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临床试验/NCT03517267
NCT03517267Unknown不适用

Validation of the New Thyroid Imaging Reporting and Data System (TIRADS) From 2017 Risk Assessment of Thyroid Nodules in Comparison to the American Thyroid Association (ATA) Guidelines From 2015

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Validation of Risk stratifications

研究概览

简要总结

Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice in order to determine the nodules nature . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .

The American Thyroid Association (ATA) is widely used as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid.

The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification

详细描述

Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice with sensitivity and specificity were 89.5% and 98%, respectively in order to determine the nodules nature, . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .

The American Thyroid Association (ATA) guidelines which characterized the nodule by its size, echogenicity, shape, presence or absence of calcification and evidence of Extrathyroidal extension (ETE) is widely use as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. These nodule characteristics classify the risk for malignancy into five categories which include benign pattern, very low suspicion pattern, low suspicion pattern, intermediate suspicious pattern and high suspicion pattern .

The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid nodules .The ultrasound features set by TIRADS include composition, echogenicity, shape, margins and echogenic foci. The scoring range according suspicion of malignancy.

The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification.

Methods

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients referred for thyroid nodule FNA from outpatient and in patient clinics
  • •Patients older that 18

排除标准

  • •# Patients younger that 18

结局指标

主要结局

Validation of Risk stratifications

时间窗: The outcome measures will be assessed within 1 year from the initiation of recruitment.

All nodules that will be aspirated , will be categorized according to the two risk stratification methods: Thyroid Imaging Reporting and Data System (TIRADS) and the American Thyroid Association (ATA) guidelines. The cytology results will be documented in the form of Bethesda scoring The risk stratification results will be compared to the Cytology results that will be considered the gold standard for malignancy . Accuracy of each method will be calculated .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

razi-Beck Nira MD

Director Ultrasound Unit

Rambam Health Care Campus

研究点 (1)

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