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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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