Thyroid Imaging Reporting and Data System (TIRADS ) Versus Thyroid Association (ATA) Guidelines

NCT03517267 | Unknown DMC

• 1 other identifier: : RambamMC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

ultrasound and FNA DIAGNOSTIC_TEST

The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred for thyroid nodule FNA

You may qualify if:

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

You may not qualify if:

• \# Patients younger that 18

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israek, Israel

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

NIRA BECK-RAZI, MD

CONTACT

97247772664; n_beck_razi@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Ultrasound Unit

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 7, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)