<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/NCT04440605</url>
  </required_header>
  <id_info>
    <org_study_id>2019YJZ55</org_study_id>
    <nct_id>NCT04440605</nct_id>
  </id_info>
  <brief_title>A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis</brief_title>
  <official_title>A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weifang People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Province Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Province Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Qingdao University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qingdao Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Qinghai University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhongshan Hospital Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking 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>
      With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the&#xD;
      preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the&#xD;
      adjuvant therapy.&#xD;
&#xD;
      At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially&#xD;
      between eastern and western countries. According to the updated Japanese gastric cancer&#xD;
      treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure&#xD;
      for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy&#xD;
      accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall&#xD;
      precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively&#xD;
      account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment&#xD;
      comparing to patients with other cT stages.&#xD;
&#xD;
      Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM&#xD;
      staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM)&#xD;
      staging according to histopathologically examination. By analyzing the accordance between the&#xD;
      cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china,&#xD;
      verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning&#xD;
      the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the&#xD;
      scope of beneficiaries for neoadjuvant chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      I. Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx)&#xD;
      (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid&#xD;
      overtreatment, by examining the rate of pI rate in different diagnostic criterion groups,&#xD;
      including cIII, TxNy(x+y&gt;4), cN1-3, cT3-4.&#xD;
&#xD;
      III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic&#xD;
      accuracy.&#xD;
&#xD;
      Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII,&#xD;
      cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the&#xD;
      pathological stages is given following surgery.&#xD;
&#xD;
      The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups&#xD;
      to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups&#xD;
      to assess the suitable NAC criteria.&#xD;
&#xD;
      PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Diagnostic Accuracy of cIII</measure>
    <time_frame>1.5 years</time_frame>
    <description>Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Accuracy of cTxNy</measure>
    <time_frame>1.5 years</time_frame>
    <description>Proportion of pathological stage I among clinical TxNy(x+y&gt;4) stage diagnosis patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Accuracy of cN+</measure>
    <time_frame>1.5 years</time_frame>
    <description>Proportion of pathological stage I among clinical N1-3 stage diagnosis patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Accuracy of cT3/4</measure>
    <time_frame>1.5 years</time_frame>
    <description>Proportion of pathological stage I among clinical T3-4 stage diagnosis patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Accuracy of cTN</measure>
    <time_frame>1.5 years</time_frame>
    <description>The concordance rate for clinical staging</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">968</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Gastric Cancer Stage</condition>
  <condition>CT</condition>
  <condition>Neoadjuvant Therapy</condition>
  <arm_group>
    <arm_group_label>cI</arm_group_label>
    <description>clincal TNM stage I</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cII</arm_group_label>
    <description>clinical TNM stage II</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cIII</arm_group_label>
    <description>clinical TNM stage III</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preoperative staging--D2 gastrectomy--Postoperative staging</intervention_name>
    <description>Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy</description>
    <arm_group_label>cI</arm_group_label>
    <arm_group_label>cII</arm_group_label>
    <arm_group_label>cIII</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Adenocarcinoma tissue sample retrieved by endoscopic and sugical methods&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with endoscopically biopsy-proven adenocarcinoma of the stomach and with&#xD;
        contrast-enhanced CT cI-III diagnosis prior to surgery will receive treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological prove of adenocarcinoma of the stomach by endoscopy&#xD;
&#xD;
          -  Preoperative imaging data by contrast-enhanced CT and clinical TNM stages were given&#xD;
&#xD;
          -  No evidence of stage IV disease&#xD;
&#xD;
          -  No previous gastrectomy or preoperative treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Discovery of distant metastasis (stage IV) during surgery&#xD;
&#xD;
          -  Number of retrieved lymph node less than 15&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Cancer Hospital &amp; Institute</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ziyu Li, M.D.</last_name>
      <phone>86-010-8819-6606</phone>
      <email>ziyu_li@hsc.pku.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Ziyu Li, M.D., Ph.D</last_name>
      <phone>86-010-8819-6605</phone>
      <email>ziyu_li@hsc.pku.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Jiafu Ji, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ziyu Li, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fei Shan, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiangji Ying, M.P.H</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chao Gao, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>301 Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiaohui Du, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>302 Military Hospital of China</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Feng Liang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jun Zhang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gang Zhao, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ning Ning, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Peoples Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bin Liang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhaohui Zheng, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Tumor Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Weidong Zang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jun You, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xingfeng Qiu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yong Li, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wei Wang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jiang Yu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wu Song, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qun Zhao, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Heilongjiang Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kuan Wang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kaixiong Tao, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu People's Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zekuan Xu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhengrong Li, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Daguang Wang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jiaming Zhu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital-Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xinsheng Zhang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qinghai University Affiliated Hospital</name>
      <address>
        <city>Xining</city>
        <state>Qinghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Su Yan, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lin Fan, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Changqing Jing, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hong Qi, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhaojian Niu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Weifang People's Hospital</name>
      <address>
        <city>Weifang</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jianjun Qu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fudan University Cancer center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hua Huang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lu Zang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gang Zhao, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fenglin Liu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Tumour Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qingxing Huang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chendu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kun Yang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jingyu Deng, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Weihua Fu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wenbin Zhang, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Fukagawa T, Katai H, Mizusawa J, Nakamura K, Sano T, Terashima M, Ito S, Yoshikawa T, Fukushima N, Kawachi Y, Kinoshita T, Kimura Y, Yabusaki H, Nishida Y, Iwasaki Y, Lee SW, Yasuda T, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. A prospective multi-institutional validity study to evaluate the accuracy of clinical diagnosis of pathological stage III gastric cancer (JCOG1302A). Gastric Cancer. 2018 Jan;21(1):68-73. doi: 10.1007/s10120-017-0701-1. Epub 2017 Feb 13.</citation>
    <PMID>28194522</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Ziyu Li, MD</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>Clinical TNM staging</keyword>
  <keyword>Adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT04440605
org study id: 2019YJZ55
nct id: NCT04440605
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is fda regulated drug: No
is fda regulated device: No
With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the
      preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the
      adjuvant therapy.

