The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ 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 FirstLook™ will have increased lung screening rates compared to patients in the care of physicians or practice groups who do not have access to FirstLook™.
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 FirstLook™ as an initial test for eligible individuals who are not up to date with lung screening recommendations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
28
FirstLook™ is a commercially available, validated next generation sequencing assay of plasma cell-free DNA (cfDNA) that analyzes the distribution of cfDNA fragment sizes to indicate the presence of possible lung cancer. FirstLook™ is intended to be used by a qualified healthcare provider and is not a replacement for computed tomography (CT) or low-dose computed tomography (LDCT). FirstLook™ is validated for use in individuals aged 50 to 80 who either currently or previously smoked cigarettes and accumulated 20 pack-years or more of exposure.
Physician practice will receive standard education on lung cancer screening for CME credit.
DARTNet Institute
Aurora, Colorado, United States
University Of Florida
Jacksonville, Florida, United States
Duke University
Durham, North Carolina, United States
Proportion of practice-identified lung cancer screen-eligible individuals receiving any screening event, defined as either a screening CT (LDCT or chest CT) or FirstLook™ Lung test (FLL) blood draw during the study period in each arm.
Time frame: 15 months
Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT scan during the study period in each arm.
Time frame: 15 months
Proportion of practice-identified lung cancer screen-eligible individuals receiving a CT order and/or completed CT scan for lung cancer screening following FirstLook™ test result during the study period.
Time frame: 15 months
Number needed to screen (NNS) with FirstLook™ to detect one additional lung cancer during the study period.
Time frame: 15 months
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