IRB Study Number 21-259
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
This study evaluates how the addition of the Nodify XL2 test result impacts the clinical management of new, incidentally identified solid lung nodules assessed as low to moderate risk of cancer.
Inclusion Criteria
- Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
- Subject is > 40 years of age at the time of the discovery of the lung nodule of concern
Subject's lung nodule of concern meets the following:
a. Was incidentally identified
b. Is a solid nodule
c. Has maximal dimension of > 8mm and < 30mm
The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
- The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 50% or less
Exclusion Criteria
- Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure for the lung nodule of concern
- Nodule of concern is part-solid or Ground Glass Opacity (GGO)
- Nodule of concern was detected during lung cancer screening
- Prior diagnosis of lung cancer
- Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
- Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
- Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
- Any illness or factor that will inhibit compliance with study participation
