Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer

Registry for 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).

Study Overview

• Status: Unknown
• Conditions: Thyroid Diseases; Thymic Carcinoma; Thyroid Cancer; Thyroid Nodule

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
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Seza Gulec, MD; Phone Number: 7866930821; Email: sgulec@fiu.edu

Study Locations

• United States
  • Florida
    • Aventura, Florida, United States, 33180
      • Recruiting
      • Aventura Hospital and Medical Center
      • Contact: Hilda Mahmoudi, MD; Phone Number: 305-682-7261; Email: hilda.mahmoudi@hcahealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prognostic value of Thyroseq v2 molecular/genomic profiling	The purpose of this registry is to collect uniform data on patients with nodular thyroid disease and thyroid cancer in a prospective fashion. Data collected will primarily be analyzed for diagnostic and prognostic value of Thyroseq v2 molecular/genomic profiling.	an average of 1 year

Collaborators and Investigators

• Sponsor: Aventura Hospital and Medical Center
• Investigators: Principal Investigator: Seza Gulec, MD, Aventura Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Neoplasms, Complex and Mixed; Thymus Neoplasms; Thyroid Diseases; Thymoma; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: 20162786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No