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

Recruitingn/aAges 29 Years - 85 YearsAllVeracyte, Inc.
NCT06426628 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

23 sites
Trinity Health Of New England
Hartford, United States
The Stamford Health/The Stamford Hospital
Stamford, United States
Bay Pines VA HCS
Bay Pines, United States
North Florida/South Georgia Veterans Health System
Gainesville, United States
Bruce W. Carter Miami VA Medical Center
Miami, United States
Orlando VA Healthcare System
Orlando, United States
Northwestern University
Chicago, United States
OSF Saint Francis Medical Center
Peoria, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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