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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating the Clinical Utility of DELFI Evaluation of Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Ability to order DELFI lung cancer screening test
* Other: Continuing Medical Education for Lung Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Practice can complete EMR data extraction and EDC entry during the study. Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT. Practice can identify a central phlebotomy site. Exclusion Criteria: Practice is currently participating or has previously participated in other DELFI studies. Practice actively participates in any other early cancer detection biomarker studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Physician practices (the study participants) will be randomized 1:1 to Arm A (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. Arm B (intervention) practices will receive education on DELFI Lung Cancer Screening Test and have access to order DELFI Lung Cancer Screening Test at the providers' discretion; in addition to receiving education on lung cancer screening for CME credit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A1<br>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. | |
| Active Comparator: Arm A2<br>Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. A2 will receive standard education on lung cancer screening for CME credit. | Other: Continuing Medical Education for Lung Cancer<br>* Physician practice will receive standard education on lung cancer screening for CME credit.<br>|
| Experimental: Arm B<br>Arm B (intervention) practices will receive education on DELFI Lung Cancer Screening Test and have access to order DELFI Lung Cancer Screening Test at the providers' discretion; in addition to receiving education on lung cancer screening for CME credit. | Diagnostic Test: Ability to order DELFI lung cancer screening test<br>* The DELFI Lung Cancer Screening Test 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. DELFI Lung Cancer Screening Test 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). DELFI Lung Cancer Screening Test is validated for use in individuals aged 50 or older who either currently or previously smoked cigarettes and accumulated 20 pack-years or more of exposure.<br>* Other names: DELFI Lung Cancer Screening Test;Other: Continuing Medical Education for Lung Cancer<br>* Physician practice will receive standard education on lung cancer screening for CME credit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT order and scan during the study period in each arm. |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of practice-identified screen-eligible individuals receiving a CT order and scan for lung cancer screening following DELFI Lung Cancer Screening Test result during the study period. |  | 15 months | 
| Estimate the number NNS with DELFI Lung Cancer Screening Test to detect one additional lung cancer during the study period. |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT Scan, Lung Neoplasms, Lung Diseases, Lung Cancer Screening, Early Diagnosis, Low Dose CT Scan, Respiratory Tract Neoplasms, Thoracic Neoplasms, Respiratory Tract Diseases, Biomarkers, Lung Cancer Prevention, Fragmentomics, CAT Scan, Early Detection, NSCLC, Adenocarcinoma, Lung Malignancy, Liquid Biopsy, LDCT