FIRSTLungL301: Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Arm A1 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. |
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| Active Comparator: Arm A2 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
Physician practice will receive standard education on lung cancer screening for CME credit.
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| Experimental: Arm B 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
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.
Other Names:
Other: Continuing Medical Education for Lung Cancer
Physician practice will receive standard education on lung cancer screening for CME credit.
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
Other Outcome Measures
- Proportion of SDM visits completed by the provider and subsequent confirmation of completed LDCT in the control arm versus the proportion of completed SDM visits with an ordered and completed LDCT in the intervention arm. [15 months]
Only LDCTs with shared decision-making as required by Centers for Medicare and Medicaid Services (CMS) will be evaluated.
- Proportion of CTs for lung cancer screening completed within the follow-up window compared to the proportion of screening CTs ordered prior to day 0. [15 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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.
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Practice can complete EMR data extraction and EDC entry during the study.
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Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
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Practice can identify a central phlebotomy site.
Exclusion Criteria:
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Practice is currently participating or has previously participated in other DELFI studies.
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Practice actively participates in any other early cancer detection biomarker studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Delfi Diagnostics Inc.
Investigators
- Study Chair: Peter Bach, MD, Chief Medical Officer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Detection and characterization of lung cancer using cell-free DNA fragmentomes
- Screening for Lung Cancer: CHEST Guideline and Expert Panel Report
- Genome-wide cell-free DNA fragmentation in patients with cancer
- Screening for Lung Cancer US Preventive Services Task Force Recommendation Statement
Publications
None provided.- DELFI-L301