Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
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.
Checked against the public recordLast updated Nov 13, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Veracyte, Inc.
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Trinity Health Of New EnglandHartford, Connecticut
- The Stamford Health/The Stamford HospitalStamford, Connecticut
- Bay Pines VA HCSBay Pines, Florida
- North Florida/South Georgia Veterans Health SystemGainesville, Florida
- Bruce W. Carter Miami VA Medical CenterMiami, Florida
- Orlando VA Healthcare SystemOrlando, Florida
- Northwestern UniversityChicago, Illinois
- OSF Saint Francis Medical CenterPeoria, Illinois
- University of Kansas Medical CenterKansas City, Kansas
- Lexington VA Health Care SystemLexington, Kentucky
- Robley Rex VA Medical CenterLouisville, Kentucky
- Southeast Louisiana Veterans Health Care SystemNew Orleans, Louisiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2024. Always confirm current availability with the study team.