Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases

NCT ID: NCT04411290

Last Updated: 2020-06-02

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-06-01

Brief Summary

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In the last decades, thyroid cancer incidence has continuously increased all over the world, almost exclusively due to a sharp rise in the incidence of the papillary histologic subtype, which has the highest incidence of multifocality. Furthermore, Black Sea and Eastern European regions are both endemic and known to have been under the influence of Chernobyl nuclear explosion. Although overscreening might have a role in certain parts of the world, the predictors of malignancy such as family history, genetical disorders, previous radiation exposure, low iodine intake, diabetes and obesity, should also be taken into consideration in determining the extent of surgery.

Detailed Description

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High-frequency ultrasound (US) is increasingly used to help distinguish malignancy in patients with solitary or multiple nodules, and US-guided fine needle aspiration (FNA) has become the gold standard test for detecting thyroid cancer. Moreover, a further US-based risk stratification of thyroid nodules with Thyroid Imaging Reporting and Data System (TI-RADS) has been currently proposed for better and easier decision making. However, the presence of multiple nodules in the thyroid gland may decrease the diagnostic value of these preoperative diagnostic tools. The prevalence of incidental carcinoma identified on the final histological examination of the patients who underwent surgery for presumably benign thyroid diseases was previously reported to be roughly around 5 to 10%. Most of the previous studies also showed a lower risk of carcinoma in multinodular goitre (MNG) compared to solitary thyroid nodule (STN). However, some recent surgical series have reported that the risk of thyroid carcinoma in benign thyroid diseases is significantly higher than previously reported.

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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Multinodular Goiter, Adolescent Solitary Thyroid Nodule Thyroid Diseases Multifocal Dysplasia Aspiration Thyroid Nodule Thyroid Cancer, Papillary Thyroid Neoplasms Thyroid Goiter Thyroid Carcinoma Thyroid Papillary Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \>17 years all patients with benign/malign thyroid disease, total thyroidectomy is indicated/preferred by both primary surgeon and patient (signed informed consent is a must)
* 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

* Patients who are prepared for thyroid surgery other than total thyroidectomy procedure
* Age\<17 years
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic

Assoc. Professor of General Surgery and Surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status

Countries

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Turkey (Türkiye)

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.

Reference Type RESULT
PMID: 28699990 (View on PubMed)

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.

Reference Type RESULT
PMID: 25928353 (View on PubMed)

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.

Reference Type RESULT
PMID: 31852120 (View on PubMed)

Study Documents

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Document Type: Principal investigator data

View Document

Other 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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