Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer

Overview

The purpose of this study is to determine whether availability of a DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test to practicing physicians affects overall lung cancer screening rates among their patients who are recommended and eligible for screening based on 2021 United States Preventive Services Task Force (USPSTF) but are not up to date with it. DELFI hypothesized that patients in the care of physicians or practice groups who have the DELFI Lung Cancer Screening Test will have increased lung screening rates compared to patients in the care of physicians or practice groups who do not have access to the DELFI Lung Cancer Screening Test.

Description

Despite compelling evidence of the benefits of lung cancer screening, rates among eligible individuals in the United States remain stubbornly low. Using a cluster randomized controlled trial, DELFI plans to evaluate whether lung screening rates can be increased if physicians and practice groups have the ability to order a validated, commercially available DELFI Lung Cancer Screening Test as an initial test for eligible individuals who are not up to date with lung screening recommendations.

Eligibility

Inclusion Criteria:

1. Practice offers primary care services. Primary care services may include, but are not limited to: community health centers, academic outpatient facilities, private practices of family or general internal medicine, and Veterans Administration outpatient primary care clinics.
2. Practice has a lung cancer screening population of a minimum of 50 individuals. a. Lung cancer screening eligible population is defined as meeting the 2021 USPSTF guideline recommendations (current and former smokers 50-80 years of age, 20 pack-year or more smoking history, have not quit more than 15 years ago) b. Individuals have had a clinic visit in the past 12 months, and c. Individuals have not had a CT for lung cancer screening in the last 15 months.
3. Practice can complete EMR data extraction and EDC entry during the study.
4. Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
5. Practice can identify a central phlebotomy site.

Exclusion Criteria:

1. Practice is currently participating or has previously participated in other DELFI studies.
2. Practice actively participates in any other early cancer detection biomarker studies.