Clinical trial NCT06426628: Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Official title: Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Nodule, Solitary
Lung Cancer
Lead sponsor: Veracyte, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-23
Enrollment: 2400
Sex: ALL
Minimum age (years): 29
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Current or former smokers (\>100 cigarettes in a lifetime) who are 29 - 85 years of age with a newly identified pulmonary nodule ≤30 mm detected by CT

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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Number of invasive diagnostic procedures
timeFrame: 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.
Secondary outcomes:
measure: Time to treatment
timeFrame: From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Trinity Health Of New England
state: Connecticut
city: Stamford
country: United States
facility: The Stamford Health/The Stamford Hospital
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA HCS
state: Florida
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Miami
country: United States
facility: Bruce W. Carter Miami VA Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando VA Healthcare System
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Lexington VA Health Care System
state: Kentucky
city: Louisville
country: United States
facility: Robley Rex VA Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Lukes Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: West Islip
country: United States
facility: Good Samaritan Cancer Center
state: New York
city: Greensboro
country: United States
facility: PulmonIx, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System
state: South Carolina
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare
Study officials:
affiliation: Veracyte, Inc.
name: Phillip G Febbo, MD
role: STUDY_CHAIR
References: