Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
The purpose of this registry is to collect uniform genomics-centered data on patients with
 nodular thyroid disease and cancer in a prospective fashion. After initial clinical
 evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation
 and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as
 clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A
 molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will
 be performed as per clinically determined indications. Standard surgical pathology will be
 processed and reported per the institutional policy and procedures. A molecular/genomic
 profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients
 undergoing thyroid nodule work-up may be enrolled. The registry will collect patient
 demographic and clinical data, cytopathology reports, and surgical pathology reports and
 slides (if/when a review is required).
This is an open-ended prospective registry. The patients who were diagnosed with thyroid
 nodules will have a complete clinical and US evaluation. Thyroid nodule biopsy indication and
 FNA vs core biopsy choices will be made entirely on the clinical grounds, by the managing
 physicians. Thyroid nodule biopsies may be performed at a participating medical or surgical
 endocrinology office. Following standard cytologic examination a molecular testing using
 Thyroseq will be performed.

 The biopsy results will be categorized according to Bethesda scoring system. Category I is
 non-diagnostic FNA and will require a repeat FNA. Category II is benign cytology, categories
 III, IV and V are the indeterminate group, and category VI is malignant cytology. The FNA
 analysis of registry patients will be collected under six groups. Thyroseq molecular testing
 may be deferred if not felt needed following cytology.

 1. Cytology(benign) / Thyroseq(-)

 2. Cytology(benign) / Thyroseq(+)

 3. Cytology(indeterminate) / Thyroseq(-)

 4. Cytology(indeterminate) / Thyroseq(+)

 5. Cytology(Malignant) / Thyroseq(-)

 6. Cytology(Malignant) / Thyroseq(+). Thyroid operation indication and lobectomy vs total
 thyroidectomy choices will be made entirely on the clinical grounds, by the managing
 physicians. The routine histopathology will be processed and reported as per the
 institutional protocols. The molecular testing of the preoperatively biopsied and
 intraoperatively and postoperatively identified lesions will be performed, as indicated.

 The registry is open to all interested physicians involved in thyroid patient care and
 interested in participating
Inclusion Criteria:

 -  Patients will be eligible for registry enrollment if they are undergoing thyroid
 nodule work-up.

 Exclusion Criteria:

 -  Patients will not be eligible for registry enrollment if a work-up beyond clinical
 evaluation is not indicated.