## Protocol Section
### Identification Module
**NCT ID:** NCT06426628

**Acronym:** NIGHTINGALE

**Brief Title:** Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier

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

#### Organization Study ID Info
**ID:** DHF009-050P
#### Organization
**Class:** INDUSTRY
**Full Name:** Veracyte, Inc.
### Status Module
#### Completion Date
**Date:** 2026-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-07-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Veracyte, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Pulmonary Nodule, Solitary

- Lung Cancer

### Design Module

#### Bio Spec

**Description:** Nasal swab

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Percepta Nasal Swab test result will be returned to the physician investigator.

**Label:** Test Arm

#### Arm Group 2

**Description:** Percepta Nasal Swab test result will not be returned to the physician investigator.

**Label:** Control Arm

### Outcomes Module

#### Primary Outcomes

**Description:** Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign.

**Measure:** 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.

#### Secondary Outcomes

**Description:** Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer

**Measure:** 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.

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 85 Years

**Minimum Age:** 29 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lori.lofaro@veracyte.com

**Name:** Lori Lofaro, MSHS

**Phone:** 6502436389

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Stamford

**Contacts:**

***Contact 1:***

- **Email:** Malbache@stamhealth.org

- **Name:** Majed Albache, MD, MPH

- **Phone:** 203-276-4362

- **Role:** CONTACT

***Contact 2:***

- **Email:** Ascott@stamhealth.org

- **Name:** Adrienne S Scott, MS, CCRC

- **Phone:** 203-276-4362

- **Role:** CONTACT

**Country:** United States

**Facility:** The Stamford Health/The Stamford Hospital

**State:** Connecticut

**Status:** RECRUITING

**Zip:** 06904

**Location 2:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** p-cooper@northwestern.edu

- **Name:** Phillip Cooper

- **Phone:** 312-503-0406

- **Role:** CONTACT

**Country:** United States

**Facility:** Northwestern University

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60611

**Location 3:**

**City:** Greensboro

**Contacts:**

***Contact 1:***

- **Email:** pulmonixresearch@protonmail.com

- **Name:** Bradley L Icard, DO

- **Phone:** 336-522-8870

- **Role:** CONTACT

**Country:** United States

**Facility:** PulmonIx, LLC

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27401

#### Overall Officials

**Official 1:**

**Affiliation:** Veracyte, Inc.

**Name:** Phillip G Febbo, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M28260

- Name: Multiple Pulmonary Nodules

- Relevance: HIGH

- As Found: Pulmonary Nodules

- ID: M6303

- Name: Solitary Pulmonary Nodule

- Relevance: HIGH

- As Found: Pulmonary Nodule, Solitary

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055613

- Term: Multiple Pulmonary Nodules

- ID: D000003074

- Term: Solitary Pulmonary Nodule

### Misc Info Module

- Version Holder: 2024-05-31
