This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as \< 50% risk of cancer by Mayo risk prediction algorithm.
Study Type
OBSERVATIONAL
Enrollment
2,000
University of Colorado
Aurora, Colorado, United States
Lung Nodule Diagnosis
Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution
Time frame: Up to 24 months
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