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OpenTrials
Completed

NCT Number: NCT04488640

Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS 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.

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Key information

Age range

24 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroid biopsy with ultrasound

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Acronym: TIRADS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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