<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/NCT03813173</url>
  </required_header>
  <id_info>
    <org_study_id>ZhejiangU20190116</org_study_id>
    <nct_id>NCT03813173</nct_id>
  </id_info>
  <brief_title>Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma</brief_title>
  <official_title>Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is divided into three stages. In the first stage, the investigators try to explore&#xD;
      the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate&#xD;
      the &quot;clinical imaging standard of cN0PTC&quot;, and randomly enroll 2000 patients under the&#xD;
      premise of meeting the standard to establish the &quot;predictive model of cN0-pN+PTC&quot;.&#xD;
&#xD;
      In the second stage, 2000 patients will be enrolled to test and improve the evaluation&#xD;
      efficiency of &quot;cN0-pN+PTC prediction model&quot;.&#xD;
&#xD;
      In the third stage, 2 000 patients without lymph node metastasis assessed by &quot;cNo-pN+ PTC&#xD;
      prediction model&quot; will be randomly divided into experimental group and control group. The&#xD;
      experimental group will be treated with pCND, while the experimental group will be treated&#xD;
      without pCND. The central lymph node metastasis probability, the number and size of&#xD;
      metastatic lymph nodes in the control group will be observed after operation. The two groups&#xD;
      will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further&#xD;
      evaluate the &quot;cN0-pN+PTC prediction model&quot; scientifically.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2020</start_date>
  <completion_date type="Anticipated">December 2040</completion_date>
  <primary_completion_date type="Anticipated">December 2040</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of thyroid cancer</measure>
    <time_frame>Participants will be followed from the operation to 20 year (maximum)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Lymph Node Metastases</condition>
  <arm_group>
    <arm_group_label>central cervical dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>non central cervical dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lymph node dissection</intervention_name>
    <description>The patient was operated under general anesthesia with cervical hyper extension. The affected side or bilateral glandular lobes were resected routinely, which was confirmed as PTC by frozen section. Then one or both central lymph node dissection were separately packed and sent for examination. Scope of lymph node dissection in central carotid region: hyoid bone at the upper border, anonymous artery at the lower border, bilateral common carotid artery at the inner edge, shallow from the superficial layer of deep cervical fascia, deep to the deep layer of deep cervical fascia (anterior fascia). The right recurrent laryngeal nerve (RLN) passes through the central area of the right neck and should be specially protected.</description>
    <arm_group_label>central cervical dissection</arm_group_label>
    <arm_group_label>non central cervical dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase I and II:&#xD;
&#xD;
               1. aged 18 to 80 years old;&#xD;
&#xD;
               2. the primary treatment of patients with unilateral or bilateral PTC;&#xD;
&#xD;
               3. ultrasound showed that the tumor was localized in the thyroid gland, and the&#xD;
                  maximum diameter of each lesion was less than 4cm;&#xD;
&#xD;
               4. ultrasonography of cervical VI lymph nodes: the shortest diameter &lt; 4 mm, no&#xD;
                  calcification, no cystic change, no local or global echo enhancement;&#xD;
&#xD;
               5. CT scan of cervical VI lymph nodes: the shortest diameter &lt; 4 mm, no&#xD;
                  calcification, no cystic change, no enhancement (CT value 40HU or not higher than&#xD;
                  banded muscle level), no cluster distribution;&#xD;
&#xD;
               6. patients will voluntarily enter the study after informed consent;&#xD;
&#xD;
        Phase III:&#xD;
&#xD;
          1. aged from 18 to 80 years old;&#xD;
&#xD;
          2. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum&#xD;
             diameter of each lesion was less than 4cm;&#xD;
&#xD;
          3. Unilateral or bilateral PTC without lymph node metastasis assessed by &quot;cNo-pN+ PTC&#xD;
             prediction model&quot;;&#xD;
&#xD;
          4. patients will voluntarily enter the study after informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) patients refused to participate in the study; (2) non first operation patients;&#xD;
             (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5)&#xD;
             history of neck trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Luo Dingcun</investigator_full_name>
    <investigator_title>vice president of hospital</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>Lymphatic Metastasis</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</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/NCT03813173
org study id: ZhejiangU20190116
nct id: NCT03813173
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is divided into three stages. In the first stage, the investigators try to explore
      the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate
      the "clinical imaging standard of cN0PTC", and randomly enroll 2000 patients under the
      premise of meeting the standard to establish the "predictive model of cN0-pN+PTC".

      In the second stage, 2000 patients will be enrolled to test and improve the evaluation
      efficiency of "cN0-pN+PTC prediction model".

      In the third stage, 2 000 patients without lymph node metastasis assessed by "cNo-pN+ PTC
      prediction model" will be randomly divided into experimental group and control group. The
      experimental group will be treated with pCND, while the experimental group will be treated
      without pCND. The central lymph node metastasis probability, the number and size of
      metastatic lymph nodes in the control group will be observed after operation. The two groups
      will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further
      evaluate the "cN0-pN+PTC prediction model" scientifically.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence of thyroid cancer
time frame: Participants will be followed from the operation to 20 year (maximum)
arm group label: central cervical dissection
arm group type: Active Comparator
arm group label: non central cervical dissection
arm group type: Experimental
intervention type: Procedure
intervention name: lymph node dissection
description: The patient was operated under general anesthesia with cervical hyper extension. The affected side or bilateral glandular lobes were resected routinely, which was confirmed as PTC by frozen section. Then one or both central lymph node dissection were separately packed and sent for examination. Scope of lymph node dissection in central carotid region: hyoid bone at the upper border, anonymous artery at the lower border, bilateral common carotid artery at the inner edge, shallow from the superficial layer of deep cervical fascia, deep to the deep layer of deep cervical fascia (anterior fascia). The right recurrent laryngeal nerve (RLN) passes through the central area of the right neck and should be specially protected.
arm group label: central cervical dissection
arm group label: non central cervical dissection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Luo Dingcun
investigator title: vice president of hospital
mesh term: Thyroid Neoplasms
mesh term: Lymphatic Metastasis
mesh term: Thyroid Cancer, Papillary