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

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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™.

Key facts

Study ID

NCT06145750

Run by

Delfi Diagnostics Inc.

People needed

28

Starts

2023-10-31

Expected to finish

2025-08-31

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• DARTNet Institute — Aurora, Colorado, United States
• University Of Florida — Jacksonville, Florida, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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