      At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially
      between eastern and western countries. According to the updated Japanese gastric cancer
      treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure
      for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy
      accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall
      precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively
      account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment
      comparing to patients with other cT stages.

      Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM
      staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM)
      staging according to histopathologically examination. By analyzing the accordance between the
      cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china,
      verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning
      the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the
      scope of beneficiaries for neoadjuvant chemotherapy.
OBJECTIVES:

      I. Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx)
      (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid
      overtreatment, by examining the rate of pI rate in different diagnostic criterion groups,
      including cIII, TxNy(x+y>4), cN1-3, cT3-4.

      III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.

      OUTLINE:

      This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic
      accuracy.

      Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII,
      cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the
      pathological stages is given following surgery.

      The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups
      to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups
      to assess the suitable NAC criteria.

      PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic Accuracy of cIII
time frame: 1.5 years
description: Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients
measure: Diagnostic Accuracy of cTxNy
time frame: 1.5 years
description: Proportion of pathological stage I among clinical TxNy(x+y>4) stage diagnosis patients
measure: Diagnostic Accuracy of cN+
time frame: 1.5 years
description: Proportion of pathological stage I among clinical N1-3 stage diagnosis patients
measure: Diagnostic Accuracy of cT3/4
time frame: 1.5 years
description: Proportion of pathological stage I among clinical T3-4 stage diagnosis patients
measure: Diagnostic Accuracy of cTN
time frame: 1.5 years
description: The concordance rate for clinical staging
arm group label: cI
description: clincal TNM stage I
arm group label: cII
description: clinical TNM stage II
arm group label: cIII
description: clinical TNM stage III
intervention type: Procedure
intervention name: Preoperative staging--D2 gastrectomy--Postoperative staging
description: Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy
arm group label: cI
arm group label: cII
arm group label: cIII
Adenocarcinoma tissue sample retrieved by endoscopic and sugical methods
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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status: Recruiting
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country: China
citation: Fukagawa T, Katai H, Mizusawa J, Nakamura K, Sano T, Terashima M, Ito S, Yoshikawa T, Fukushima N, Kawachi Y, Kinoshita T, Kimura Y, Yabusaki H, Nishida Y, Iwasaki Y, Lee SW, Yasuda T, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. A prospective multi-institutional validity study to evaluate the accuracy of clinical diagnosis of pathological stage III gastric cancer (JCOG1302A). Gastric Cancer. 2018 Jan;21(1):68-73. doi: 10.1007/s10120-017-0701-1. Epub 2017 Feb 13.
PMID: 28194522
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Ziyu Li, MD
investigator title: M.D., Ph.D.
mesh term: Stomach Neoplasms