Scoring System for Thyroid Gland Pathologies

NCT04904159 | Unknown

• 1 other identifier: 2021/514/198/20
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Nodule; Thyroid Cancer

Keywords

TI-RADS; Bethesda

Outcome Measures

Primary Outcomes (11)

• Age

  Years

  Before Surgery

• Gender

  Male - Female

  Before Surgery

• Smoking Status

  Yes or No

  Before Surgery

• Radiation to the Neck Area

  Yes or No

  Before Surgery

• History of Thyroiditis

  Yes or No

  Before Surgery

• Family History

  Presence of family members with any thyroid pathologies especially thyroid cancer

  Before Surgery

• Complaint

  Months

  Before Surgery

• 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

• 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

• 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

• 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

Study Arms (2)

Benign

Patients who have benign pathologies after thyroidectomy

Procedure: Lobectomy

Malign

Patients who have malign pathologies after thyroidectomy

Procedure: Thyroidectomy

Interventions

Thyroidectomy PROCEDURE

total thyroidectomy

Malign

Lobectomy PROCEDURE

Lobectomy

Benign

Eligibility Criteria

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

Study Population

Thyroidectomy, which is a routine operation in clinic ( unilateral, total, complementary, etc.) ) applied patients will be included in the study

You may qualify if:

• patients who undergone surgery for thyroid gland pathologies

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar Tranining and Research Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 25388058 BACKGROUND

• 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.

  PMID: 31552809 BACKGROUND

• 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 Aug;31(8):5689-5698. doi: 10.1007/s00330-021-07703-5. Epub 2021 Feb 18.

  PMID: 33599836 BACKGROUND

• 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.

  PMID: 33660454 BACKGROUND

• 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.

  PMID: 32733383 BACKGROUND

• 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.

  PMID: 32100197 BACKGROUND

• 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.

  PMID: 24930423 BACKGROUND

• Remonti LR, Kramer CK, Leitao 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.

  PMID: 25747526 BACKGROUND

• 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.

  PMID: 29703794 BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Interventions

Thyroidectomy; Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Hasan Fehmi Küçük, Prof.

  Istanbul Dr. Lutfi Kirdar Kartal Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: May 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)