This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules.
The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.
