Actively Recruiting
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Led by Veracyte, Inc. · Updated on 2024-11-13
2400
Participants Needed
23
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 90 days prior to nasal sample collection
- CT report available for index nodule
- Age between 29 and 85 years
- Current or former smoker (more than 100 cigarettes in a lifetime)
- Pulmonary nodule 30 mm or smaller detected by CT
You will not qualify if you...
- Active cancer other than non-melanoma skin cancer
- Prior primary lung cancer (prior non-lung cancer acceptable)
- Prior participation in this study
- Current active treatment with an investigational device or drug
- Patient enrolled or planned to be enrolled in another clinical trial that may influence nodule management
- Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 23 locations
1
Trinity Health Of New England
Hartford, Connecticut, United States, 06105
Actively Recruiting
2
The Stamford Health/The Stamford Hospital
Stamford, Connecticut, United States, 06904
Actively Recruiting
3
Bay Pines VA HCS
Bay Pines, Florida, United States, 33744
Actively Recruiting
4
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Actively Recruiting
5
Bruce W. Carter Miami VA Medical Center
Miami, Florida, United States, 33125
Actively Recruiting
6
Orlando VA Healthcare System
Orlando, Florida, United States, 32827
Actively Recruiting
7
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
8
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
9
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Actively Recruiting
10
Lexington VA Health Care System
Lexington, Kentucky, United States, 40502
Actively Recruiting
11
Robley Rex VA Medical Center
Louisville, Kentucky, United States, 40206
Actively Recruiting
12
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States, 70119
Actively Recruiting
13
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
14
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
15
Saint Lukes Hospital
Kansas City, Missouri, United States, 64111
Actively Recruiting
16
Mercy Hospital
Springfield, Missouri, United States, 65804
Actively Recruiting
17
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
18
Good Samaritan Cancer Center
West Islip, New York, United States, 11795
Not Yet Recruiting
19
PulmonIx, LLC
Greensboro, North Carolina, United States, 27401
Actively Recruiting
20
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
21
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Actively Recruiting
22
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States, 29401
Actively Recruiting
23
VA Caribbean Healthcare
San Juan, Puerto Rico, 00921-3201
Actively Recruiting
Research Team
L
Lori Lofaro, MSHS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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