Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer

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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