An observational study in Thyroid Carcinoma, Thyroid Papillary Carcinoma and Multinodular Goiter, Adolescent, sponsored by Umraniye Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by Umraniye Education and Research Hospital · Observational
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.
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.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 200 is above the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Umraniye Education and Research Hospital is the lead sponsor of 61 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with benign or malign thyroid disease, eligable for total thyroidectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)
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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 12 months
Plan to share: Yes — All Excel documents will be available (Patient initials and medical record numbers shaded XX). Demographics, BMI, malignancy risk factors, Bethesda and TI-RADS scores and final histopathology reports
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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)
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Umraniye Education and Research Hospital