NCT04488640

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

July 15, 2020

Last Update Submit

July 21, 2020

Conditions

Thyroid Nodule

Keywords

TI-RADS scoreThyroid fine needle aspiration biopsyThyroid core needle biopsySurgical pathology

Outcome Measures

Primary Outcomes (4)

  • Evaluation of the distribution of patients according to thyroid biopsy results.

    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.

    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.

    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.

    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.

Study Arms (2)

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

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

Interventions

Thyroid biopsy with ultrasoundPROCEDURE

Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.

Also known as: Total thyroidectomy
Thyroid core needle aspiration biopsy groupThyroid fine needle aspiration biopsy group

Eligibility Criteria

Age24 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Singh Ospina N, Brito JP, Maraka S, Espinosa de Ycaza AE, Rodriguez-Gutierrez R, Gionfriddo MR, Castaneda-Guarderas A, Benkhadra K, Al Nofal A, Erwin P, Morris JC, Castro MR, Montori VM. Diagnostic accuracy of ultrasound-guided fine needle aspiration biopsy for thyroid malignancy: systematic review and meta-analysis. Endocrine. 2016 Sep;53(3):651-61. doi: 10.1007/s12020-016-0921-x. Epub 2016 Apr 12.

    PMID: 27071659RESULT

  • Singaporewalla RM, Hwee J, Lang TU, Desai V. Clinico-pathological Correlation of Thyroid Nodule Ultrasound and Cytology Using the TIRADS and Bethesda Classifications. World J Surg. 2017 Jul;41(7):1807-1811. doi: 10.1007/s00268-017-3919-5.

    PMID: 28251273RESULT

  • Lew JI, Snyder RA, Sanchez YM, Solorzano CC. Fine needle aspiration of the thyroid: correlation with final histopathology in a surgical series of 797 patients. J Am Coll Surg. 2011 Jul;213(1):188-94; discussion 194-5. doi: 10.1016/j.jamcollsurg.2011.04.029. Epub 2011 May 20.

    PMID: 21601489RESULT

  • Kim SY, Lee HS, Moon J, Kim EK, Moon HJ, Yoon JH, Kwak JY. Fine-needle aspiration versus core needle biopsy for diagnosis of thyroid malignancy and neoplasm: a matched cohort study. Eur Radiol. 2017 Feb;27(2):801-811. doi: 10.1007/s00330-016-4424-1. Epub 2016 Jun 3.

    PMID: 27260342RESULT

  • Hahn SY, Shin JH, Oh YL, Park KW, Lim Y. Comparison Between Fine Needle Aspiration and Core Needle Biopsy for the Diagnosis of Thyroid Nodules: Effective Indications According to US Findings. Sci Rep. 2020 Mar 18;10(1):4969. doi: 10.1038/s41598-020-60872-z.

    PMID: 32188891RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Thyroid biopsy preparations Thyroidectomy specimen preparations

MeSH Terms

Conditions

Thyroid Nodule

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Beyza Benturk, Dr

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical associate professor

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 28, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

May 1, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07