To perform a post-market study of the performance of the Idylla™ ThyroidPrint® Assay using clinical samples in predicting the nature of indeterminate thyroid nodules (ITNs) across multiple centers.
Thyroid nodule ≥1.0 cm
With indeterminate cytology
Surgery due to be performed
Specimens which fail to meet the inclusion criteria.
FNA fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions.
RNA extracts.
Patients with ultrasound evidence of malignant cervical adenopathy
The study population is defined as cases where the thyroid nodule has been reported as indeterminate.
Case-only
Other
Not listed
Primary endpoints
to measure the accuracy of the Thyroid print test against the surgical pathology report.
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