RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-18
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06426628

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.

Ages Eligible for Study:29 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to tolerate nasal epithelial specimen collection
  2. * Signed written Informed Consent obtained
  3. * Subject clinical history available for review by sponsor and regulatory agencies
  4. * New nodule identified on imaging \< 90 days prior to nasal sample collection
  5. * CT report available for index nodule
  6. * 29 - 85 years of age
  7. * Current or former smoker (\>100 cigarettes in a lifetime)
  8. * Pulmonary nodule ≤30 mm detected by CT
  1. * Active cancer (other than non-melanoma skin cancer)
  2. * Prior primary lung cancer (prior non-lung cancer acceptable)
  3. * Prior participation in this study (i.e., subjects may not be enrolled more than once)
  4. * Current active treatment with an investigational device or drug
  5. * Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule
  6. * Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators

Contacts and Locations

Study Contact

Lori Lofaro, MSHS
CONTACT
6502436389
lori.lofaro@veracyte.com

Principal Investigator

Phillip G Febbo, MD
STUDY_CHAIR
Veracyte, Inc.

Study Locations (Sites)

Trinity Health Of New England
Hartford, Connecticut, 06105
United States
The Stamford Health/The Stamford Hospital
Stamford, Connecticut, 06904
United States
Bay Pines VA HCS
Bay Pines, Florida, 33744
United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
United States
Bruce W. Carter Miami VA Medical Center
Miami, Florida, 33125
United States
Orlando VA Healthcare System
Orlando, Florida, 32827
United States
Northwestern University
Chicago, Illinois, 60611
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
University of Kansas Medical Center
Kansas City, Kansas, 66103
United States
Lexington VA Health Care System
Lexington, Kentucky, 40502
United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Boston University Medical Center
Boston, Massachusetts, 02118
United States
Saint Lukes Hospital
Kansas City, Missouri, 64111
United States
Mercy Hospital
Springfield, Missouri, 65804
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Good Samaritan Cancer Center
West Islip, New York, 11795
United States
PulmonIx, LLC
Greensboro, North Carolina, 27401
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401
United States

Collaborators and Investigators

Sponsor: Veracyte, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-18
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2022-07-18
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Nodule, Solitary
  • Lung Cancer