Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VA Caribbean Healthcare
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
University of Maryland Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Bay Pines VA HCS
Coordinator of this site? Confirm its status
Bay PinesUnited StatesRecruiting
Boston University Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Ralph H. Johnson VA Health Care System
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
North Florida/South Georgia Veterans Health System
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
PulmonIx, LLC
Coordinator of this site? Confirm its status
GreensboroUnited StatesRecruiting
Trinity Health Of New England
Coordinator of this site? Confirm its status
HartfordUnited StatesRecruiting
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Saint Lukes Hospital
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Lexington VA Health Care System
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Robley Rex VA Medical Center
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Bruce W. Carter Miami VA Medical Center
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Southeast Louisiana Veterans Health Care System
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting
Orlando VA Healthcare System
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
OSF Saint Francis Medical Center
Coordinator of this site? Confirm its status
PeoriaUnited StatesRecruiting
University of Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Mercy Hospital
Coordinator of this site? Confirm its status
SpringfieldUnited StatesRecruiting
The Stamford Health/The Stamford Hospital
Coordinator of this site? Confirm its status
StamfordUnited StatesRecruiting
Mercy Health St. Vincent Medical Center
Coordinator of this site? Confirm its status
ToledoUnited StatesRecruiting
Good Samaritan Cancer Center
Coordinator of this site? Confirm its status
West IslipUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.