Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Veracyte, Inc.
2,400 participants
Jul 18, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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
- years of age
- Current or former smoker (\>100 cigarettes in a lifetime)
- Pulmonary nodule ≤30 mm detected by CT
Exclusion Criteria6
- 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
Locations(23)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06426628