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

NCT06426628 · Veracyte, Inc.
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Official title
Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
About this study
This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules. The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.
Eligibility criteria
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
Study design
Enrollment target: 2400 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-07-18
Estimated completion: 2027-03-31
Last updated: 2024-11-13
Primary outcomes
  • Number of invasive diagnostic procedures (From date of randomization until the date the nodule is diagnosed as benign or demonstrates up to 24 months radiographic stability or resolution, assessed up to a total of 30 months.)
Sponsor
Veracyte, Inc. · industry
Contacts & investigators
ContactLori Lofaro, MSHS · contact · lori.lofaro@veracyte.com · 6502436389
InvestigatorPhillip G Febbo, MD · study_chair, Veracyte, Inc.
All locations (23)
Trinity Health Of New EnglandRecruiting
Hartford, Connecticut, United States
The Stamford Health/The Stamford HospitalRecruiting
Stamford, Connecticut, United States
Bay Pines VA HCSRecruiting
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health SystemRecruiting
Gainesville, Florida, United States
Bruce W. Carter Miami VA Medical CenterRecruiting
Miami, Florida, United States
Orlando VA Healthcare SystemRecruiting
Orlando, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
OSF Saint Francis Medical CenterRecruiting
Peoria, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Lexington VA Health Care SystemRecruiting
Lexington, Kentucky, United States
Robley Rex VA Medical CenterRecruiting
Louisville, Kentucky, United States
Southeast Louisiana Veterans Health Care SystemRecruiting
New Orleans, Louisiana, United States
University of Maryland Medical CenterRecruiting
Baltimore, Maryland, United States
Boston University Medical CenterRecruiting
Boston, Massachusetts, United States
Saint Lukes HospitalRecruiting
Kansas City, Missouri, United States
Mercy HospitalRecruiting
Springfield, Missouri, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
Good Samaritan Cancer CenterNot Yet Recruiting
West Islip, New York, United States
PulmonIx, LLCRecruiting
Greensboro, North Carolina, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
Mercy Health St. Vincent Medical CenterRecruiting
Toledo, Ohio, United States
Ralph H. Johnson VA Health Care SystemRecruiting
Charleston, South Carolina, United States
VA Caribbean HealthcareRecruiting
San Juan, Puerto Rico
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier · TrialPath