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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03170804
Other study ID # 20162786
Secondary ID
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
Health authority
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.

Study Design


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
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