Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
NCT ID: NCT06426628
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2400 participants
OBSERVATIONAL
2022-07-18
2027-03-31
Brief Summary
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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.
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Detailed Description
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The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Test Arm
Percepta Nasal Swab test result will be returned to the physician investigator.
No interventions assigned to this group
Control Arm
Percepta Nasal Swab test result will not be returned to the physician investigator.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
29 Years
85 Years
ALL
No
Sponsors
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Veracyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phillip G Febbo, MD
Role: STUDY_CHAIR
Veracyte, Inc.
Locations
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Trinity Health Of New England
Hartford, Connecticut, United States
The Stamford Health/The Stamford Hospital
Stamford, Connecticut, United States
Bay Pines VA HCS
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
Bruce W. Carter Miami VA Medical Center
Miami, Florida, United States
Orlando VA Healthcare System
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Lexington VA Health Care System
Lexington, Kentucky, United States
Robley Rex VA Medical Center
Louisville, Kentucky, United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
Saint Lukes Hospital
Kansas City, Missouri, United States
Mercy Hospital
Springfield, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Good Samaritan Cancer Center
West Islip, New York, United States
PulmonIx, LLC
Greensboro, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
VA Caribbean Healthcare
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DHF009-050P
Identifier Type: -
Identifier Source: org_study_id
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