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

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™.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Continuing Medical Education for Lung Cancer; Diagnostic test: Ability to order 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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • DARTNet Institute
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm A1; 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.
Active Comparator: Arm A2; 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.	Other: Continuing Medical Education for Lung Cancer; Physician practice will receive standard education on lung cancer screening for CME credit.
Experimental: Arm B; Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion;	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 to 80 who either currently or previously smoked cigarettes and accumulated 20 pack-years or more of exposure.; Other Names: FirstLook™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of practice-identified lung cancer screen-eligible individuals receiving any screening event, defined as either a screening CT (LDCT or chest CT) or FirstLook™ Lung test (FLL) blood draw during the study period in each arm.	15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT scan during the study period in each arm.	15 months
Proportion of practice-identified lung cancer screen-eligible individuals receiving a CT order and/or completed CT scan for lung cancer screening following FirstLook™ test result during the study period.	15 months
Number needed to screen (NNS) with FirstLook™ to detect one additional lung cancer during the study period.	15 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of SDM visits completed by the provider and subsequent confirmation of completed LDCT in the control arm versus the proportion of completed SDM visits with an ordered and completed LDCT in the intervention arm.	Only LDCTs with shared decision-making as required by Centers for Medicare and Medicaid Services (CMS) will be evaluated.	15 months
Proportion of CTs for lung cancer screening completed within the follow-up window compared to the proportion of screening CTs ordered prior to day 0.		15 months

Collaborators and Investigators

• Sponsor: Delfi Diagnostics Inc.
• Investigators: Study Chair: Peter Bach, MD, Chief Medical Officer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; NSCLC; Adenocarcinoma; Biomarkers; Lung Diseases; Liquid Biopsy; Thoracic Neoplasms; Early Detection; Early Diagnosis; Lung Neoplasms; LDCT; Lung Cancer Screening; CT Scan; Respiratory Tract Neoplasms; Low Dose CT Scan; Lung Cancer Prevention; Fragmentomics; CAT Scan; Lung Malignancy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Pathological Conditions, Signs and Symptoms; Lung Diseases; Lung Neoplasms; Disease; Adenocarcinoma; Respiratory Tract Diseases; Thoracic Neoplasms; Respiratory Tract Neoplasms
• Other Study ID Numbers: DELFI-L301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No