<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/NCT03794193</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-1653</org_study_id>
    <nct_id>NCT03794193</nct_id>
  </id_info>
  <brief_title>The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer</brief_title>
  <official_title>The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      To explore the effect of unfavorable histological features on the clinical outcomes of&#xD;
      patients receiving radical resection of colon cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">December 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>3-year Disease-free Survival</measure>
    <time_frame>Within 3 years after surgery</time_frame>
    <description>The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3-year Over-all Survival</measure>
    <time_frame>Within 3 years after surgery</time_frame>
    <description>The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication rate</measure>
    <time_frame>Within 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality rate</measure>
    <time_frame>Within 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence rate</measure>
    <time_frame>Within 3 years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant organ metastasis rate</measure>
    <time_frame>Within 3 years after surgery</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1367</enrollment>
  <condition>Colon Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical resection of colon cancer</intervention_name>
    <description>The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.</description>
    <other_name>Chemotherapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Colon cancer patients with or without unfavorable histological features&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18-100 years old;&#xD;
&#xD;
          2. Postoperative pathology confirmed colon adenocarcinoma;&#xD;
&#xD;
          3. The tumor is located from the cecum to the sigmoid colon;&#xD;
&#xD;
          4. No distant organ metastasis;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Simultaneous or metachronous multiple primary colorectal cancer;&#xD;
&#xD;
          2. History of previous malignant tumors (except for completely cured cervical carcinoma&#xD;
             in situ or basal cell carcinoma or squamous epithelial skin cancer)&#xD;
&#xD;
          3. local excision procedure;&#xD;
&#xD;
          4. palliative resection (R2 resection);&#xD;
&#xD;
          5. pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Xiao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</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>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual participant data can be shared with all researchers involved in the study.</ipd_description>
  </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/NCT03794193
org study id: ZS-1653
nct id: NCT03794193
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To explore the effect of unfavorable histological features on the clinical outcomes of
      patients receiving radical resection of colon cancer.
observational model: Cohort
time perspective: Retrospective
measure: 3-year Disease-free Survival
time frame: Within 3 years after surgery
description: The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.
measure: 3-year Over-all Survival
time frame: Within 3 years after surgery
description: The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.
measure: Postoperative complication rate
time frame: Within 30 days after surgery
measure: Postoperative mortality rate
time frame: Within 30 days after surgery
measure: Local recurrence rate
time frame: Within 3 years after surgery
measure: Distant organ metastasis rate
time frame: Within 3 years after surgery
intervention type: Procedure
intervention name: Radical resection of colon cancer
description: The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.
other name: Chemotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yi Xiao, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: Undecided
ipd description: Individual participant data can be shared with all researchers involved in the study.