Clinical trial · Observational
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
Correlation of Malignancy Predictors, Bethesda (I-VI) and TI-RADS Scores (I-V) With Final Histopathology in Patients Undergoing Total Thyroidectomy 34 Years After Chernobyl Disaster: Multi-centric Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aspiration | — | UNRESOLVED | — |
| Multifocal Dysplasia | — | UNRESOLVED | — |
| Multinodular Goiter, Adolescent | — | UNRESOLVED | — |
| Solitary Thyroid Nodule | — | UNRESOLVED | — |
| Thyroid Cancer, Papillary | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
| Thyroid Carcinoma | Thyroid Gland Carcinoma | ALIAS | 0.90 |
| Thyroid Diseases | — | UNRESOLVED | — |
| Thyroid Goiter | — | UNRESOLVED | — |
| Thyroid Neoplasms | Thyroid Gland Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total thyroidectomy (TT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Total Thyroidectomy (TT)-indicated patients
- description
- 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
- interventionNames
- Procedure: Total thyroidectomy (TT)
Primary outcomes (4)
- measure
- Preoperative Evaluation of Malignancy Risk Factors-How many risk factors are present?
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTDelfim 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
- RESULTTufano 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
- RESULTTan 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