Clinical trial NCT04904159: Scoring System for Thyroid Gland Pathologies
Official title: A New Scoring System in the Diagnosis of Thyroid Gland Pathologies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Nodule
Thyroid Cancer
Keywords: TI-RADS
Bethesda
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Age
timeFrame: Before Surgery
measure: Gender
timeFrame: Before Surgery
measure: Smoking Status
timeFrame: Before Surgery
measure: Radiation to the Neck Area
timeFrame: Before Surgery
measure: History of Thyroiditis
timeFrame: Before Surgery
measure: Family History
timeFrame: Before Surgery
measure: Complaint
timeFrame: Before Surgery
measure: Thyroid Imaging Reporting and Data System ( TIRADS ) score
timeFrame: Before surgery
measure: Bethesda classification system for thyroid fine needle aspirates
timeFrame: Before surgery
measure: Thyroid Stimulating Hormone ( TSH ) levels
timeFrame: Before surgery
measure: Pathology results
timeFrame: Immediately after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar Tranining and Research Hospital
Study officials:
affiliation: Istanbul Dr. Lutfi Kirdar Kartal Training and Research Hospital
name: Hasan Fehmi Küçük, Prof.
role: STUDY_CHAIR
References:
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citation: 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.