ClinicalTrials.gg
RecruitingNCT06426628NIGHTINGALEUpdated Nov 13, 2024

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

An observational study in Pulmonary Nodule, Solitary and Lung Cancer, sponsored by Veracyte, Inc.. Recruiting at 23 sites in 2 countries. Open to participants aged 29 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Veracyte, Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 3 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,400
Ages
29 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 27 studies in Solitary Pulmonary Nodule with a site in United States — 4 open to participants now, 8 under way, none of them phase 3. Solitary Pulmonary Nodule · United States.

Planned enrollment
Largest of 15
2,400 · median 187
Started
2022
with 2 others
Observational
15 of 27
3 open now
Registered
25th of 27
by date

Among the 27 studies in Solitary Pulmonary Nodule with a site in United States, this one has the largest planned enrollment of the 15 observational ones that give a count, is one of 3 that started in 2022, is one of 15 observational ones, and was the 25th registered.

Solitary Pulmonary Nodule

93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.

Browse Solitary Pulmonary Nodule studies →

Open to participants now

4 of the 27 studies in Solitary Pulmonary Nodule with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 12 Solitary Pulmonary Nodule studies recruiting now, 6 (50%) set no upper age limit and 1 (8%) stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 29 Years to 85 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 27 studies in Solitary Pulmonary Nodule with a site in United States, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Pulmonary Nodule, Solitary
  • Lung Cancer
04

Who can participate

Ages eligible
29 Years to 85 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to tolerate nasal epithelial specimen collection
  • Signed written 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

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 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 other than clinically validated risk calculators
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Number of invasive diagnostic procedures

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

    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

  1. Time to treatment

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

    Time frame: From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.

07

Study locations

22 of 23 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for Dec 2024, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2024
First posted
May 23, 2024
StartActual
Jul 18, 2022
Primary completionEst.
Dec 31, 2024
CompletionEst.
Mar 31, 2027
Last update
Nov 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06426628
Lead sponsor
Veracyte, Inc.
Responsible party
Sponsor
First posted
May 23, 2024
Start date
Jul 18, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Nov 13, 2024

Study contacts

Lori Lofaro, MSHS
Contact
lori.lofaro@veracyte.com
6502436389
Phillip G Febbo, MD
study chair · Veracyte, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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