Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer

NCT03170804 | Unknown

• 1 other identifier: 20162786
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Thyroid Nodule; Thyroid Cancer; Thyroid Diseases; Thymic Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aventura Hospital and Medical Center: lead

Study Sites (1)

Aventura Hospital and Medical Center

Aventura, Florida, 33180, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms; Thyroid Diseases; Thymoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Thymus Neoplasms; Thoracic Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Seza Gulec, MD

  Aventura Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seza Gulec, MD

CONTACT

7866930821; sgulec@fiu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)