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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1 | No Intervention | Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A1 will be observed. | |
| Arm A2 | Active Comparator | Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A2 will receive standard education on lung cancer screening for CME credit. |
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| Arm B | Experimental | Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ability to order FirstLook™ | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT scan during the study period in each arm. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bach, MD | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DARTNet Institute | Aurora | Colorado | 80045 | United States | ||
| University Of Florida |
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| Label | URL |
|---|---|
| Detection and characterization of lung cancer using cell-free DNA fragmentomes | View source |
| Screening for Lung Cancer: CHEST Guideline and Expert Panel Report | View source |
| Genome-wide cell-free DNA fragmentation in patients with cancer |
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Physician practices (the study participants) will be randomized 1:1:2 to Arm A1 (control), Arm A2 (Control) or Arm B (intervention). Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A1 will be observed; practices in A2 will receive standard education on lung cancer screening for Continuing Medical Education (CME) credit. Randomizing within Arm A aims to delineate the impact standard lung cancer screening education may have on utilization. Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion. A limited data set (LDS) will be extracted from the primary care practice EMRs for the study analysis.
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| Continuing Medical Education for Lung Cancer | Other | Physician practice will receive standard education on lung cancer screening for CME credit. |
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| 15 months |
| Number needed to screen (NNS) with FirstLook™ to detect one additional lung cancer during the study period. | 15 months |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| View source |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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