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

NCT ID: NCT03224754

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-05-02

Brief Summary

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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

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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.

Conditions

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Diagnoses Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Determination 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maria F. Gonzalez

Assisstant Professor of the department of Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria F Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20716802 (View on PubMed)

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.

Reference Type RESULT
PMID: 18394201 (View on PubMed)

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

Reference Type RESULT
PMID: 19888858 (View on PubMed)

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.

Reference Type RESULT
PMID: 19813257 (View on PubMed)

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.

Reference Type RESULT
PMID: 20586117 (View on PubMed)

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.

Reference Type RESULT
PMID: 24341462 (View on PubMed)

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.

Reference Type RESULT
PMID: 26775803 (View on PubMed)

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.

Reference Type RESULT
PMID: 22095375 (View on PubMed)

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.

Reference Type RESULT
PMID: 26115096 (View on PubMed)

Other Identifiers

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2017-0075

Identifier Type: -

Identifier Source: org_study_id

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