Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Purpose
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.
Conditions
- Pulmonary Nodule, Solitary
- Lung Cancer
Eligibility
- Eligible Ages
- Between 29 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Test Arm | Percepta Nasal Swab test result will be returned to the physician investigator. | |
| Control Arm | Percepta Nasal Swab test result will not be returned to the physician investigator. |
Recruiting Locations
Hartford 4835797, Connecticut 4831725 06105
Stamford 4843564, Connecticut 4831725 06904
Bay Pines 4146855, Florida 4155751 33744
Gainesville 4156404, Florida 4155751 32608
Miami 4164138, Florida 4155751 33125
Orlando 4167147, Florida 4155751 32827
Chicago 4887398, Illinois 4896861 60611
Peoria 4905687, Illinois 4896861 61637
Kansas City 4273837, Kansas 4273857 66103
Lexington 4297983, Kentucky 6254925 40502
Louisville 4299276, Kentucky 6254925 40206
New Orleans 4335045, Louisiana 4331987 70119
Baltimore 4347778, Maryland 4361885 21201
Boston 4930956, Massachusetts 6254926 02118
Kansas City 4393217, Missouri 4398678 64111
Springfield 4409896, Missouri 4398678 65804
Rochester 5134086, New York 5128638 14642
Greensboro 4469146, North Carolina 4482348 27401
Cincinnati 4508722, Ohio 5165418 45267
Toledo 5174035, Ohio 5165418 43608
Charleston 4574324, South Carolina 4597040 29401
San Juan 4568127, Puerto Rico 00921-3201
More Details
- NCT ID
- NCT06426628
- Status
- Recruiting
- Sponsor
- Veracyte, Inc.
Detailed Description
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.