Clinical trial NCT03224754: Atypia of Undetermined Significance (AUS) / Follicular Lesion of Undetermined Significance (FLUS)
Official title: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diagnoses Disease
Keywords: Atypia, thyroid, malignancy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient that has a diagnosis of atypia of undetermined significance/ follicular lesion of undetermined significance after thyroid fine needle aspiration regardless the age, sex or any other condition.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of malignant cases in a subsequent thyroidectomy after a diagnosis of AUS/ FLUS
timeFrame: From April 1st/ 2010 to December 31st 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Maria F Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jo VY, Stelow EB, Dustin SM, Hanley KZ. Malignancy risk for fine-needle aspiration of thyroid lesions according to the Bethesda System for Reporting Thyroid Cytopathology. Am J Clin Pathol. 2010 Sep;134(3):450-6. doi: 10.1309/AJCP5N4MTHPAFXFB.
citation: Baloch ZW, Cibas ES, Clark DP, Layfield LJ, Ljung BM, Pitman MB, Abati A. The National Cancer Institute Thyroid fine needle aspiration state of the science conference: a summation. Cytojournal. 2008 Apr 7;5:6. doi: 10.1186/1742-6413-5-6. No abstract available.
citation: Cibas ES, Ali SZ. The Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2009 Nov;19(11):1159-65. doi: 10.1089/thy.2009.0274.
citation: Marchevsky AM, Walts AE, Bose S, Gupta R, Fan X, Frishberg D, Scharre K, Zhai J. Evidence-based evaluation of the risks of malignancy predicted by thyroid fine-needle aspiration biopsies. Diagn Cytopathol. 2010 Apr;38(4):252-9. doi: 10.1002/dc.21185.
citation: Renshaw A. An estimate of risk of malignancy for a benign diagnosis in thyroid fine-needle aspirates. Cancer Cytopathol. 2010 Aug 25;118(4):190-5. doi: 10.1002/cncy.20092.
citation: Ho AS, Sarti EE, Jain KS, Wang H, Nixon IJ, Shaha AR, Shah JP, Kraus DH, Ghossein R, Fish SA, Wong RJ, Lin O, Morris LG. Malignancy rate in thyroid nodules classified as Bethesda category III (AUS/FLUS). Thyroid. 2014 May;24(5):832-9. doi: 10.1089/thy.2013.0317. Epub 2014 Mar 10.
citation: Kim TH, Jeong DJ, Hahn SY, Shin JH, Oh YL, Ki CS, Kim JW, Jang JY, Cho YY, Chung JH, Kim SW. Triage of patients with AUS/FLUS on thyroid cytopathology: effectiveness of the multimodal diagnostic techniques. Cancer Med. 2016 May;5(5):769-77. doi: 10.1002/cam4.636. Epub 2016 Jan 18.
citation: Singh RS, Wang HH. Eliminating the "Atypia of Undetermined Significance/Follicular Lesion of Undetermined Significance" category from the Bethesda System for Reporting Thyroid Cytopathology. Am J Clin Pathol. 2011 Dec;136(6):896-902. doi: 10.1309/AJCPIX52MBOKTICP.
citation: Yoo MR, Gweon HM, Park AY, Cho KE, Kim JA, Youk JH, Son EJ. Repeat Diagnoses of Bethesda Category III Thyroid Nodules: What To Do Next? PLoS One. 2015 Jun 26;10(6):e0130138. doi: 10.1371/journal.pone.0130138. eCollection 2015.