Recruiting

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

Sponsor:

Veracyte, Inc.

Code:

NCT06426628

Conditions

Pulmonary Nodule, Solitary

Lung Cancer

Eligibility Criteria

Sex: All

Age: 29 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Pulmonary Nodule, Solitary

Lung Cancer

Study ID

NCT06426628

Start date

Jul 18, 2022

Status verified date

Nov, 2024

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 29 - 70+

Healthy Volunteers: Not accepted

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 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 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

Study Design

Enrollment

2400 participants

Anticipated

Interventions and Outcome Measures

Arms

Test Arm

Percepta Nasal Swab test result will be returned to the physician investigator.

Control Arm

Percepta Nasal Swab test result will not be returned to the physician investigator.

Primary outcome measure

Number of invasive diagnostic procedures [ Time Frame: From date of randomization until the date the nodule is diagnosed as benign or demonstrates up to 24 months radiographic stability or resolution, assessed up to a total of 30 months. ]

Central Contacts and Locations

Central contacts

Lori Lofaro, MSHS

6502436389 lori.lofaro@veracyte.com

Locations

Trinity Health Of New England

Recruiting

Hartford, Connecticut, United States, 06105

Contacts

Anil Magge, MD

860-714-4055 anil.magge@trinityhealthofne.org

Principal Investigator:

Anil Magge, MD

The Stamford Health/The Stamford Hospital

Recruiting

Stamford, Connecticut, United States, 06904

Contacts

Majed Albache, MD, MPH

203-276-4362 Malbache@stamhealth.org

Adrienne S Scott, MS, CCRC

203-276-4362 Ascott@stamhealth.org

Principal Investigator:

Michael A Bernstein, MD

Bay Pines VA HCS

Recruiting

Bay Pines, Florida, United States, 33744

Contacts

Stephen R Clum, MD PhD

727-398-6661 stephen.clum@va.gov

Principal Investigator:

Stephen R Clum, MD PhD

North Florida/South Georgia Veterans Health System

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Juliana Venetucci

352-548-7707 Juliana.Venetucci@va.gov

Principal Investigator:

Peruvemba S Sriram, MD

Bruce W. Carter Miami VA Medical Center

Recruiting

Miami, Florida, United States, 33125

Contacts

Jalima Quintero, RN

305-575-7000 Jalima.Quintero@va.gov

Principal Investigator:

Gregory E Holt, MD

Orlando VA Healthcare System

Recruiting

Orlando, Florida, United States, 32827

Contacts

Nazia Sultana, MD

407-631-2040 Nazia.sultana@va.gov

Principal Investigator:

Nazia Sultana, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Phillip Cooper

312-503-0406 p-cooper@northwestern.edu

Principal Investigator:

Momen M Wahidi, MD

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Kimberly Hartwig, RN, BSN

309-655-4229 Kimberly.Hartwig@osfhealthcare.org

Principal Investigator:

Patrick E Whitten, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Vianca Williams, MCR, CCRP

913-588-2814 vwilliams6@kumc.edu

Principal Investigator:

Maykol R Postigo, MD

Lexington VA Health Care System

Recruiting

Lexington, Kentucky, United States, 40502

Contacts

Rebekah Evans, N, BSN, CCRP

859-233-4511 Rebekah.evans1@va.gov

Principal Investigator:

Mouna Abouamara, MD

Robley Rex VA Medical Center

Recruiting

Louisville, Kentucky, United States, 40206

Contacts

Fred Hendler, MD, PhD

502-287-5131 Fred.Hendler@va.gov

Principal Investigator:

Fred Hendler, MD, PhD

Southeast Louisiana Veterans Health Care System

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Sarah Savaski

504-507-2000 sarah.savaski@va.gov

Principal Investigator:

David Becnel, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Van Holden, MD

410-328-8141 vholden@som.umaryland

Principal Investigator:

Van Holden, MD

Boston University Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Ehab Billatos, MD

617-358-7039 ebillato@bu.edu

Principal Investigator:

Ehab Billatos, MD

Saint Lukes Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Matthew Aboudara, MD

816-756-2255 maboudara@saint-lukes.org

Principal Investigator:

Matthew Aboudara, MD

Mercy Hospital

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Madhu Kalyan Pendurthi, MD MPH

417-820-8161 mpendur1@mercy.net

Principal Investigator:

Madhu Kalyan Pendurthi, MD MPH

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Michael Nead, MD, PhD

585-276-7294 Michael_Nead@urmc.rochester.edu

Principal Investigator:

Michael Nead, MD, PhD

PulmonIx, LLC

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Bradley L Icard, DO

336-522-8870 pulmonixresearch@protonmail.com

Principal Investigator:

Bradley L Icard, DO

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Christopher C Radchenko, MD

513-558-4831 radchecr@ucmail.uc.edu

Principal Investigator:

Christopher C Radchenko, MD

Mercy Health St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608

Contacts

Dee Tilley, RN, CCRC

419-251-4919 dee_tilley@mercy.com

Principal Investigator:

Vinod Khatri, MD

Ralph H. Johnson VA Health Care System

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Abby Wenzel, PhD

843-789-6965 abby.wenzel@va.gov

Principal Investigator:

Nichole T Tanner, MD

More Information

Sponsor

Veracyte, Inc.

Last update posted

Nov 13, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Veracyte, Inc. on 2024-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.