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

November 12, 2024 updated by: Veracyte, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules.

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.

Study Type

Observational

Enrollment (Estimated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
        • Recruiting
        • VA Caribbean Healthcare
        • Contact:
        • Principal Investigator:
          • Jose Torres-Palacios, MD
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Trinity Health Of New England
        • Contact:
        • Principal Investigator:
          • Anil Magge, MD
      • Stamford, Connecticut, United States, 06904
        • Recruiting
        • The Stamford Health/The Stamford Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael A Bernstein, MD
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines VA HCS
        • Contact:
        • Principal Investigator:
          • Stephen R Clum, MD PhD
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • North Florida/South Georgia Veterans Health System
        • Contact:
        • Principal Investigator:
          • Peruvemba S Sriram, MD
      • Miami, Florida, United States, 33125
        • Recruiting
        • Bruce W. Carter Miami VA Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory E Holt, MD
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Orlando VA Healthcare System
        • Contact:
        • Principal Investigator:
          • Nazia Sultana, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Momen M Wahidi, MD
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Patrick E Whitten, MD
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Maykol R Postigo, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Recruiting
        • Lexington VA Health Care System
        • Contact:
        • Principal Investigator:
          • Mouna Abouamara, MD
      • Louisville, Kentucky, United States, 40206
        • Recruiting
        • Robley Rex VA Medical Center
        • Contact:
        • Principal Investigator:
          • Fred Hendler, MD, PhD
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • Southeast Louisiana Veterans Health Care System
        • Contact:
        • Principal Investigator:
          • David Becnel, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
        • Principal Investigator:
          • Van Holden, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University Medical Center
        • Contact:
        • Principal Investigator:
          • Ehab Billatos, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Lukes Hospital
        • Principal Investigator:
          • Matthew Aboudara, MD
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Madhu Kalyan Pendurthi, MD MPH
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Nead, MD, PhD
      • West Islip, New York, United States, 11795
        • Not yet recruiting
        • Good Samaritan Cancer Center
        • Contact:
        • Principal Investigator:
          • Sharad Chandrika, MD
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Pulmonix, LLC
        • Contact:
        • Principal Investigator:
          • Bradley L Icard, DO
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Christopher C Radchenko, MD
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Mercy Health St. Vincent Medical Center
        • Principal Investigator:
          • Vinod Khatri, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H. Johnson VA Health Care System
        • Principal Investigator:
          • Nichole T Tanner, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of invasive diagnostic procedures
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to treatment
Time Frame: From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.
Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer
From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veracyte, Inc.

Investigators

  • Study Chair: Phillip G Febbo, MD, 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 Major Dates

Study Start (Actual)

July 18, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHF009-050P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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