. J Gen Intern Med. 2023 Jul;38(Suppl 3):916-922. doi: 10.1007/s11606-023-08122-6. Epub 2023 Jun 20.

    PubMed 37340266
  • Ali N, Lifford KJ, Carter B, McRonald F, Yadegarfar G, Baldwin DR, Weller D, Hansell DM, Duffy SW, Field JK, Brain K. Barriers to uptake among high-risk individuals declining participation in lung cancer screening: a mixed methods analysis of the UK Lung Cancer Screening (UKLS) trial. BMJ Open. 2015 Jul 14;5(7):e008254. doi: 10.1136/bmjopen-2015-008254.

    PubMed 26173719
  • Kurzrock R, Chaudhuri AA, Feller-Kopman D, Florez N, Gorden J, Wistuba II. Healthcare disparities, screening, and molecular testing in the changing landscape of non-small cell lung cancer in the United States: a review. Cancer Metastasis Rev. 2024 Dec;43(4):1217-1231. doi: 10.1007/s10555-024-10187-6. Epub 2024 May 16.

    PubMed 38750337
  • Silvestri GA, Goldman L, Burleson J, Gould M, Kazerooni EA, Mazzone PJ, Rivera MP, Doria-Rose VP, Rosenthal LS, Simanowith M, Smith RA, Tanner NT, Fedewa S. Characteristics of Persons Screened for Lung Cancer in the United States : A Cohort Study. Ann Intern Med. 2022 Nov;175(11):1501-1505. doi: 10.7326/M22-1325. Epub 2022 Oct 11.

    PubMed 36215712
  • Lin Y, Tabatabaei SMH, Ding R, Sanders TA, Aberle DR, Hsu W, Prosper AE. Analyzing Patient Characteristics and Lung Cancer Outcomes Pre and Post the 2021 USPSTF Lung Cancer Screening Guidelines: Experience From a Large Academic Institution. J Thorac Imaging. 2025 Nov 1;40(6):e0838. doi: 10.1097/RTI.0000000000000838.

    PubMed 40685891
  • US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117.

    PubMed 33687470

Questions about this trial

What is this clinical trial studying?

A study testing DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test and Low-Does CT Scan in people with Lung Cancer and Early Lung Cancer Detection, run by Jill Kolesar at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Seegmiller ((319) 384-1494, champ-study@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of pharmacy patrons receiving lung cancer screening (time frame: From enrollment through six months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07572773, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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