Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology (TIRADS)

July 21, 2020 updated by: Sabahattin Destek, Bezmialem Vakif University

Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology

The investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients' thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5 -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign, malignant).

Documents of 88 patients who were included in the study and who underwent thyroidectomy were reviewed.Pathology reports of these patients were evaluated and surgical pathology was determined as benign in 58 patients and malignant in 30 patients.

Then, a statistical study was performed between the cor needle biopsy (CNB) results of these participants and the surgical pathology and TI-RADS scores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

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

24 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thyroid biopsy data of 691 women and 69 men aged between 24-85 years were evaluated.

Description

Inclusion Criteria:

  • Having a thyroid nodule
  • Being both a thyroid needle and a core biopsy

Exclusion Criteria:

  • Child patients
  • Pregnant patients
  • Patients without a thyroid needle biopsy

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroid fine needle aspiration biopsy group
A group of 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis.
Procedure: Thyroid biopsy with ultrasound
Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.
Other Names:
  • Total thyroidectomy
Thyroid core needle aspiration biopsy group
A patient group with 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis and who underwent a core needle biopsy again. A total thyroidectomy was performed in 88 of these patients. Surgical pathology results, core needle results and TIRADS scores were compared.
Procedure: Thyroid biopsy with ultrasound
Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.
Other Names:
  • Total thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the distribution of patients according to thyroid biopsy results.
Time Frame: 4-year results were included.
Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.
4-year results were included.
Examination of TIRADS score distribution according to thyroid biopsy results.
Time Frame: 4-year results were included.
Thyroid biopsy results (benign, malignant) will be compared with the percentage of patients who fit the TIRADS score distribution (1-5). It will be analyzed statistically.
4-year results were included.
Evaluation of the compliance of TI-RADS scores with surgical pathology reports.
Time Frame: 4-year results were included.
Surgical pathology results (benign, malignant) and TI-RADS scores (1 to 5) will be compared with% of patients matching the distribution (1-5). It will be analyzed statistically.
4-year results were included.
Evaluation of the distribution of thyroid biopsy results and surgical pathology results.
Time Frame: 4-year results were included.
The % of patients who match the distribution of thyroid biopsy results (benign, malignant) and surgical pathology results (benign, malignant) will be compared. It will be analyzed statistically.
4-year results were included.

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: Beyza Benturk, Dr, Bezmialem Vakif University

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)

January 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8131643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We retrospectively analyzed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. We retrospectively analyzed the medical records of 760 patients who had undergone thyroid fine needle aspiration biopsy and core needle biopsy (CNB) and 88 patients who had thyroid surgery. After the study, core needle biopsy results were statistically compatible with Thyroid Imaging Reporting and Data System (TI-RADS) scores and surgical pathology results in patients. As a result, CNB is a reliable diagnostic method.

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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