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

Not Applicable

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06145750
• Lead Sponsor: Delfi Diagnostics Inc.

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 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™.

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 FirstLook™ as an initial test for eligible individuals who are not up to date with lung screening recommendations.

Study Timeline

• Study Start: 2023-10-31
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. 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.
2. 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.
3. Practice can complete EMR data extraction and EDC entry during the study.
4. Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
5. The practice utilizes conveniently located phlebotomy that accepts same-day services.

Exclusion Criteria

1. Practice is currently participating in other DELFI studies.
2. Practice is actively participating in any other cancer screening blood-based biomarker studies which includes return of results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Estimate the number NNS with FirstLook™ to detect one additional lung cancer during the study period.	15 months
Proportion of practice-identified screen-eligible individuals receiving a CT order and scan for lung cancer screening following FirstLook™ test result during the study period.	15 months

Trial Locations

Locations (3)

DARTNet Institute; 🇺🇸 Aurora, Colorado, United States

University Of Florida; 🇺🇸 Jacksonville, Florida, United States

Duke University; 🇺🇸 Durham, North Carolina, United States