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

NCT03224754 | Withdrawn

• 1 other identifier: 2017-0075
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnoses Disease

Keywords

Atypia, thyroid, malignancy

Outcome Measures

Primary Outcomes (1)

• Number of malignant cases in a subsequent thyroidectomy after a diagnosis of AUS/ FLUS

  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.

  From April 1st/ 2010 to December 31st 2016

Interventions

Determination of risk of malignancy of these thyroid lesions BEHAVIORAL

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

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (9)

• 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.

  PMID: 20716802 RESULT

• 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.

  PMID: 18394201 RESULT

• Cibas ES, Ali SZ. The Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2009 Nov;19(11):1159-65. doi: 10.1089/thy.2009.0274.

  PMID: 19888858 RESULT

• 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.

  PMID: 19813257 RESULT

• 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.

  PMID: 20586117 RESULT

• 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.

  PMID: 24341462 RESULT

• 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.

  PMID: 26775803 RESULT

• 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.

  PMID: 22095375 RESULT

• 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.

  PMID: 26115096 RESULT

MeSH Terms

Conditions

Thyroid Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Maria F Gonzalez, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of the department of Pathology

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: July 18, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)