Clinical Utility of Management of Patients With 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.

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Key information

Conditions

Pulmonary Nodule, Solitary Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Neoplasms

Age range

29 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Caribbean Healthcare, San Juan, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lori Lofaro, MSHS

CONTACT

[email protected]

6502436389

Sponsors and collaborators

Lead sponsor

Veracyte, Inc.

Industry

Registry information

Official study title

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

Acronym: NIGHTINGALE

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2027
First posted: May 23, 2024
Registry last updated: Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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