Scoring System for Thyroid Gland Pathologies

Thyroid Cancer Clinical Trial

Official title:

A New Scoring System in the Diagnosis of Thyroid Gland Pathologies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04904159
• Other study ID #: 2021/514/198/20
• Status: Enrolling by invitation
• Start date: May 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2021
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. As a result of all other criteria, a follow-up decision can be changed in a patient with a single fine needle aspiration biopsy result, or despite all the examinations the investigators have, a clear result cannot be achieved, and patient management may be disrupted. A holistic approach to thyroid gland pathologies is planned thanks to the scoring system that will be created in this study.

Description:

In routine clinical practice, the criteria the investigators consider during the pre - op period in patients evaluated due to thyroid pathologies include anamnesis, physical examination, laboratory values, especially thyroid function, thyroid-neck ultrasonographies, fine needle aspiration biopsies, according to which decisions about operation or nonoperative follow-up are made with the patient. The investigators aim to create a common scoring system by taking into account the pathology results of patients who have undergone thyroidectomy and comparing these results with the results of pre-op examination and thus to address patient management in a more objective and comprehensive way.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who undergone surgery for thyroid gland pathologies

Exclusion Criteria:

• patients who did not want to be involved in the study
• patients who missed in the follow-up period
• pregnant patients

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Procedure:
• Thyroidectomy
total thyroidectomy
• Lobectomy
Lobectomy

Locations

Country	Name	City	State
Turkey	Kartal Dr Lutfi Kirdar Tranining and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Chaigneau E, Russ G, Royer B, Bigorgne C, Bienvenu-Perrard M, Rouxel A, Leenhardt L, Belin L, Buffet C. TIRADS score is of limited clinical value for risk stratification of indeterminate cytological results. Eur J Endocrinol. 2018 Jul;179(1):13-20. doi: 10.1530/EJE-18-0078. Epub 2018 Apr 27. — View Citation

Cozzolino A, Pozza C, Pofi R, Sbardella E, Faggiano A, Isidori AM, Giannetta E, Pernazza A, Rullo E, Ascoli V, Lenzi A, Gianfrilli D. Predictors of malignancy in high-risk indeterminate (TIR3B) cytopathology thyroid nodules. J Endocrinol Invest. 2020 Aug;43(8):1115-1123. doi: 10.1007/s40618-020-01200-0. Epub 2020 Feb 25. — View Citation

Ianni F, Pascucci D, Paragliola RM, Rota CA, Perotti G, Fadda G, Pontecorvi A, Corsello SM. Follow-Up or Surgery for Indeterminate Thyroid Nodules: Could the CUT Score Application Be a Support for Decision-Making in the Preoperative Assessment? Thyroid. 2020 Jan;30(1):65-71. doi: 10.1089/thy.2018.0649. Epub 2019 Oct 23. — View Citation

Macias CA, Arumugam D, Arlow RL, Eng OS, Lu SE, Javidian P, Davidov T, Trooskin SZ. A risk model to determine surgical treatment in patients with thyroid nodules with indeterminate cytology. Ann Surg Oncol. 2015 May;22(5):1527-32. doi: 10.1245/s10434-014-4190-8. Epub 2014 Nov 12. — View Citation

Madeo B, Brigante G, Ansaloni A, Taliani E, Kaleci S, Monzani ML, Simoni M, Rochira V. The Added Value of Operator's Judgement in Thyroid Nodule Ultrasound Classification Arising From Histologically Based Comparison of Different Risk Stratification Systems. Front Endocrinol (Lausanne). 2020 Jul 7;11:434. doi: 10.3389/fendo.2020.00434. eCollection 2020. — View Citation

Maia FF, Matos PS, Pavin EJ, Zantut-Wittmann DE. Thyroid imaging reporting and data system score combined with Bethesda system for malignancy risk stratification in thyroid nodules with indeterminate results on cytology. Clin Endocrinol (Oxf). 2015 Mar;82(3):439-44. doi: 10.1111/cen.12525. Epub 2014 Jul 7. — View Citation

Remonti LR, Kramer CK, Leitão CB, Pinto LC, Gross JL. Thyroid ultrasound features and risk of carcinoma: a systematic review and meta-analysis of observational studies. Thyroid. 2015 May;25(5):538-50. doi: 10.1089/thy.2014.0353. Epub 2015 Mar 31. Review. — View Citation

Shin HS, Na DG, Paik W, Yoon SJ, Gwon HY, Noh BJ, Kim WJ. Malignancy Risk Stratification of Thyroid Nodules with Macrocalcification and Rim Calcification Based on Ultrasound Patterns. Korean J Radiol. 2021 Apr;22(4):663-671. doi: 10.3348/kjr.2020.0381. Epub 2021 Feb 2. — View Citation

Sparano C, Verdiani V, Pupilli C, Perigli G, Badii B, Vezzosi V, Mannucci E, Maggi M, Petrone L. Choosing the best algorithm among five thyroid nodule ultrasound scores: from performance to cytology sparing-a single-center retrospective study in a large cohort. Eur Radiol. 2021 Feb 18. doi: 10.1007/s00330-021-07703-5. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Years	Before Surgery
Primary	Gender	Male - Female	Before Surgery
Primary	Smoking Status	Yes or No	Before Surgery
Primary	Radiation to the Neck Area	Yes or No	Before Surgery
Primary	History of Thyroiditis	Yes or No	Before Surgery
Primary	Family History	Presence of family members with any thyroid pathologies especially thyroid cancer	Before Surgery
Primary	Complaint	Months	Before Surgery
Primary	Thyroid Imaging Reporting and Data System ( TIRADS ) score	Radiological features of throid nodule ( minimum value is 1 maximum value is 5 ); thyroid nodule which has a higher value means a worse outcome	Before surgery
Primary	Bethesda classification system for thyroid fine needle aspirates	Histopathological features of thyroid nodule ( minimum value is 1 maximum value is 6 ) thyroid nodule which has higher value means a worse outcome	Before surgery
Primary	Thyroid Stimulating Hormone ( TSH ) levels	it is a hormone secreted from the pituitary gland and triggers the functioning of the thyroid gland ( cut of values are 0.5 - 5.0 mIU / L )	Before surgery
Primary	Pathology results	The result of the throid gland part sent to the pathology unit after surgery ( the results can be benign or malign )	Immediately after the surgery