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NCT06145750 | RECRUITING | Lung Cancer

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

Delfi Diagnostics Inc.

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™.

Condition or disease

Lung Cancer

Intervention/treatment

Ability to order FirstLook™

Continuing Medical Education for Lung Cancer

Phase

NA

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
Estimated Enrollment : 90 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
Actual Study Start Date : 2023-10-31
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer

Location Details

NCT06145750

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Dartnet Institute

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

University Of Florida

Jacksonville, Florida, United States, 32209

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27705