Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer (FIRSTLungL301)

Delfi Diagnostics

Status: Enrolling

Conditions: Lung Cancer

Treatments: Diagnostic Test: Ability to order FirstLook™; Other: Continuing Medical Education for Lung Cancer

Study type: Interventional

Funder types: Industry

Identifiers

NCT06145750

DELFI-L301

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Arm A1

No Intervention group

Description:

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.

Arm A2

Active Comparator group

Description:

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A2 will receive standard education on lung cancer screening for CME credit.

Treatment:

Other: Continuing Medical Education for Lung Cancer

Arm B

Experimental group

Description:

Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion;

Treatment:

Diagnostic Test: Ability to order FirstLook™