<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/NCT04439812</url>
  </required_header>
  <id_info>
    <org_study_id>186/20</org_study_id>
    <nct_id>NCT04439812</nct_id>
  </id_info>
  <brief_title>Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer</brief_title>
  <official_title>Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Ramon y Cajal</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It&#xD;
      has been suggested that positive surgical margins is an adverse prognosis factor, with a&#xD;
      higher local recurrence and worse overall survival (OS). However, the management of these&#xD;
      patients remains unclear.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">December 31, 2018</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>evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC</measure>
    <time_frame>8 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.</measure>
    <time_frame>8 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">267</enrollment>
  <condition>Stomach Neoplasms</condition>
  <arm_group>
    <arm_group_label>R=0</arm_group_label>
    <description>Patients without positive margins after gastrectomy for gastric cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R=1</arm_group_label>
    <description>Patients with positive margins after gastrectomy for gastric cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.</description>
    <arm_group_label>R=0</arm_group_label>
    <arm_group_label>R=1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all consecutive patients who underwent an oncological gastrectomy due to gastric cancer,&#xD;
        between January 2010 and December 2018 at Ramon y Cajal University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all consecutive patients who underwent an oncological gastrectomy due to gastric&#xD;
             cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  distant disease (including patients with positive cytology), early postoperative&#xD;
             mortality (within 30 days after surgery) and follow-up data not available. Resections&#xD;
             in patients with palliative intent were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Priego, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Ramón y Cajal</affiliation>
  </overall_official>
  <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>Hospital Universitario Ramon y Cajal</investigator_affiliation>
    <investigator_full_name>Pablo Priego</investigator_full_name>
    <investigator_title>Consultant surgeon MD, PhD. Associate Profesor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>gastrectomy</keyword>
  <keyword>R1</keyword>
  <keyword>positive margins</keyword>
  <keyword>recurrence</keyword>
  <keyword>overall survival</keyword>
  <keyword>prognosis</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/NCT04439812
org study id: 186/20
nct id: NCT04439812
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It
      has been suggested that positive surgical margins is an adverse prognosis factor, with a
      higher local recurrence and worse overall survival (OS). However, the management of these
      patients remains unclear.
observational model: Cohort
time perspective: Retrospective
measure: evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC
time frame: 8 years
measure: The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
time frame: 8 years
arm group label: R=0
description: Patients without positive margins after gastrectomy for gastric cancer
arm group label: R=1
description: Patients with positive margins after gastrectomy for gastric cancer
intervention type: Other
intervention name: Observation
description: The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
arm group label: R=0
arm group label: R=1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pablo Priego, MD, PhD
role: Principal Investigator
affiliation: Hospital Universitario Ramón y Cajal
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Ramon y Cajal
investigator full name: Pablo Priego
investigator title: Consultant surgeon MD, PhD. Associate Profesor of Surgery
mesh term: Stomach Neoplasms
mesh term: Recurrence
sharing ipd: No