Brief Title
Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
Official Title
Registry for Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
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
Study Type
Observational [Patient Registry]
Primary Outcome
prognostic value of Thyroseq v2 molecular/genomic profiling
Condition
Thyroid Nodule
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
January 1, 2017
Completion Date
January 1, 2020
Primary Completion Date
January 1, 2018
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.
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Seza Gulec, MD, 7866930821, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03170804
Organization ID
20162786
Responsible Party
Sponsor
Study Sponsor
Aventura Hospital and Medical Center
Study Sponsor
Seza Gulec, MD, Principal Investigator, Aventura Hospital and Medical Center
Verification Date
May 2017