Clinical trial NCT06145750: Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
Official title: Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Delfi Diagnostics Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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™.

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.

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.

Primary outcomes:
measure: Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT order and scan during the study period in each arm.
timeFrame: 15 months
Secondary outcomes:
measure: Proportion of practice-identified screen-eligible individuals receiving a CT order and scan for lung cancer screening following FirstLook™ test result during the study period.
timeFrame: 15 months
measure: Estimate the number NNS with FirstLook™ to detect one additional lung cancer during the study period.
timeFrame: 15 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Director, Medical Affairs
name: Lindsey Cotton, D.O.Med.
role: STUDY_CHAIR
References: