Atypia of Undetermined Significance (AUS) / Follicular Lesion of Undetermined Significance (FLUS)

Withdrawn

• Conditions: Diagnoses Disease

• Registration Number: NCT03224754
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

According to the guidelines for reporting thyroid fine needle aspirations known as The Bethesda System, the category of atypical cells known as AUS/ FLUS category has an estimated rate of 5 to 15% for malignancy. This study aims to determine the rate of malignancy of this category in our institution and to evaluate the clinical outcome of the participants.

Detailed Description

This is a retrospective study that will help us to find out the rate of AUS/ FLUS in our population of Mississippi and the percentage of malignancies in these cases.The specimens will be searched through the University of Mississippi Medical Center's Pathology Laboratory Information system (Copath), from April 2010 to December 2016. The retrospective cases will be retrieved using natural language search. The total number of thyroid FNA will be retrieved and the percentage of cases with AUS/ FLUS will be calculated. Followup of these cases will be done looking for additional fine needle aspirations of the thyroid or thyroidectomy specimens. Cases with diagnosis of AUS/ FLUS will have correlation with the diagnosis on the thyroidectomy specimens if available in our system.

Study Timeline

• Study Start: 2017-07-18
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2018-05
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Thyroid fine needle aspirations interpreted as AUS/ FLUS at University of Mississippi Medical Center from April 2010 to December 2016.

Exclusion Criteria

• Fine needle aspirations of thyroid with diagnosis of unsatisfactory, benign, suspicious for follicular neoplasm/ Follicular neoplasm, suspicious for malignancy and malignant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of malignant cases in a subsequent thyroidectomy after a diagnosis of AUS/ FLUS	From April 1st/ 2010 to December 31st 2016	All the cytology cases with a diagnosis of AUS/FLUS on fine needle aspiration from April 1st 2010 to December 31st 2016 will be retrieved using the University Medical Center's pathology information system (Copath). Follow-up of these cases will be done looking for percentage of malignancy in these cases.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States