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

NCT04411290 | Unknown DMC

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01/172
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Total Thyroidectomy; Black Sea; Eastern Europe; Radiation; Endemic; Fine needle aspiration (FNA); Multifocality; Bethesda; Cytology; Thyroid Imaging Reporting and Data System (TI-RADS); International; Multi-centric; Multicentric study

Outcome Measures

Primary Outcomes (4)

• Preoperative Evaluation of Malignancy Risk Factors-How many risk factors are present?

  Malignancy risk factors: 1. Demographics (Age and gender-Male/Female), 2. Smoking history (Yes/No, duration and number/day), 3. Iodine-deficient diet (Yes/No), 4. Born at an endemic area (Yes/No), 5. Presence in an endemic area (Yes/No), 6. Radiation exposure (Yes/No), 7. Radiation treatment during childhood (Yes/No), 8. Head and neck carcinoma (Yes/No), 9. Other carcinoma history (Yes/No, if yes specify.........) 10. Family history of thyroid disease (Yes/No), 11. Family history of other carcinomas (Yes/No), 12. Personal history of thyroid carcinoma/surgery (Yes/No, if yes, pathology……..), 13. Personal history of other carcinomas (e.g. colonic polyps? breast disease?......) 14. Genetic disorders (Yes/No), 15. Obesity (Body mass index - ? kg/m2), 16. Diabetes mellitus (Yes/No) should be evaluated for each patient before surgery- The number of risk factors will be compared with malignancy rate found at final histopathology report.

  12 months

• Preoperative Bethesda category, Fine needle aspiration (FNA) cytology report

  Bethesda score-FNA cytology report- as I, II, III, IV, V or VI. Cytology report will be compared with final histology report for each patient for malşgnancy rate and multifocality I. Nondiagnostic or unsatisfactory, II. Benign, III. Atypia of undetermined significance (AUS) or follicular lesion of undetermined significance (FLUS), IV. Follicular neoplasm or suspicious for a follicular neoplasm-Preoperative cytology category will be compared with postoperative final histopathology report for malignancy rate, multifocality and cases with cytology-histopathology discrepancy will be evaluated further for biopsy techniques and cytology mis-interpretations. V. Suspicious for malignancy, VI. Malignant.

  12 months

• Preoperative ultrasound evaluation with Thyroid Imaging Reporting and Data System (TI-RADS)

  TI-RADS score-Ultrasound evaluation of thyroid nodues- as I, II, III, IV or V. TI-RADS scores will be compared with final histopathology report to see malignancy rates and accuracy of TI-RADS. TI-RADS 1: Normal thyroid gland. No focal lesion. TI-RADS 2: Benign nodules. Noticeably benign pattern (0% risk of malignancy) TI-RADS 3: Probably benign nodules (\<5% risk of malignancy) TI-RADS 4: * 4a - Undetermined nodules (5-10% risk of malignancy) Score of 1. * 4b - Suspicious nodules (10-50% risk of malignancy) Score of 2. * 4c - Highly suspicious nodules (50-85% risk of malignancy) Score of 3-4 TI-RADS 5: Probably malignant nodules (\>85% risk of malignancy) Score of 5 or higher TI-RADS 6: Biopsy-proven malignancy

  12 months

• Total thyroidectomy for both benign and malign thyroid diseases

  Final histopathology report-After surgery (all patients should have a final histopathology report after total thyroidectomy operation). Final histology report will be correlated to Malignancy risk factors (number), Bethesda category (accuracy, false negativity/positivity) and TI-RADS (accuracy, false negativity/positivity)

  12 months

Study Arms (1)

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

Procedure: Total thyroidectomy (TT)

Interventions

Total thyroidectomy (TT) PROCEDURE

Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)

Total Thyroidectomy (TT)-indicated patients

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with benign or malign thyroid disease, eligable for total thyroidectomy

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital, Health Sciences Universit

Istanbul, 34764, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28699990 RESULT

• 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.

  PMID: 25928353 RESULT

• 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.

  PMID: 31852120 RESULT

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary; Euthyroid Goiter; Thyroid Diseases; Thyroid Nodule; Goiter; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ethem UNAL, MD, PhD

  Assoc. Professor of General Surgery and Surgical Oncology

  STUDY CHAIR

• Sema YUKSEKDAG, MD

  Instructor in General Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor of General Surgery and Surgical Oncology

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: June 2, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: June 01, 2020
• Access Criteria: Contact for all available forms by email Open to all centers (especially for Black Sea and Estern European centers, but not limited to)

Locations

TU (1)