Lung Cancer Clinical Trial
— NIGHTINGALEOfficial title:
Clinical Utility of Management of Patients With CT and LDCT Identified 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.
Status | Recruiting |
Enrollment | 2400 |
Est. completion date | December 30, 2026 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 29 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
United States | PulmonIx, LLC | Greensboro | North Carolina |
United States | The Stamford Health/The Stamford Hospital | Stamford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Veracyte, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of invasive diagnostic procedures | Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign. | 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. | |
Secondary | Time to treatment | Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer | From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months. |
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