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

Last updated: November 12, 2024
Sponsor: Veracyte, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Nodules

Non-small Cell Lung Cancer

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT06426628
DHF009-050P
  • Ages 29-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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 thanonce)

  • Current active treatment with an investigational device or drug

  • Patient enrolled or planned to be enrolled in another clinical trial that mayinfluence management of the patient's nodule

  • Concurrent or planned use of tools or tests for assigning lung nodule risk ofmalignancy other than clinically validated risk calculators

Study Design

Total Participants: 2400
Study Start date:
July 18, 2022
Estimated Completion Date:
March 31, 2027

Study Description

This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules.

The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.

Connect with a study center

  • VA Caribbean Healthcare

    San Juan, 00921-3201
    Puerto Rico

    Active - Recruiting

  • Trinity Health Of New England

    Hartford, Connecticut 06105
    United States

    Active - Recruiting

  • The Stamford Health/The Stamford Hospital

    Stamford, Connecticut 06904
    United States

    Active - Recruiting

  • Bay Pines VA HCS

    Bay Pines, Florida 33744
    United States

    Active - Recruiting

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Bruce W. Carter Miami VA Medical Center

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Orlando VA Healthcare System

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66103
    United States

    Active - Recruiting

  • Lexington VA Health Care System

    Lexington, Kentucky 40502
    United States

    Active - Recruiting

  • Robley Rex VA Medical Center

    Louisville, Kentucky 40206
    United States

    Active - Recruiting

  • Southeast Louisiana Veterans Health Care System

    New Orleans, Louisiana 70119
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Saint Lukes Hospital

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Mercy Hospital

    Springfield, Missouri 65804
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Good Samaritan Cancer Center

    West Islip, New York 11795
    United States

    Site Not Available

  • PulmonIx, LLC

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Active - Recruiting

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina 29401
    United States

    Active - Recruiting

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