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

NCT06145750 | Completed

• 1 other identifier: DELFI-L301
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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™.

Conditions

Lung Cancer

Keywords

Lung Cancer Screening; Early Diagnosis; Low Dose CT Scan; CT Scan; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Biomarkers; Lung Cancer Prevention; Fragmentomics; CAT Scan; Early Detection; NSCLC; Adenocarcinoma; Lung Malignancy; Liquid Biopsy; LDCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Arm A1

NO INTERVENTION

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

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

Arm B

EXPERIMENTAL

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™

Interventions

Ability to order FirstLook™ DIAGNOSTIC_TEST

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.

Also known as: FirstLook™

Arm B

Continuing Medical Education for Lung Cancer OTHER

Physician practice will receive standard education on lung cancer screening for CME credit.

Arm A2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Delfi Diagnostics Inc.: lead

Study Sites (3)

DARTNet Institute

Aurora, Colorado, 80045, United States

Location

University Of Florida

Jacksonville, Florida, 32209, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related 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

MeSH Terms

Conditions

Lung Neoplasms; Disease; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Peter Bach, MD

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Physician practices (the study participants) will be randomized 1:1:2 to Arm A1 (control), Arm A2 (Control) or Arm B (intervention). 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; practices in A2 will receive standard education on lung cancer screening for Continuing Medical Education (CME) credit. Randomizing within Arm A aims to delineate the impact standard lung cancer screening education may have on utilization. Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion. A limited data set (LDS) will be extracted from the primary care practice EMRs for the study analysis.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: October 31, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)