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

Launched by VERACYTE, INC. · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a special test called the Percepta® Nasal Swab can help doctors manage patients with newly found lung nodules, which are small growths in the lungs that can sometimes indicate cancer. The trial aims to find out if using this test can help avoid unnecessary invasive procedures for people with low-risk results (indicating the nodule is likely benign) and whether it can speed up treatment for those with high-risk results (indicating the nodule might be cancerous). Participants will be randomly placed into two groups: one group will have their test results shared with their doctor, while the other will not, allowing researchers to compare how the two groups are treated.

To be eligible for this trial, participants should be between 29 to 85 years old, current or former smokers, and have a new lung nodule identified within the last 90 days. They should also be able to tolerate a nasal swab sample collection. Participants will be asked to provide informed consent and have their medical history reviewed. It’s important to note that individuals with active cancer (except for certain skin cancers) or those currently undergoing other clinical trials for lung nodules will not be eligible. Overall, this study hopes to improve the way lung nodules are diagnosed and managed, ultimately benefiting patient care.

Gender

ALL

Eligibility criteria

• 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