Evaluating a new lung cancer screening test to improve screening rates
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
This study tests if giving doctors access to a new lung cancer screening test can help more eligible patients get screened for lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Delfi Diagnostics Inc. Industry-sponsored |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06145750 on ClinicalTrials.gov |
What this trial studies
This study aims to assess whether providing physicians with access to the FirstLook™ lung cancer screening test can increase screening rates among eligible patients who are currently not up to date with recommended screenings. It employs a cluster randomized controlled trial design, comparing practices that can order the FirstLook™ test to those that cannot. The study targets primary care practices with a significant lung cancer screening population and evaluates the impact of this intervention on overall screening rates.
Who should consider this trial
Good fit: Ideal candidates for this study are primary care practices with a lung cancer screening population that meets specific eligibility criteria outlined by the USPSTF.
Not a fit: Patients who do not meet the eligibility criteria for lung cancer screening, such as those outside the specified age range or smoking history, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase lung cancer screening rates, leading to earlier diagnosis and improved patient outcomes.
How similar studies have performed: Other studies have shown that targeted interventions can improve screening rates, suggesting that this approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Vuong
- Email: L301@delfidiagnostics.com
- Phone: (800) 589-2182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.