Scoring System for Thyroid Gland Pathologies

May 27, 2021 updated by: Ramazan Sari, Dr. Lutfi Kirdar Kartal Training and Research Hospital

A New Scoring System in the Diagnosis of Thyroid Gland Pathologies

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34890
        • Kartal Dr Lutfi Kirdar Tranining and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign
Patients who have benign pathologies after thyroidectomy
Procedure: Lobectomy
Lobectomy
Malign
Patients who have malign pathologies after thyroidectomy
Procedure: Thyroidectomy
total thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Before Surgery
Years
Before Surgery
Gender
Time Frame: Before Surgery
Male - Female
Before Surgery
Smoking Status
Time Frame: Before Surgery
Yes or No
Before Surgery
Radiation to the Neck Area
Time Frame: Before Surgery
Yes or No
Before Surgery
History of Thyroiditis
Time Frame: Before Surgery
Yes or No
Before Surgery
Family History
Time Frame: Before Surgery
Presence of family members with any thyroid pathologies especially thyroid cancer
Before Surgery
Complaint
Time Frame: Before Surgery
Months
Before Surgery
Thyroid Imaging Reporting and Data System ( TIRADS ) score
Time Frame: Before surgery
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
Time Frame: Before surgery
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
Time Frame: Before surgery
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
Time Frame: Immediately after the surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

  • Study Chair: Hasan Fehmi Küçük, Prof., Istanbul Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 22, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/514/198/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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