Clinical Utility of Management of Patients with CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier (Protocol # DHF 009-050P)
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.
• A newly identified nodule is defined as any nodule first identified on imaging <90 days prior to nasal sample collection.
• CT imaging includes conventional CT, LDCT, HRCT
• Benign diagnosis is defined as a specific diagnosis of a benign condition, radiographic resolution or stability at ≥ 24 months, or no cytological, radiological, or pathological evidence of cancer.
• Procedures will be categorized as either invasive or non-invasive in the Data Management Plan (DMP).
• A newly identified nodule is defined as any nodule first identified on imaging <90 days prior to nasal sample collection.
• CT imaging includes conventional CT, LDCT, HRCT
• Benign diagnosis is defined as a specific diagnosis of a benign condition, radiographic resolution or stability at ≥ 24 months, or no cytological, radiological, or pathological evidence of cancer.
• Procedures will be categorized as either invasive or non-invasive in the Data Management Plan (DMP).
Contact
Clinical Trials Office at [email protected] or (203) 358-8879.
Principal Investigator(s)
Michael Bernstein, MD
Sponsor(s)
Veracyte, Inc.
Location
SHMG- Pulmonary Associates
29 Hospital Plaza
Stamford, CT 06902
Stamford, CT 06902