Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
NIGHTINGALE
1 other identifier
observational
2,400
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2022
CompletedFirst Submitted
Initial submission to the registry
May 10, 2024
CompletedFirst Posted
Study publicly available on registry
May 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedNovember 13, 2024
November 1, 2024
2.5 years
May 10, 2024
November 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of invasive diagnostic procedures
Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign.
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
From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.
Study Arms (2)
Test Arm
Percepta Nasal Swab test result will be returned to the physician investigator.
Control Arm
Percepta Nasal Swab test result will not be returned to the physician investigator.
Eligibility Criteria
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
You may qualify if:
- 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
- years of age
- Current or former smoker (\>100 cigarettes in a lifetime)
- Pulmonary nodule ≤30 mm detected by CT
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Veracyte, Inc.lead
Study Sites (23)
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
VA Caribbean Healthcare
San Juan, 00921-3201, Puerto Rico
Biospecimen
Nasal swab
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Phillip G Febbo, MD
Veracyte, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2024
First Posted
May 23, 2024
Study Start
July 18, 2022
Primary Completion
December 31, 2024
Study Completion (Estimated)
March 31, 2027
Last Updated
November 13, 2024
Record last verified: 2024-11