<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/NCT02226224</url>
  </required_header>
  <id_info>
    <org_study_id>EC1001</org_study_id>
    <nct_id>NCT02226224</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro</brief_title>
  <official_title>Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In our era of personalized treatment, both the prognosis and the choice of therapy for upper&#xD;
      GI malignancies depend on the staging before any treatment. Most experts recommend EUS&#xD;
      (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in&#xD;
      clinical practice varies in different centers according to the published data. Neither the&#xD;
      discrepancy between EUS and histological findings nor the variation between centers well&#xD;
      explained. So the investigators designed this prospective study. In the present study, the&#xD;
      investigators performed EUS on the resected specimen after surgery before fixation in&#xD;
      formalin, evaluated the invasion of the GI wall, and marked the deepest location with&#xD;
      sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy&#xD;
      between EUS and histologic findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - EUS Examination After the surgery, the specimen is filled with 0.9%NS (normal saline )&#xD;
      without cut open，and put into a container filled with 0.9%NS before fixation in formalin. EUS&#xD;
      will be performed on the resected specimen.The endoscopy move from the distal to proximal&#xD;
      side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark&#xD;
      the deepest point with sutures under the EUS guided. The images were stored .&#xD;
&#xD;
      EUS images the are reviewed by two endoscopists. They are asked to stage the tumor according&#xD;
      to the AJCC(American Joint Committee on Cancer) staging system (7th edition) , assign a level&#xD;
      of confidence to the staging, and score the quality of the EUS image .&#xD;
&#xD;
        -  Histologic Preparations and Examination Carcinoma invasion into each layer of the&#xD;
           gastric wall is diagnosed by an experienced pathologist (L.ZW) who is unaware of the&#xD;
           findings of the EUS imaging. The marked section will be assessed separately.&#xD;
&#xD;
        -  Data analysis The diagnosis between the pathologic findings and EUS prediction will be&#xD;
           compared. Whether the marked point was the deepest in pathologic findings is recorded.&#xD;
           And the histological section and the EUS image of the marked point is compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the consistency between EUS and pathologic determination of tumor depth</measure>
    <time_frame>1 month （after careful examination by 2 pathologists）</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Gastrointestinal Neoplasms</condition>
  <arm_group>
    <arm_group_label>early gastric cancer</arm_group_label>
    <description>EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Locally Advanced Gastric Cancer</arm_group_label>
    <description>EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>early esophagus cancer</arm_group_label>
    <description>EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>locally advanced esophagus cancer</arm_group_label>
    <description>EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with locally advanced upper GI carcinoma receive surgery as first treatment no&#xD;
        previous surgery involved the upper GI tract&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with upper GI carcinoma&#xD;
&#xD;
          -  Receive surgery as first treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgery involved the upper GI tract&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Yan, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Yan, Doctor</last_name>
    <phone>861088196168</phone>
    <email>dr.yan@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Yan, Doctor</last_name>
      <phone>861088196168</phone>
      <email>dr.yan@outlook.com</email>
    </contact>
    <investigator>
      <last_name>Yan Yan, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>July 17, 2017</last_update_submitted>
  <last_update_submitted_qc>July 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Yan Yan</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>gastrointestinal neoplasms</keyword>
  <keyword>endosonography</keyword>
  <keyword>in vitro</keyword>
  <keyword>Staging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</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/NCT02226224
org study id: EC1001
nct id: NCT02226224
lead sponsor: 
has dmc: No
In our era of personalized treatment, both the prognosis and the choice of therapy for upper
      GI malignancies depend on the staging before any treatment. Most experts recommend EUS
      (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in
      clinical practice varies in different centers according to the published data. Neither the
      discrepancy between EUS and histological findings nor the variation between centers well
      explained. So the investigators designed this prospective study. In the present study, the
      investigators performed EUS on the resected specimen after surgery before fixation in
      formalin, evaluated the invasion of the GI wall, and marked the deepest location with
      sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy
      between EUS and histologic findings.
- EUS Examination After the surgery, the specimen is filled with 0.9%NS (normal saline )
      without cut open，and put into a container filled with 0.9%NS before fixation in formalin. EUS
      will be performed on the resected specimen.The endoscopy move from the distal to proximal
      side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark
      the deepest point with sutures under the EUS guided. The images were stored .

      EUS images the are reviewed by two endoscopists. They are asked to stage the tumor according
      to the AJCC(American Joint Committee on Cancer) staging system (7th edition) , assign a level
      of confidence to the staging, and score the quality of the EUS image .

        -  Histologic Preparations and Examination Carcinoma invasion into each layer of the
           gastric wall is diagnosed by an experienced pathologist (L.ZW) who is unaware of the
           findings of the EUS imaging. The marked section will be assessed separately.

        -  Data analysis The diagnosis between the pathologic findings and EUS prediction will be
           compared. Whether the marked point was the deepest in pathologic findings is recorded.
           And the histological section and the EUS image of the marked point is compared.
observational model: Cohort
time perspective: Prospective
measure: the consistency between EUS and pathologic determination of tumor depth
time frame: 1 month （after careful examination by 2 pathologists）
arm group label: early gastric cancer
description: EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
arm group label: Locally Advanced Gastric Cancer
description: EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
arm group label: early esophagus cancer
description: EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
arm group label: locally advanced esophagus cancer
description: EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yan Yan, Doctor
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Yan Yan, Doctor
phone: 861088196168
email: dr.yan@outlook.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Yan Yan
investigator title: Attending physician
mesh term: Gastrointestinal Neoplasms
mesh term: Digestive System Neoplasms