Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Recruiting now
Conditions studied: Pulmonary Nodule, Solitary, Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06426628
- Run by
- Veracyte, Inc.
- People needed
- 2400
- Starts
- 2022-07-18
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2024-11-13
Who can join
Age: 29 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Caribbean Healthcare — San Juan, Puerto Rico (enrolling)
- The Stamford Health/The Stamford Hospital — Stamford, Connecticut, United States (enrolling)
- Bay Pines VA HCS — Bay Pines, Florida, United States (enrolling)
- North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States (enrolling)
- Bruce W. Carter Miami VA Medical Center — Miami, Florida, United States (enrolling)
- Orlando VA Healthcare System — Orlando, Florida, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- OSF Saint Francis Medical Center — Peoria, Illinois, United States (enrolling)
- University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- Lexington VA Health Care System — Lexington, Kentucky, United States (enrolling)
- Robley Rex VA Medical Center — Louisville, Kentucky, United States (enrolling)
- Southeast Louisiana Veterans Health Care System — New Orleans, Louisiana, United States (enrolling)
- University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
- Boston University Medical Center — Boston, Massachusetts, United States (enrolling)
- Saint Lukes Hospital — Kansas City, Missouri, United States (enrolling)
- Mercy Hospital — Springfield, Missouri, United States (enrolling)
- University of Rochester Medical Center — Rochester, New York, United States (enrolling)
- Trinity Health Of New England — Hartford, Connecticut, United States (enrolling)
- PulmonIx, LLC — Greensboro, North Carolina, United States (enrolling)
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
- Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States (enrolling)
- Ralph H. Johnson VA Health Care System — Charleston, South Carolina, United States (enrolling)
- Good Samaritan Cancer Center — West Islip, New York, United States
Full record on ClinicalTrials.gov
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