Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier

What this Trial Is About

Researchers are evaluating how doctors use the Percepta4 Nasal Swab test results to manage patients with newly found pulmonary nodules. This observational study aims to see if the test helps reduce invasive procedures in patients with low-risk benign nodules and speeds up treatment for those with high-risk cancerous nodules. The study is prospective, multicenter, and randomized, involving patients whose nodules were found incidentally or through lung cancer screening. Participants will be randomly assigned to two groups: one where the Percepta Nasal Swab test result is given to the physician and one where it is not. The study will compare how doctors manage patients' nodules with and without access to the test result. About 2400 participants will be enrolled across up to 100 US centers, with enrollment lasting around 24 months. Follow-up will continue for 24 to 30 months or until a lung cancer diagnosis. During the study, researchers will track the number of invasive diagnostic procedures from randomization until the nodule is confirmed benign or stable for up to 30 months. They will also measure the time from randomization to the start of lung cancer treatment. Participants will undergo nasal specimen collection, and clinical history and imaging data will be reviewed. The study observes routine care decisions influenced by the test, without altering standard treatment plans.

Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier