Recruiting

Lung Cancer Screening

Sponsor:

Jill Kolesar

Code:

NCT07572773

Conditions

Lung Cancer

Early Lung Cancer Detection

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test

Low-Does CT Scan

Study Details

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

Study ID

NCT07572773

Start date

Jun 12, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

DELFI Diagnostics FirstLook Lung Cancer Screening Blood 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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Laura Seegmiller

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

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Laura Seegmiller

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

Principal Investigator:

Jill Kolesar, PharmD, MS, FCCP

Cedar Valley Primary Care & Walk-In Clinic

Recruiting

Waterloo, Iowa, United States, 50701

Contacts

Sarah Larson, BSN, RN

319-888-8270slarson@cvmspc.com

Greenwood Pharmacy and Compounding Center

Recruiting

Waterloo, Iowa, United States, 50702

More Information

Sponsor

Jill Kolesar

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jill Kolesar on 2026-06-16.