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Trial Title:
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
NCT ID:
NCT06145750
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: 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
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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. The study will be
conducted under a waiver of consent as it is embedded into standard care, and the risk to
patients is considered minimal.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Ability to order FirstLook™
Description:
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 or older who either currently or previously smoked cigarettes and accumulated 20
pack-years or more of exposure.
Arm group label:
Arm B
Other name:
FirstLook™
Intervention type:
Other
Intervention name:
Continuing Medical Education for Lung Cancer
Description:
Physician practice will receive standard education on lung cancer screening for CME
credit.
Arm group label:
Arm A2
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™.
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.
Criteria for eligibility:
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. 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. Practice can identify a central phlebotomy site.
Exclusion Criteria:
1. Practice is currently participating or has previously participated in other DELFI
studies.
2. Practice is participating in any other cancer screening blood-based biomarker
studies which includes return of results.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Start date:
October 31, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Delfi Diagnostics Inc.
Agency class:
Industry
Source:
Delfi Diagnostics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06145750
https://www.nature.com/articles/s41467-021-24994-w
https://pubmed.ncbi.nlm.nih.gov/34270968/
https://www.nature.com/articles/s41586-019-1272-6
https://jamanetwork.com/journals/jama/fullarticle/2777244
