NCT06538636 Prediction Augmented Screening Initiative
| NCT ID | NCT06538636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 23,520 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-03-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23,520 participants in total. It began in 2026-06-01 with a primary completion date of 2029-03-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lung cancer is responsible for more deaths in the United States than breast, prostate and colon cancer combined and is the number one cancer killer of Veterans. This is because lung cancer is usually diagnosed when the disease has spread, and cure is less likely. Lung cancer screening (LCS) finds cancer at an earlier stage when it is curable, yet only 20% of eligible Veterans have been screened. Uptake is even lower among Black Veterans despite higher lung cancer risk. Using prediction models to identify high-benefit people for whom LCS should be encouraged improves efficiency and reduces disparities. Moreover, it is more patient-centered as shared decision-making conversations can be tailored with personalized information. The US Preventive Services Task Force has called for research to demonstrate that prediction-augmented LCS can be feasibly implemented at the point-of-care. The investigators propose for VA to lead this effort with a large-scale pragmatic clinical trial to show that prediction-augmented LCS is both feasible and improves LCS uptake.
Eligibility Criteria
Inclusion Criteria: Veterans assigned a PCP at a participating site and who meet inclusion criteria at any point during the study timeframe will be enrolled into the trial. There will be two paths to patient inclusion: * meeting USPSTF eligibility criteria for LCS, as currently encoded in the background logic of LCS clinical reminders maintained by the VA National Center for Lung Cancer Screening (i.e., age 50-80 years; smoked 20 pack-years; current smoking or quit \<15 years ago) OR * predicted benefit calculated using LYFS-CTVA model exceeds a stringent high-benefit threshold of life-year gains with annual LCS, as recommended in the 2021 CHEST LCS guidelines Exclusion Criteria: * Veterans who have previously undergone lung cancer screening, are diagnosed with lung cancer, or who do not meet eligibility criteria outlined above
Contact & Investigator
Nichole T Tanner, MD MS BS
PRINCIPAL INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Frequently Asked Questions
Who can join the NCT06538636 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06538636 currently recruiting?
Yes, NCT06538636 is actively recruiting participants. Contact the research team at Nichole.Tanner@va.gov for enrollment information.
Where is the NCT06538636 trial being conducted?
This trial is being conducted at Bedford, United States, Boston, United States, Ann Arbor, United States, Charleston, United States.
Who is sponsoring the NCT06538636 clinical trial?
NCT06538636 is sponsored by VA Office of Research and Development. The principal investigator is Nichole T Tanner, MD MS BS at Ralph H. Johnson VA Medical Center, Charleston, SC. The trial plans to enroll 23,520 participants.
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