Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Registry for Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170804
• Other study ID #: 20162786
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2017
• Last updated: May 26, 2017
• Start date: January 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2017
• Source: Aventura Hospital and Medical Center
• Contact: Seza Gulec, MD
• Phone: 7866930821
• Email: sgulec[@]fiu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thymic Carcinoma
• Thymoma
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Locations

Country	Name	City	State
United States	Aventura Hospital and Medical Center	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aventura Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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