<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/NCT04500925</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-20-NC-TLV-704-16-CTIL</org_study_id>
    <nct_id>NCT04500925</nct_id>
  </id_info>
  <brief_title>The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience</brief_title>
  <official_title>The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</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>
      Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of&#xD;
      the risk for disease-specific recurrence is essential for deciding between partial (low risk)&#xD;
      and completion (high risk) thyroidectomies. Patients' preoperatively determined risk levels&#xD;
      are re-stratified according to surgical and final histopathological findings. The American&#xD;
      Thyroid Association 2015 guidelines suggest that patients with WDTC between 1-4 cm in size&#xD;
      and without suspicious features may be suitable candidates for partial thyroidectomy. The&#xD;
      incidence and clinical implications of high-risk features discovered postoperatively in&#xD;
      patients with preoperatively determined low-risk WDTC have not been previously reported.&#xD;
&#xD;
      Methods All thyroidectomies performed between 2006-2018 in the Tel Aviv Sourasky Medical&#xD;
      Center were included. Pre- and postoperative risk stratifications were performed, and the&#xD;
      rate of completion thyroidectomy was determined. Patients with 1-4 cm WDTC without evidence&#xD;
      of positive cervical lymph nodes, invasion to adjacent structures, or high-risk cytology were&#xD;
      considered at low risk for disease-specific recurrence and therefore suitable for lobectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>disease-specific recurrence</measure>
    <time_frame>2006-2018</time_frame>
    <description>WDTC recurrence</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">301</enrollment>
  <condition>Well Differentiated Thyroid Carcinoma</condition>
  <condition>Papillary Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>UPSCALED</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>NOT UPSCALED</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>UNILATERAL THYROIDECTOMY</intervention_name>
    <arm_group_label>NOT UPSCALED</arm_group_label>
    <arm_group_label>UPSCALED</arm_group_label>
    <other_name>TOTAL THYROIDECTOMY</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The medical charts of all patients who underwent thyroid surgery between January 2006 and&#xD;
        December 2018 in TASMC were retrieved. Most of them were females. The mean age of the&#xD;
        entire cohort was 49.59 ± 15.17 years (median 50 years, interquartile range 38-61].&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who underwent thyroid surgery (partial and total) between 2006-2018 at&#xD;
             Tel Aviv Sourasky Medical Center (TASMC) were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with evidence of cervical lymph node metastasis, other malignancies, adverse&#xD;
             imaging features (i.e., extracapsular spread of thyroid malignancy, vocal cord&#xD;
             paralysis or immobility in physical examination) were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Years</minimum_age>
    <maximum_age>61 Years</maximum_age>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low risk, Risk stratification, Partial thyroidectomy, Hemithyroidectomy, Completion Thyroidectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- 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/NCT04500925
org study id: TASMC-20-NC-TLV-704-16-CTIL
nct id: NCT04500925
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of
      the risk for disease-specific recurrence is essential for deciding between partial (low risk)
      and completion (high risk) thyroidectomies. Patients' preoperatively determined risk levels
      are re-stratified according to surgical and final histopathological findings. The American
      Thyroid Association 2015 guidelines suggest that patients with WDTC between 1-4 cm in size
      and without suspicious features may be suitable candidates for partial thyroidectomy. The
      incidence and clinical implications of high-risk features discovered postoperatively in
      patients with preoperatively determined low-risk WDTC have not been previously reported.

      Methods All thyroidectomies performed between 2006-2018 in the Tel Aviv Sourasky Medical
      Center were included. Pre- and postoperative risk stratifications were performed, and the
      rate of completion thyroidectomy was determined. Patients with 1-4 cm WDTC without evidence
      of positive cervical lymph nodes, invasion to adjacent structures, or high-risk cytology were
      considered at low risk for disease-specific recurrence and therefore suitable for lobectomy.
observational model: Cohort
time perspective: Retrospective
measure: disease-specific recurrence
time frame: 2006-2018
description: WDTC recurrence
arm group label: UPSCALED
arm group label: NOT UPSCALED
intervention type: Procedure
intervention name: UNILATERAL THYROIDECTOMY
arm group label: NOT UPSCALED
arm group label: UPSCALED
other name: TOTAL THYROIDECTOMY
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 38 Years
maximum age: 61 Years
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases
mesh term: Recurrence