NCT06426628Recruiting
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2400 (estimated)
- First submitted
- 10 May 2024
- Start date
- 18 Jul 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Veracyte, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT06426628
What you commit to
- Study type: Observational
- Planned participants: 2400
- From 18 Jul 2022 to the primary completion date, 31 Dec 2024
- 23 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators
Other illness
- Active cancer (other than non-melanoma skin cancer)
Other
- Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule
Who the study is looking for
- 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
Age in the registry: 29 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Caribbean Healthcare Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Bay Pines VA HCS Coordinator of this site? Confirm its status | Bay Pines | United States | Recruiting |
| Boston University Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Ralph H. Johnson VA Health Care System Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| North Florida/South Georgia Veterans Health System Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| PulmonIx, LLC Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Trinity Health Of New England Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Saint Lukes Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Lexington VA Health Care System Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Robley Rex VA Medical Center Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Bruce W. Carter Miami VA Medical Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Southeast Louisiana Veterans Health Care System Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Orlando VA Healthcare System Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| The Stamford Health/The Stamford Hospital Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| Mercy Health St. Vincent Medical Center Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| Good Samaritan Cancer Center Coordinator of this site? Confirm its status | West Islip | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.