Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-85
SponsorVeracyte, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,400 Participants
are grouped into 2 trial groupsGroup A: Test Arm
Group B: Control Arm
Trial outcomes
Primary outcomes
1
Number of invasive diagnostic procedures
Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign.
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.Secondary outcomes
1
Time to treatment
Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer
Time frame
From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov