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

Conditions

• Lung Cancer
• Pulmonary Nodule, Solitary

Eligibility Criteria

Sex

ALL

Age

29 Years - 85 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Jul 18, 2022

Status verified

Nov 2024

Primary completion

Dec 31, 2024

Completion

Mar 31, 2027

Study Design

Enrollment

2,400 participants (estimated)

Arms

• Arm: Test Arm
  Percepta Nasal Swab test result will be returned to the physician investigator.
• Arm: Control Arm
  Percepta Nasal Swab test result will not be returned to the physician investigator.

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. ]

Central Contacts

• Lori Lofaro, MSHS
  6502436389
  [email protected]

Locations (22)

Find similar trials in Hartford, CT

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