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

Understanding Management and Clinical Follow-up of Atypia of Undetermined Significance / Follicular Lesion of Undetermined Significance Category in Thyroid Fine Needle Aspiration: A 6 Year-retrospective Study in a Tertiary Care Center.

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03224754
Enrollment
0
Registered
2017-07-21
Start date
2017-07-18
Completion date
2018-05-02
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease

Keywords

Atypia, thyroid, malignancy

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.

Interventions

BEHAVIORALDetermination of risk of malignancy of these thyroid lesions

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.

Sponsors

University of Mississippi Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of malignant cases in a subsequent thyroidectomy after a diagnosis of AUS/ FLUSFrom April 1st/ 2010 to December 31st 2016All 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026