Tests a nasal swab test to guide care for lung nodules
Studies whether a nasal swab test helps doctors manage newly found lung nodules.
Plain-language title generated from the registry record
Registry title: Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Key facts
- Where
- San Juan, Puerto RicoSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 29 and 85 years old?
Source: NCT06426628, who can take part
Where in Puerto Rico
- VA Caribbean HealthcareSan Juan, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Veracyte, Inc.
- Trial code
- NCT06426628
- Record updated
- 13 November 2024
- Original 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.Read full original descriptionShow less
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:
* 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.
Inclusion: 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: 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; Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators; Active cancer (other than non-melanoma skin cancer); Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule.