<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/NCT03810274</url>
  </required_header>
  <id_info>
    <org_study_id>XQonc-012</org_study_id>
    <nct_id>NCT03810274</nct_id>
  </id_info>
  <brief_title>3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal Carcinoma</brief_title>
  <official_title>3DV+TPS Software Outlines the Outline of Radiotherapy for Nasopharyngeal Carcinoma Center Comparison Study Clinical Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinqiao Hospital of Chongqing</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>
      Comparing the accuracy and speed of 3DV+TPS software with imported TPS and domestic TPS to&#xD;
      outline the contours of crisis organs, it is proved that 3DV+TPS has superiority compared&#xD;
      with domestic TPS, and it has non-inferiority compared with imported TPS, indicating that the&#xD;
      software can improve contour sketching accuracy. And speed, reduce the burden on doctors,&#xD;
      improve medical efficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparing the accuracy and speed difference between 3DV+TPS software and imported TPS and&#xD;
      domestic TPS to outline the contours of crisis organs, the selected organs are: bilateral&#xD;
      eyeballs, bilateral crystals, bilateral optic nerves, bilateral parotid glands, oral cavity,&#xD;
      spinal cord, brainstem, The brain has a total of 12 organs; verify that 3DV+TPS is superior&#xD;
      to domestic TPS, and has non-inferiority compared with imported TPS, Ming software can&#xD;
      improve the accuracy and speed of contour sketching, reduce the burden on doctors, and&#xD;
      improve medical efficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Sketching accuracy</measure>
    <time_frame>one year</time_frame>
    <description>Define ΔV as a percentage of the total volume of the gold standard;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sketch speed</measure>
    <time_frame>one year</time_frame>
    <description>Use the stopwatch to record the total time used to draw down 12 organs, to start sketching as the starting point of the time, and to finish the saving of the data.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Radiotherapy</condition>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>3DV+TPS</arm_group_label>
    <description>This experiment included a total of 300 patients with nasopharyngeal carcinoma, using 3DV + TPS software and imported TPS, domestic TPS, these three sets of TPS delineate bilateral crystal, bilateral optic nerve, bilateral eyeball, bilateral parotid gland, oral cavity, spinal cord There are 12 organs in the brainstem and brain, and the accuracy and speed of the 3 sets of TPS sketches are compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3DV+TPS；VARIAN TPS；FonicsPlan</intervention_name>
    <arm_group_label>3DV+TPS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 7 different grade hospital radiotherapy centers have received radiotherapy for&#xD;
        patients with nasopharyngeal carcinoma Case information, based on inclusion and exclusion&#xD;
        criteria, a total of 300 cases were screened. Among them, Xinqiao Hospital collected 180&#xD;
        cases, He collected 20 cases in 20 hospitals, totaling 200 cases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. It is diagnosed as nasopharyngeal carcinoma by histopathological examination, and&#xD;
             there is no tumor invasion in the organs that need to be assessed;&#xD;
&#xD;
          2. Age 18-70 years old;&#xD;
&#xD;
          3. There is nasopharynx localization enhanced CT, nasopharynx enhanced MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient information is incomplete; no age, gender, MRI, height, radiotherapy location&#xD;
             CT;&#xD;
&#xD;
          2. The organs at risk that need to be assessed are invaded by the tumor;&#xD;
&#xD;
          3. Any reason cannot be combined with the research or the researcher believes that it is&#xD;
             not suitable for inclusion in this test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xinqiao Hospital of Chongqing</name>
      <address>
        <city>Chongqing</city>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinqiao Hospital of Chongqing</investigator_affiliation>
    <investigator_full_name>Jianguo Sun</investigator_full_name>
    <investigator_title>Deputy Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</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/NCT03810274
org study id: XQonc-012
nct id: NCT03810274
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Comparing the accuracy and speed of 3DV+TPS software with imported TPS and domestic TPS to
      outline the contours of crisis organs, it is proved that 3DV+TPS has superiority compared
      with domestic TPS, and it has non-inferiority compared with imported TPS, indicating that the
      software can improve contour sketching accuracy. And speed, reduce the burden on doctors,
      improve medical efficiency.
Comparing the accuracy and speed difference between 3DV+TPS software and imported TPS and
      domestic TPS to outline the contours of crisis organs, the selected organs are: bilateral
      eyeballs, bilateral crystals, bilateral optic nerves, bilateral parotid glands, oral cavity,
      spinal cord, brainstem, The brain has a total of 12 organs; verify that 3DV+TPS is superior
      to domestic TPS, and has non-inferiority compared with imported TPS, Ming software can
      improve the accuracy and speed of contour sketching, reduce the burden on doctors, and
      improve medical efficiency.
observational model: Cohort
time perspective: Retrospective
measure: Sketching accuracy
time frame: one year
description: Define ΔV as a percentage of the total volume of the gold standard;
measure: Sketch speed
time frame: one year
description: Use the stopwatch to record the total time used to draw down 12 organs, to start sketching as the starting point of the time, and to finish the saving of the data.
arm group label: 3DV+TPS
description: This experiment included a total of 300 patients with nasopharyngeal carcinoma, using 3DV + TPS software and imported TPS, domestic TPS, these three sets of TPS delineate bilateral crystal, bilateral optic nerve, bilateral eyeball, bilateral parotid gland, oral cavity, spinal cord There are 12 organs in the brainstem and brain, and the accuracy and speed of the 3 sets of TPS sketches are compared.
intervention type: Device
intervention name: 3DV+TPS；VARIAN TPS；FonicsPlan
arm group label: 3DV+TPS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinqiao Hospital of Chongqing
investigator full name: Jianguo Sun
investigator title: Deputy Director
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma