Status:
COMPLETED
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
Lead Sponsor:
Delfi Diagnostics Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ove...
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 pl...
Eligibility Criteria
Inclusion
- 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 upon first review of patient records. 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.
- The practice utilizes conveniently located phlebotomy that accepts same-day services.
Exclusion
- Practice is currently participating in other DELFI studies.
- Practice is actively participating in any other cancer screening blood-based biomarker studies which includes return of results.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06145750
Start Date
October 31 2023
End Date
August 31 2025
Last Update
November 24 2025
Active Locations (3)
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1
DARTNet Institute
Aurora, Colorado, United States, 80045
2
University Of Florida
Jacksonville, Florida, United States, 32209
3
Duke University
Durham, North Carolina, United States, 27705