RecruitingNCT06426628

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

Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier


Sponsor

Veracyte, Inc.

Enrollment

2,400 participants

Start Date

Jul 18, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 29 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a nasal swab test (Percepta Nasal Swab Classifier) to help doctors better predict whether a newly found lung nodule is cancerous. The test analyzes cells from the nose to look for gene activity patterns associated with lung cancer risk. **You may be eligible if...** - You are between 29 and 85 years old - You are a current or former smoker (more than 100 cigarettes in your lifetime) - A CT scan found a lung nodule 30 mm or smaller within the past 90 days - You can tolerate a nasal swab collection **You may NOT be eligible if...** - You currently have an active cancer (other than non-melanoma skin cancer) - You have had a previous lung cancer diagnosis - You have been enrolled in this study before - You are currently in another clinical trial that might affect how your lung nodule is managed - You are using other lung nodule risk assessment tools beyond standard validated calculators Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(23)

Trinity Health Of New England

Hartford, Connecticut, United States

The Stamford Health/The Stamford Hospital

Stamford, Connecticut, United States

Bay Pines VA HCS

Bay Pines, Florida, United States

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Bruce W. Carter Miami VA Medical Center

Miami, Florida, United States

Orlando VA Healthcare System

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Lexington VA Health Care System

Lexington, Kentucky, United States

Robley Rex VA Medical Center

Louisville, Kentucky, United States

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Saint Lukes Hospital

Kansas City, Missouri, United States

Mercy Hospital

Springfield, Missouri, United States

University of Rochester Medical Center

Rochester, New York, United States

Good Samaritan Cancer Center

West Islip, New York, United States

PulmonIx, LLC

Greensboro, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

VA Caribbean Healthcare

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06426628


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