NCT06426628 · Veracyte, Inc.
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
(NIGHTINGALE)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Hartford, Connecticut
- Stamford, Connecticut
- Bay Pines, Florida
- Gainesville, Florida
- Miami, Florida
- Orlando, Florida
- Chicago, Illinois
- Peoria, Illinois
- Kansas City, Kansas
- Lexington, Kentucky
- Louisville, Kentucky
- New Orleans, Louisiana
And 10 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2024 · Source of record for eligibility and locations