CHAMP Lung Cancer Screening Program

NCT07572773 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 202512332
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lung Cancer; Early Lung Cancer Detection

Keywords

lung cancer; early lung cancer detection; lung cancer screening; community pharmacy intervention; pharmacy cancer screening

Outcome Measures

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.

  From enrollment through six months after enrollment

Secondary Outcomes (4)

• Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test

  From enrollment through six months after enrollment

• Determine the proportion of eligible participants that receive a low-dose CT scan

  From enrollment through six months after enrollment

• Correlations between demographic data and declining of initial screening

  From time of enrollment through 30 days after enrollment

• Frequency of individuals who complete screening in year 1 that return for screening in year 2

  From 12 through 18 months after initial enrollment

Other Outcomes (5)

• Rate of positive DELFI Diagnostics FirstLook lung cancer screening tests

  From enrollment through 12 months after enrollment

• Diagnostic CT completion rate among participants with a positive DELFI Diagnostics FirstLook lung cancer screening test

  From time of positive DELFI test through 12 months after test results

• Percentage of participants diagnosed with lung cancer

  From time of CT scan until completion of study, up to three years

Study Arms (3)

DELFI FirstLook Lung Cancer Screening Blood Test

EXPERIMENTAL

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.

Diagnostic Test: DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test

Low-Dose CT

ACTIVE COMPARATOR

Participants can choose to follow current US Preventive Services Task Force recommendations of a low-dose CT scan ordered through their primary care physician.

Diagnostic Test: Low-Does CT Scan

No lung cancer screening

NO INTERVENTION

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.

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.

DELFI FirstLook Lung Cancer Screening Blood Test

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.

Low-Dose CT

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jill Kolesar: lead
• Eli Lilly and Company: collaborator

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Cedar Valley Primary Care & Walk-In Clinic

Waterloo, Iowa, 50701, United States

Location

Greenwood Pharmacy and Compounding Center

Waterloo, Iowa, 50702, United States

Location

Related Publications (6)

• 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. Jul 2023;38(Suppl 3):916-922. doi:10.1007/s11606-023-08122-6

  BACKGROUND

• Ali N, Lifford KJ, Carter B, et al. 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. Jul 14 2015;5(7):e008254. doi:10.1136/bmjopen-2015-008254

  BACKGROUND

• 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. Dec 2024;43(4):1217-1231. doi:10.1007/s10555-024-10187-6

  BACKGROUND

• Characteristics of Persons Screened for Lung Cancer in the United States. Annals of Internal Medicine. 2022;175(11):1501-1505. doi:10.7326/m22-1325 %m 36215712

  BACKGROUND

• Lin Y, Tabatabaei SMH, Ding R, et al. 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. Nov 1 2025;40(6)doi:10.1097/rti.0000000000000838

  BACKGROUND

• Force UPST. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(10):962-970. doi:10.1001/jama.2021.1117

  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jill Kolesar, PharmD, MS, FCCP

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Seegmiller

CONTACT

(319) 384-1494; champ-study@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)