Pulmonary Nodule, SolitaryNIGHTINGALENCT06426628
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
An observational study of Pulmonary Nodule, Solitary and Lung Cancer, run by Veracyte, Inc. at 23 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 29 to 85 years
- Conditions the study is for
- Pulmonary Nodule, Solitary, Lung Cancer
- How many people
- 2,400 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 18 Jul 2022to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 85 years
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 2 countries
United States22 sites, 22 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Van Holden, MD, 410-328-8141, vholden@som.umaryland
Van Holden, MD
- Recruiting
Bay Pines VA HCS
Bay Pines, Florida, 33744
Stephen R Clum, MD PhD, 727-398-6661 ext. 15785, stephen.clum@va.gov
Stephen R Clum, MD PhD
- Recruiting
Boston University Medical Center
Boston, Massachusetts, 02118
Ehab Billatos, MD, 617-358-7039, ebillato@bu.edu
Ehab Billatos, MD
- Recruiting
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401
Abby Wenzel, PhD, 843-789-6965, abby.wenzel@va.gov
Nichole T Tanner, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Phillip Cooper, 312-503-0406, p-cooper@northwestern.edu
Momen M Wahidi, MD
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Christopher C Radchenko, MD, 513-558-4831, radchecr@ucmail.uc.edu
Christopher C Radchenko, MD
- Recruiting
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
Juliana Venetucci, 352-548-7707, Juliana.Venetucci@va.gov
Peruvemba S Sriram, MD
- Recruiting
PulmonIx, LLC
Greensboro, North Carolina, 27401
Bradley L Icard, DO, 336-522-8870, pulmonixresearch@protonmail.com
Bradley L Icard, DO
- Recruiting
Trinity Health Of New England
Hartford, Connecticut, 06105
Anil Magge, MD, 860-714-4055, anil.magge@trinityhealthofne.org
Anil Magge, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103
Vianca Williams, MCR, CCRP, 913-588-2814, vwilliams6@kumc.edu
Maykol R Postigo, MD
- Recruiting
Saint Lukes Hospital
Kansas City, Missouri, 64111
Matthew Aboudara, MD, 816-756-2255, maboudara@saint-lukes.org
Matthew Aboudara, MD
- Recruiting
Lexington VA Health Care System
Lexington, Kentucky, 40502
Rebekah Evans, N, BSN, CCRP, 859-233-4511 ext. 5223, Rebekah.evans1@va.gov
Mouna Abouamara, MD
- Recruiting
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
Fred Hendler, MD, PhD, 502-287-5131, Fred.Hendler@va.gov
Fred Hendler, MD, PhD
- Recruiting
Bruce W. Carter Miami VA Medical Center
Miami, Florida, 33125
Jalima Quintero, RN, 305-575-7000 ext. 14580, Jalima.Quintero@va.gov
Gregory E Holt, MD
- Recruiting
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119
Sarah Savaski, 504-507-2000 ext. 63453, sarah.savaski@va.gov
David Becnel, MD
- Recruiting
Orlando VA Healthcare System
Orlando, Florida, 32827
Nazia Sultana, MD, 407-631-2040, Nazia.sultana@va.gov
Nazia Sultana, MD
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Kimberly Hartwig, RN, BSN, 309-655-4229, Kimberly.Hartwig@osfhealthcare.org
Patrick E Whitten, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Michael Nead, MD, PhD, 585-276-7294, Michael_Nead@urmc.rochester.edu
Michael Nead, MD, PhD
- Recruiting
Mercy Hospital
Springfield, Missouri, 65804
Madhu Kalyan Pendurthi, MD MPH, 417-820-8161, mpendur1@mercy.net
Madhu Kalyan Pendurthi, MD MPH
- Recruiting
The Stamford Health/The Stamford Hospital
Stamford, Connecticut, 06904
Majed Albache, MD, MPH, 203-276-4362, Malbache@stamhealth.org
Adrienne S Scott, MS, CCRC, 203-276-4362, Ascott@stamhealth.org
- Recruiting
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
Dee Tilley, RN, CCRC, 419-251-4919, dee_tilley@mercy.com
Vinod Khatri, MD
- Not yet recruiting
Good Samaritan Cancer Center
West Islip, New York, 11795
Stephanie E Solito, MBA, CCRC, 631-417-8611, Stephanie.Solito@chsli.org
Sharad Chandrika, MD
Puerto Rico1 site, 1 recruiting
- Recruiting
VA Caribbean Healthcare
San Juan, 00921-3201
Jose Torres-Palacios, MD, 787-641-7582 ext. 110116, jose.torres-palacios@va.gov
Jose Torres-Palacios, MD
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Pulmonary Nodule, Solitary, Lung Cancer
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of invasive diagnostic procedures
Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign.
Measured: 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 (1)
Time to treatment
Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer
Measured: From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start18 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veracyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip G Febbo, MD, Study chair, Veracyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426628
- Sponsor's protocol ID
- DHF009-050P
- Acronym
- NIGHTINGALE
- Status last verified
- Nov 2024
- First submitted
- 10 May 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
- ClinicalTrials.gov ID
- NCT06426628
- Acronym / sponsor ID
- NIGHTINGALE / DHF009-050P
- Conditions
- Pulmonary Nodule, Solitary, Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Veracyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 29 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phillip G Febbo, MD study chair
Veracyte, Inc.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Lung Cancer, run by Veracyte, Inc. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Lofaro, MSHS (6502436389, lori.lofaro@veracyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.