<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488640</url>
  </required_header>
  <id_info>
    <org_study_id>8131643</org_study_id>
    <nct_id>NCT04488640</nct_id>
  </id_info>
  <brief_title>Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology</brief_title>
  <acronym>TIRADS</acronym>
  <official_title>Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators retrospectively reviewed the medical records of 760 patients with thyroid&#xD;
      nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients'&#xD;
      thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System&#xD;
      scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5&#xD;
      -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle&#xD;
      aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign,&#xD;
      malignant).&#xD;
&#xD;
      Documents of 88 patients who were included in the study and who underwent thyroidectomy were&#xD;
      reviewed.Pathology reports of these patients were evaluated and surgical pathology was&#xD;
      determined as benign in 58 patients and malignant in 30 patients.&#xD;
&#xD;
      Then, a statistical study was performed between the cor needle biopsy (CNB) results of these&#xD;
      participants and the surgical pathology and TI-RADS scores.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the distribution of patients according to thyroid biopsy results.</measure>
    <time_frame>4-year results were included.</time_frame>
    <description>Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Examination of TIRADS score distribution according to thyroid biopsy results.</measure>
    <time_frame>4-year results were included.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the compliance of TI-RADS scores with surgical pathology reports.</measure>
    <time_frame>4-year results were included.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the distribution of thyroid biopsy results and surgical pathology results.</measure>
    <time_frame>4-year results were included.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>Thyroid fine needle aspiration biopsy group</arm_group_label>
    <description>A group of 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thyroid core needle aspiration biopsy group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thyroid biopsy with ultrasound</intervention_name>
    <description>Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.</description>
    <arm_group_label>Thyroid core needle aspiration biopsy group</arm_group_label>
    <arm_group_label>Thyroid fine needle aspiration biopsy group</arm_group_label>
    <other_name>Total thyroidectomy</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Thyroid biopsy preparations Thyroidectomy specimen preparations&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Thyroid biopsy data of 691 women and 69 men aged between 24-85 years were evaluated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a thyroid nodule&#xD;
&#xD;
          -  Being both a thyroid needle and a core biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child patients&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients without a thyroid needle biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beyza Benturk, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <results_reference>
    <citation>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.</citation>
    <PMID>27071659</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>28251273</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>21601489</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27260342</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>32188891</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Sabahattin Destek</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical associate professor</investigator_title>
  </responsible_party>
  <keyword>TI-RADS score</keyword>
  <keyword>Thyroid fine needle aspiration biopsy</keyword>
  <keyword>Thyroid core needle biopsy</keyword>
  <keyword>Surgical pathology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488640
org study id: 8131643
nct id: NCT04488640
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Evaluation of the distribution of patients according to thyroid biopsy results.
time frame: 4-year results were included.
description: Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.
measure: Examination of TIRADS score distribution according to thyroid biopsy results.
time frame: 4-year results were included.
description: 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.
measure: Evaluation of the compliance of TI-RADS scores with surgical pathology reports.
time frame: 4-year results were included.
description: 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.
measure: Evaluation of the distribution of thyroid biopsy results and surgical pathology results.
time frame: 4-year results were included.
description: 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.
arm group label: Thyroid fine needle aspiration biopsy group
description: A group of 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis.
arm group label: Thyroid core needle aspiration biopsy group
description: 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.
intervention type: Procedure
intervention name: Thyroid biopsy with ultrasound
description: Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.
arm group label: Thyroid core needle aspiration biopsy group
arm group label: Thyroid fine needle aspiration biopsy group
other name: Total thyroidectomy
Thyroid biopsy preparations Thyroidectomy specimen preparations
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: 85 Years
healthy volunteers: No
last name: Beyza Benturk, Dr
role: Study Chair
affiliation: Bezmialem Vakif University
citation: 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: 27071659
citation: 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: 28251273
citation: 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: 21601489
citation: 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: 27260342
citation: 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: 32188891
responsible party type: Principal Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Sabahattin Destek
investigator title: Principal Investigator, Clinical associate professor
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
sharing ipd: Undecided
ipd 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.