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Observational Study of Percepta Nasal Swab for Lung Nodules

This study is looking at how doctors use the Percepta Nasal Swab test to manage patients who have a newly found spot on their lung, called a pulmonary nodule. The Percepta Nasal Swab is a test that uses a simple nasal swab. Researchers want to see if using this test helps reduce the number of invasive procedures (like biopsies) for people whose nodules are not cancerous, and if it helps people with cancerous nodules get treatment faster. You could join if you are 29-85 years old, a current or former smoker, and have a new lung nodule identified within the last 90 days. The study is currently unclear on its recruitment status and aims to enroll about 2400 people.

Study design
This is an observational, randomized study involving about 2400 participants. Participants will be randomly assigned to a group where their doctor receives the test results or a group where the doctor does not.
What's involved
You would need to be able to have a nasal swab collected. You will be followed for 24 to 30 months, or until a diagnosis of lung cancer.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 30 months, or until their nodule is diagnosed as benign or shows stability/resolution, or until a diagnosis of lung cancer.

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NCT06426628

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

Recruiting
Not specifiedAges 29–85Observational
Veracyte, Inc.
~2,400 participants
Updated 2024-11-13 on ClinicalTrials.gov

At a glance

Recruiting sites
22 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of invasive diagnostic procedures
Measured over 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.

Conditions

Pulmonary Nodule, Solitary
Lung Cancer

Explore related trials

Lung CarcinomaPulmonary Nodule

Where it's being run

23 sites across 14 states
Florida4
Connecticut2
Illinois2
Kentucky2
Missouri2
New York2
Ohio2
Kansas1

Study leadership

  • Phillip G Febbo, MD · STUDY_CHAIR · Veracyte, Inc.

Who to contact

Lori Lofaro, MSHS
[email protected]
6502436389
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of invasive diagnostic proceduresFrom 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.

    Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign.