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OpenTrials
Completed

NCT Number: NCT06145750

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

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™.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DARTNet Institute, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: FirstLook™

Continuing Medical Education for Lung Cancer

Other

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

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.

    Time frame: 15 months

Secondary outcomes

  1. Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT scan during the study period in each arm.

    Time frame: 15 months

  2. 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.

    Time frame: 15 months

  3. Number needed to screen (NNS) with FirstLook™ to detect one additional lung cancer during the study period.

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Delfi Diagnostics Inc.

Industry

Registry information

Acronym: FIRSTLUNG

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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