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Clinical Trials in the USA / NCT06426628
Recruiting Observational

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

NCT06426628 · tracked via the Priya Life Science USA tracker
Sponsor
Veracyte, Inc.
Phase
Observational
Started
2022-07-18
Last updated
2024-11-13

Condition(s) studied

Pulmonary Nodule, SolitaryLung Cancer

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

Sex
ALL
Min age
29 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
Trinity Health Of New England Hartford Connecticut Recruiting
The Stamford Health/The Stamford Hospital Stamford Connecticut Recruiting
Bay Pines VA HCS Bay Pines Florida Recruiting
North Florida/South Georgia Veterans Health System Gainesville Florida Recruiting
Bruce W. Carter Miami VA Medical Center Miami Florida Recruiting
Orlando VA Healthcare System Orlando Florida Recruiting
Northwestern University Chicago Illinois Recruiting
OSF Saint Francis Medical Center Peoria Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Lexington VA Health Care System Lexington Kentucky Recruiting
Robley Rex VA Medical Center Louisville Kentucky Recruiting
Southeast Louisiana Veterans Health Care System New Orleans Louisiana Recruiting
University of Maryland Medical Center Baltimore Maryland Recruiting
Boston University Medical Center Boston Massachusetts Recruiting
Saint Lukes Hospital Kansas City Missouri Recruiting
Mercy Hospital Springfield Missouri Recruiting
University of Rochester Medical Center Rochester New York Recruiting
Good Samaritan Cancer Center West Islip New York Not Yet Recruiting
PulmonIx, LLC Greensboro North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Mercy Health St. Vincent Medical Center Toledo Ohio Recruiting
Ralph H. Johnson VA Health Care System Charleston South Carolina Recruiting
VA Caribbean Healthcare San Juan Puerto Rico Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06426628 on ClinicalTrials.gov ↗ ← All trials in the USA