Clinical Utility of Management of Patients With 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 13, 2024 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Veracyte, Inc.
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Trinity Health Of New EnglandHartford, Connecticut
- The Stamford Health/The Stamford HospitalStamford, Connecticut
- Bay Pines VA HCSBay Pines, Florida
- North Florida/South Georgia Veterans Health SystemGainesville, Florida
- Bruce W. Carter Miami VA Medical CenterMiami, Florida
- Orlando VA Healthcare SystemOrlando, Florida
- Northwestern UniversityChicago, Illinois
- OSF Saint Francis Medical CenterPeoria, Illinois
- University of Kansas Medical CenterKansas City, Kansas
- Lexington VA Health Care SystemLexington, Kentucky
- Robley Rex VA Medical CenterLouisville, Kentucky
- Southeast Louisiana Veterans Health Care SystemNew Orleans, Louisiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2024. Always confirm current availability with the study team.