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

NCT06145750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

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

Continuing Medical Education for Lung Cancer

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

Sponsors & Collaborators

  • Delfi Diagnostics Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Bach, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06145750 on ClinicalTrials.gov