Thyroid Nodule Clinical Trial
Official title:
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
NCT number | NCT03517267 |
Other study ID # | : RambamMC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | June 2019 |
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
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients referred for thyroid nodule FNA from outpatient and in patient clinics - Patients older that 18 Exclusion Criteria: # Patients younger that 18 |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa | Israek |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of Risk stratifications | 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 . |
The outcome measures will be assessed within 1 year from the initiation of recruitment. |
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