Overview
The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule.
The main questions it aims to answer are:
- Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign?
- Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer?
Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups.
Description
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.
Eligibility
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 identified on imaging < 90 days prior to nasal sample collection
- 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:
- 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
- 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 other than clinically validated risk calculators