xml: <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/NCT06023966</url>
    </required_header>
    <id_info>
      <org_study_id>DJY003</org_study_id>
      <nct_id>NCT06023966</nct_id>
    </id_info>
    <brief_title>A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery</brief_title>
    <official_title>A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Cancer Institute and 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>
        A previous study of investigators established a risk scoring model for the occurrence of&#xD;
        postoperative hepatic metastases in patients who underwent curative gastrectomy directly&#xD;
        without neoadjuvant therapy. In order to further validate the clinical applicability of&#xD;
        abovementioned model, investigators designed this prospective study, which also included&#xD;
        patients who received neoadjuvant therapy before surgery, with the aim of exploring the&#xD;
        applicability of the risk scoring model to this group of patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was a single-centre, prospective study. Prospectively collected data were used to&#xD;
        analyze the consistency between the actual outcomes of patients with or without hepatic&#xD;
        metastases after curative gastrectomy and the predicted outcomes of the risk scoring model,&#xD;
        in order to assess the clinical applicability of the model. In addition, analyses were&#xD;
        performed to compare the differences in the risk of hepatic metastasis and the time interval&#xD;
        of occurrence between patients who did not receive neoadjuvant therapy and those who received&#xD;
        neoadjuvant therapy, as well as between patients with different outcomes after receiving&#xD;
        neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2026</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>hepatic metastasis</measure>
      <time_frame>2 years after curative surgery</time_frame>
      <description>Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>interval between the surgery and hepatic metastasis</measure>
      <time_frame>2 years after curative surgery</time_frame>
      <description>Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the interval between the gastrectomy and development of hepatic metastasis.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Predictive Cancer Model</condition>
    <condition>Hepatic Metastasis</condition>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>with HMGC</arm_group_label>
      <description>patients with gastric cancer who developed hepatic metastasis after curative gastrectomy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>without HMGC</arm_group_label>
      <description>patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patietns who were diagnosed with gastric cancer pathologically and underwent curative&#xD;
          gastrectomy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Received curative gastrectomy (D2 lymph node dissection);&#xD;
  &#xD;
            2. Gastric cancer without distant organ metastasis, distant lymph node metastasis and&#xD;
               peritoneal implantation (M0) confirmed by postoperative pathology;&#xD;
  &#xD;
            3. No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis&#xD;
               and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic&#xD;
               tuberculosis, and no severe fatty liver disease before the curative surgery;&#xD;
  &#xD;
            4. No history of intraperitoneal chemotherapy;&#xD;
  &#xD;
            5. No other serious concomitant diseases with satisfactory organ function;&#xD;
  &#xD;
            6. No history of other malignant tumors;&#xD;
  &#xD;
            7. Comply with the protocol during the whole study period;&#xD;
  &#xD;
            8. Sign informed consent and permission of withdraw in the whole study period;&#xD;
  &#xD;
            9. Estimation the overall survival after surgery no less than 12 months;&#xD;
  &#xD;
           10. Consent to analysis of clinicopathological data and prognostic follow up;&#xD;
  &#xD;
           11. Karnofsky Performance Scores (KPS) more than 60.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell,&#xD;
               hepatoid adenocarcinoma or others);&#xD;
  &#xD;
            2. Gastro-esophageal junction cancer;&#xD;
  &#xD;
            3. Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within&#xD;
               12 months;&#xD;
  &#xD;
            4. Immunosuppressive therapists for organ transplantation;&#xD;
  &#xD;
            5. Seriously uncontrolled recurrent infection;&#xD;
  &#xD;
            6. History of other malignancies;&#xD;
  &#xD;
            7. No abilities of self-knowledge or mental disorders;&#xD;
  &#xD;
            8. Combination of other serious diseases;&#xD;
  &#xD;
            9. Concurrent participation in other clinical trials.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jingyu Deng, M.D.</last_name>
      <phone>+86-22-23340123</phone>
      <email>dengery@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cancer Hospital of Tianjin Medical University</name>
        <address>
          <city>Tianjin</city>
          <state>天津</state>
          <zip>300060</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jingyu Deng, M.D.</last_name>
        <email>Dengery@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023966
  org study id: DJY003
  nct id: NCT06023966
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A previous study of investigators established a risk scoring model for the occurrence of
        postoperative hepatic metastases in patients who underwent curative gastrectomy directly
        without neoadjuvant therapy. In order to further validate the clinical applicability of
        abovementioned model, investigators designed this prospective study, which also included
        patients who received neoadjuvant therapy before surgery, with the aim of exploring the
        applicability of the risk scoring model to this group of patients.
  The study was a single-centre, prospective study. Prospectively collected data were used to
        analyze the consistency between the actual outcomes of patients with or without hepatic
        metastases after curative gastrectomy and the predicted outcomes of the risk scoring model,
        in order to assess the clinical applicability of the model. In addition, analyses were
        performed to compare the differences in the risk of hepatic metastasis and the time interval
        of occurrence between patients who did not receive neoadjuvant therapy and those who received
        neoadjuvant therapy, as well as between patients with different outcomes after receiving
        neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).
  observational model: Cohort
  time perspective: Prospective
  measure: hepatic metastasis
  time frame: 2 years after curative surgery
  description: Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.
  measure: interval between the surgery and hepatic metastasis
  time frame: 2 years after curative surgery
  description: Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the interval between the gastrectomy and development of hepatic metastasis.
  arm group label: with HMGC
  description: patients with gastric cancer who developed hepatic metastasis after curative gastrectomy
  arm group label: without HMGC
  description: patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Jingyu Deng, M.D.
  phone: +86-22-23340123
  email: dengery@126.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasm Metastasis
  mesh term: Stomach Neoplasms
  sharing ipd: No