Actively Recruiting

Age: 29Years - 85Years
All Genders
NCT06426628

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

Age: 29Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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