Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
NCT ID: NCT04411290
Last Updated: 2020-06-02
Study Results
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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UNKNOWN
200 participants
OBSERVATIONAL
2020-05-15
2021-06-01
Brief Summary
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Detailed Description
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The purpose of the present study is to detect the accuracy of preoperative cytology and US-findings (TI-RADS) and the prevalence of thyroid carcinoma in patients operated for thyroid diseases and to discuss all malignancy risk factors in detail along with final histopathological report. Cytology-histology discrepant cases will also be further evaluated for sampling and interpretation errors, and possible solutions to increase the accuracy of preop testing are going to be proposed. The accuracy of the preference of total thyroidectomy procedure will be evaluated considering the prevalence of incidental carcinomas diagnosed postoperatively, and whether there are variations in the risk of malignancy with respect to final pathology of patients will also be discussed in detail.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total Thyroidectomy (TT)-indicated patients
Patients with presumably benign thyroid disease (multinodular goitre, solitary thyroid nodule, toxic goitre, etc.) Patients with thyroid carcinoma (biopsy-proved) Total thyroidectomy preference by the primary surgeon
Total thyroidectomy (TT)
Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)
Interventions
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Total thyroidectomy (TT)
Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)
Eligibility Criteria
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Inclusion Criteria
* All patients should have a malignancy predictive factors forms filled in
* All patients should have fine needle aspiration cytology (Bethesda category) available
* All patients should have an ultrasound evaluated according to TI-RADS
* All patients should have a final histopathology report
Exclusion Criteria
* Age\<17 years
17 Years
ALL
No
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
Assoc. Professor of General Surgery and Surgical Oncology
Principal Investigators
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Ethem UNAL, MD, PhD
Role: STUDY_CHAIR
Assoc. Professor of General Surgery and Surgical Oncology
Sema YUKSEKDAG, MD
Role: PRINCIPAL_INVESTIGATOR
Instructor in General Surgery
Locations
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Umraniye Education and Research Hospital, Health Sciences Universit
Istanbul, , Turkey (Türkiye)
Countries
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References
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Delfim RLC, Veiga LCGD, Vidal APA, Lopes FPPL, Vaisman M, Teixeira PFDS. Likelihood of malignancy in thyroid nodules according to a proposed Thyroid Imaging Reporting and Data System (TI-RADS) classification merging suspicious and benign ultrasound features. Arch Endocrinol Metab. 2017 May-Jun;61(3):211-221. doi: 10.1590/2359-3997000000262. Epub 2017 Mar 27.
Tufano RP, Noureldine SI, Angelos P. Incidental thyroid nodules and thyroid cancer: considerations before determining management. JAMA Otolaryngol Head Neck Surg. 2015 Jun;141(6):566-72. doi: 10.1001/jamaoto.2015.0647.
Tan H, Li Z, Li N, Qian J, Fan F, Zhong H, Feng J, Xu H, Li Z. Thyroid imaging reporting and data system combined with Bethesda classification in qualitative thyroid nodule diagnosis. Medicine (Baltimore). 2019 Dec;98(50):e18320. doi: 10.1097/MD.0000000000018320.
Study Documents
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Document Type: Principal investigator data
View DocumentOther Identifiers
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B.10.1.TKH.4.34.H.GP.0.01/172
Identifier Type: -
Identifier Source: org_study_id
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