Clinical trial NCT03170804: Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
Official title: Registry for Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Nodule
Thyroid Cancer
Thyroid Diseases
Thymic Carcinoma
Lead sponsor: Aventura Hospital and Medical Center
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: prognostic value of Thyroseq v2 molecular/genomic profiling
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Aventura Hospital and Medical Center
state: Florida
Study officials:
affiliation: Aventura Hospital and Medical Center
name: Seza Gulec, MD
role: PRINCIPAL_INVESTIGATOR
References: