Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Recruiting · NCT06426628 · Observational (researchers observe without assigning treatment) · Lead sponsor: Veracyte, Inc.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
23 locations listed across 13 US states.
- Trinity Health Of New England - Hartford, Connecticut, United States
- The Stamford Health/The Stamford Hospital - Stamford, Connecticut, United States
- Bay Pines VA HCS - Bay Pines, Florida, United States
- North Florida/South Georgia Veterans Health System - Gainesville, Florida, United States
- Bruce W. Carter Miami VA Medical Center - Miami, Florida, United States
- Orlando VA Healthcare System - Orlando, Florida, United States
- Northwestern University - Chicago, Illinois, United States
- OSF Saint Francis Medical Center - Peoria, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Lexington VA Health Care System - Lexington, Kentucky, United States
- Robley Rex VA Medical Center - Louisville, Kentucky, United States
- Southeast Louisiana Veterans Health Care System - New Orleans, Louisiana, United States
- University of Maryland Medical Center - Baltimore, Maryland, United States
- Boston University Medical Center - Boston, Massachusetts, United States
- Saint Lukes Hospital - Kansas City, Missouri, United States
- Mercy Hospital - Springfield, Missouri, United States
- University of Rochester Medical Center - Rochester, New York, United States
- Good Samaritan Cancer Center - West Islip, New York, United States
- PulmonIx, LLC - Greensboro, North Carolina, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- Mercy Health St. Vincent Medical Center - Toledo, Ohio, United States
- Ralph H. Johnson VA Health Care System - Charleston, South Carolina, United States
- VA Caribbean Healthcare - San Juan, Puerto Rico