RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier

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

Condition
Pulmonary Nodule, Solitary
Intervention / Treatment

-

Contacts and Locations

Hartford

Trinity Health Of New England, Hartford, Connecticut, United States, 06105

Stamford

The Stamford Health/The Stamford Hospital, Stamford, Connecticut, United States, 06904

Bay Pines

Bay Pines VA HCS, Bay Pines, Florida, United States, 33744

Gainesville

North Florida/South Georgia Veterans Health System, Gainesville, Florida, United States, 32608

Miami

Bruce W. Carter Miami VA Medical Center, Miami, Florida, United States, 33125

Orlando

Orlando VA Healthcare System, Orlando, Florida, United States, 32827

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Peoria

OSF Saint Francis Medical Center, Peoria, Illinois, United States, 61637

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66103

Lexington

Lexington VA Health Care System, Lexington, Kentucky, United States, 40502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

29 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Veracyte, Inc.,

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

Study Record Dates

2027-03-31