<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/NCT03294005</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH-ENDO2054</org_study_id>
    <nct_id>NCT03294005</nct_id>
  </id_info>
  <brief_title>Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography</brief_title>
  <official_title>Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</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>
      Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the&#xD;
      hypothyroidism with the popular name &quot;the big neck&quot;. After many experts study and evaluation,&#xD;
      goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the&#xD;
      thyroid gland was widespread on the Taiwan island. This situation was a particular victim in&#xD;
      living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid&#xD;
      gland disease really popular than other areas. Recently literature reported that the cancer&#xD;
      rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer&#xD;
      prevalence probably has 10% in the nodular goiter.&#xD;
&#xD;
      The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration&#xD;
      cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to&#xD;
      have special training cytological pathology doctor. Therefore, if we can have simple fast&#xD;
      screening tool and can make up this insufficiency, then we can achieved the fast diagnosis,&#xD;
      rapid processing, the promotion diagnosis and treatment quality and promotes the survival&#xD;
      percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the&#xD;
      simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early&#xD;
      diagnosis &amp; management this disease.&#xD;
&#xD;
      This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC&#xD;
      and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey&#xD;
      and analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy with (TP+TN)/(TP+TN+FP+TN)</measure>
    <time_frame>Jun 2018</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity with TP/(TP+FN)</measure>
    <time_frame>Jun 2018</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity with TN/(TN+FP)</measure>
    <time_frame>Jun 2018</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive predictive value (PPV) with TP/(TP+FP)</measure>
    <time_frame>Jun 2018</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value (NPV) with TN/(TN+FN)</measure>
    <time_frame>Jun 2018</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1949</enrollment>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Subjects with nodular goiter</arm_group_label>
    <description>Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH. Total enrolled subject about 2000. These subjects were confirmed by pathology. Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients. Gray scale ultrasonography was routinely performed in every subject. Color Doppler ultrasonography for blood flow and thyroid fine needle aspiration was not absolute done in routine procedure. All data at least was interpreted by 3 endocrinologists under the blind method. Each subject was analyzed under thyroid echogenicity, margin, calcification, inclusion, grooving change and size &amp; ratio size of tall and transverse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thyroid ultrasonography</intervention_name>
    <description>Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients.</description>
    <arm_group_label>Subjects with nodular goiter</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002&#xD;
        January to 2016 December in CMUH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Patients with nodular goiter had thyroidectomy from 2002 January to 2016 December&#xD;
             in CMUH.&#xD;
&#xD;
          -  2. Patients had thyroid sonography within one year before thyroidectomy.&#xD;
&#xD;
          -  3. All data at least was interpreted by 3 endocrinologists under the blind method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients with nodular goiter hadn't thyroidectomy.&#xD;
&#xD;
          -  2. Patients hadn't thyroid sonography.&#xD;
&#xD;
          -  3. All data was interpreted by endocrinologists under the blind method, but&#xD;
             interpretation results were inconsistent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Chwen-Tzuei Chang</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03294005
org study id: CMUH-ENDO2054
nct id: NCT03294005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the
      hypothyroidism with the popular name "the big neck". After many experts study and evaluation,
      goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the
      thyroid gland was widespread on the Taiwan island. This situation was a particular victim in
      living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid
      gland disease really popular than other areas. Recently literature reported that the cancer
      rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer
      prevalence probably has 10% in the nodular goiter.

      The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration
      cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to
      have special training cytological pathology doctor. Therefore, if we can have simple fast
      screening tool and can make up this insufficiency, then we can achieved the fast diagnosis,
      rapid processing, the promotion diagnosis and treatment quality and promotes the survival
      percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the
      simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early
      diagnosis & management this disease.

      This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC
      and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey
      and analysis.
observational model: Other
time perspective: Retrospective
measure: Accuracy with (TP+TN)/(TP+TN+FP+TN)
time frame: Jun 2018
measure: Sensitivity with TP/(TP+FN)
time frame: Jun 2018
measure: Specificity with TN/(TN+FP)
time frame: Jun 2018
measure: Positive predictive value (PPV) with TP/(TP+FP)
time frame: Jun 2018
measure: Negative predictive value (NPV) with TN/(TN+FN)
time frame: Jun 2018
arm group label: Subjects with nodular goiter
description: Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH. Total enrolled subject about 2000. These subjects were confirmed by pathology. Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients. Gray scale ultrasonography was routinely performed in every subject. Color Doppler ultrasonography for blood flow and thyroid fine needle aspiration was not absolute done in routine procedure. All data at least was interpreted by 3 endocrinologists under the blind method. Each subject was analyzed under thyroid echogenicity, margin, calcification, inclusion, grooving change and size & ratio size of tall and transverse.
intervention type: Diagnostic Test
intervention name: Thyroid ultrasonography
description: Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients.
arm group label: Subjects with nodular goiter
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: China Medical University Hospital
investigator full name: Chwen-Tzuei Chang
investigator title: Consultant
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: No