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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veracyte, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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