IRB Study Number 23-673
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
To evaluate if use of the Percepta Nasal Swab test in the diagnostic work up of newly identified pulmonary nodules reduces the number of invasive procedures in the group classified as low-risk by the test and that are benign as compared to a control group managed without a Percepta Nasal Swab test result.
Inclusion Criteria
• Able to tolerate nasal epithelial specimen collection
• Signed written Informed Consent obtained
• Subject clinical history available for review by sponsor and regulatory agencies
• New nodule first identified on imaging < 90 days prior to nasal sample collection
(index nodule)
• CT report available for index nodule
• 29 - 85 years of age
• Current or former smoker (>100 cigarettes in a lifetime)
• Pulmonary nodule ≤30 mm detected by CT
Exclusion Criteria
• Subject has undergone a diagnostic procedure for the management of their
index nodule after the index CT and prior to enrollment
• Active cancer (other than non-melanoma skin cancer)
• Prior primary lung cancer (prior non-lung cancer acceptable)
• Prior participation in this study (i.e., subjects may not be enrolled more than
once)
• Current active treatment with an investigational device or drug (patients in trial
follow up period are okay if intervention phase is complete)
• Patient enrolled or planned to be enrolled in another clinical trial that may
influence management of the patient’s nodule
• Concurrent or planned use of tools or tests for assigning lung nodule risk of
malignancy (e.g., genomic or proteomic blood tests) other than clinically
validated risk calculators
