<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/NCT03778710</url>
  </required_header>
  <id_info>
    <org_study_id>2018/633</org_study_id>
    <nct_id>NCT03778710</nct_id>
  </id_info>
  <brief_title>Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection</brief_title>
  <official_title>Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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>
      D2 gastrectomy is standard treatment of early gastric cancer in Japan but in other countries&#xD;
      there is still some discord, especially in Europe and North America. Although the quantity of&#xD;
      metastasis cancer in lymph node defines survival regardless of which country the patient is&#xD;
      treated, the total number of lymph nodes harvested is an important factor to predict accurate&#xD;
      staging and/or D2 gastrectomy. Both of the number total lymph nodes and the metastasis lymph&#xD;
      node status in gastric cancer are important factors to decide each prognosis. This study&#xD;
      evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph&#xD;
      node ratio (LNR) status to determine the recurrence rate after curative resection of gastric&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective chart review was made of all patients who presented with gastric cancer after&#xD;
      curative surgery resection from January 1, 1995 to December 31, 2016 in Ramathibodi&#xD;
      Hospital.Data of metastasis node by lymph node ratio (LNR) were evaluated. The total of lymph&#xD;
      node less than 15 and more than 15 were evaluated. The Kaplan-Meier curve estimates&#xD;
      recurrence survival (Log-rank test). The p-value &lt; 0.05 is statistically significant.&#xD;
&#xD;
      OBJECTIVE :&#xD;
&#xD;
      The outcome of this study was evaluated lymph node ratio (LNR) status that determined by the&#xD;
      ratio of total lymph node metastasis and the total lymph node which retrieved after performed&#xD;
      the curative surgery and lymphadenectomy of gastric cancer. The correlation of LNR and&#xD;
      prognosis of recurrence and survival of gastric cancer patients were evaluated and reported&#xD;
      in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">February 20, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</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>The correlation of lymph node ratio and survival of gastric cancer patients</measure>
    <time_frame>5 year</time_frame>
    <description>correlation of lymph node ratio and survival of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The correlation of lymph node ratio and prognosis of recurrence of gastric cancer patients</measure>
    <time_frame>5 year</time_frame>
    <description>correlation of lymph node ratio and recurrence of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients</measure>
    <time_frame>5 year</time_frame>
    <description>correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients..lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.</description>
  </secondary_outcome>
  <enrollment type="Actual">155</enrollment>
  <condition>Gastric Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who presented with gastric cancer after curative surgery resection from&#xD;
        January 1, 1995 to December 31, 2016 in Ramathibodi Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gastric cancer after curative surgery resection&#xD;
&#xD;
          -  No received neoadjuvant therapy&#xD;
&#xD;
          -  Patients have tissues confirmed by Pathology&#xD;
&#xD;
          -  Staging used esophagogastroduodenoscopy (EGD) or imaging, including ultrasonography,&#xD;
             Computer Tomography (CT) or Magnetic Resonance Imaging (MRI&#xD;
&#xD;
          -  Surgery was performed for curative intent and D2 lymphadenectomy and according from&#xD;
             Japanese guideline for gastric cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastasis during surgery&#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>Chairat Supsamutchai, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chairat Supsamutchai</name>
      <address>
        <city>Bangkok</city>
        <state>Bankok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 24, 2019</last_update_submitted>
  <last_update_submitted_qc>March 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lymph node metastasis, Gastric cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03778710
org study id: 2018/633
nct id: NCT03778710
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
D2 gastrectomy is standard treatment of early gastric cancer in Japan but in other countries
      there is still some discord, especially in Europe and North America. Although the quantity of
      metastasis cancer in lymph node defines survival regardless of which country the patient is
      treated, the total number of lymph nodes harvested is an important factor to predict accurate
      staging and/or D2 gastrectomy. Both of the number total lymph nodes and the metastasis lymph
      node status in gastric cancer are important factors to decide each prognosis. This study
      evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph
      node ratio (LNR) status to determine the recurrence rate after curative resection of gastric
A retrospective chart review was made of all patients who presented with gastric cancer after
      curative surgery resection from January 1, 1995 to December 31, 2016 in Ramathibodi
      Hospital.Data of metastasis node by lymph node ratio (LNR) were evaluated. The total of lymph
      node less than 15 and more than 15 were evaluated. The Kaplan-Meier curve estimates
      recurrence survival (Log-rank test). The p-value < 0.05 is statistically significant.

      OBJECTIVE :

      The outcome of this study was evaluated lymph node ratio (LNR) status that determined by the
      ratio of total lymph node metastasis and the total lymph node which retrieved after performed
      the curative surgery and lymphadenectomy of gastric cancer. The correlation of LNR and
      prognosis of recurrence and survival of gastric cancer patients were evaluated and reported
      in this study.
observational model: Cohort
time perspective: Retrospective
measure: The correlation of lymph node ratio and survival of gastric cancer patients
time frame: 5 year
description: correlation of lymph node ratio and survival of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.
measure: The correlation of lymph node ratio and prognosis of recurrence of gastric cancer patients
time frame: 5 year
description: correlation of lymph node ratio and recurrence of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.
measure: The correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients
time frame: 5 year
description: correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients..lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chairat Supsamutchai, MD
role: Study Chair
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Recurrence
sharing ipd: No