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

Lung Cancer Clinical Trial

— FIRSTLungL301  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145750
• Other study ID #: DELFI-L301
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Delfi Diagnostics Inc.
• Contact: Carolina Sheridan
• Phone: (800) 589-2182
• Email: L301[@]delfidiagnostics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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. 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. Practice can identify a central phlebotomy site.

Exclusion Criteria:

1. Practice is currently participating or has previously participated in other DELFI studies.

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Ability to order FirstLook™
FirstLook™ 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. FirstLook™ 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). FirstLook™ 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:
• Continuing Medical Education for Lung Cancer
Physician practice will receive standard education on lung cancer screening for CME credit.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Delfi Diagnostics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Estimate the number NNS with FirstLook™ to detect one additional lung cancer during the study period.		15 months

External Links

•   Detection and characterization of lung cancer using cell-free DNA fragmentomes
•   Genome-wide cell-free DNA fragmentation in patients with cancer
•   Screening for Lung Cancer US Preventive Services Task Force Recommendation Statement
•   Screening for Lung Cancer: CHEST Guideline and Expert Panel Report