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/NCT06040021</url>
    </required_header>
    <id_info>
      <org_study_id>FDU-EOCRC</org_study_id>
      <nct_id>NCT06040021</nct_id>
    </id_info>
    <brief_title>Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer</brief_title>
    <official_title>Integrated Analysis of Multi-center Cohorts and Bulk RNA-sequencing Data Reveal Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan 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>
        The clinical and pathological features of early-onset colorectal cancer (EOCRC) differ from&#xD;
        those of late-onset colorectal cancer (LOCRC). Our research aims to thoroughly elucidate the&#xD;
        distinctions between them by analyzing clinical prognosis, metastatic patterns, gene&#xD;
        expression, and genomic mutation profiles. Our deliberation will uncover latent strategies&#xD;
        for personalized therapeutic of both EOCRC and LOCRC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2008</start_date>
    <completion_date type="Actual">June 30, 2023</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>OS</measure>
      <time_frame>5 years after intervention</time_frame>
      <description>overall survival</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">15244</enrollment>
    <condition>Early-onset Colorectal Cancer</condition>
    <condition>Late-onset Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>EOCRC</arm_group_label>
      <description>Patients aged&lt;50 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IOCRC</arm_group_label>
      <description>Patients aged between 50 to 70 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LOCRC</arm_group_label>
      <description>Patients aged between≥70 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standardized treatment</intervention_name>
      <description>Patients enrolled in these 2 cohorts all received standardized treatment of colorectal cancer.</description>
      <arm_group_label>EOCRC</arm_group_label>
      <arm_group_label>IOCRC</arm_group_label>
      <arm_group_label>LOCRC</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with colorectal cancer hospitalized in Fudan university Shanghai cancer center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The initial diagnosis of colonoscopy and pathology belongs to colorectal cancer;&#xD;
  &#xD;
            -  Patients should sign an informed consent form after fully understanding the purpose,&#xD;
               procedures and potential risks of the study, indicating their voluntary participation&#xD;
               in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with obvious local or systemic severe infection;&#xD;
  &#xD;
            -  Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;&#xD;
  &#xD;
            -  Have a systemic underlying disease that has not been controlled, or is unstable;&#xD;
  &#xD;
            -  Patients with poor physical fitness or serious other organic diseases who cannot&#xD;
               tolerate anesthesia and surgery;&#xD;
  &#xD;
            -  Women during pregnancy, perinatal and lactation;&#xD;
  &#xD;
            -  Patients with severe mental disorders (such as schizophrenia, bipolar disorder, etc.)&#xD;
               or patients who are mentally incapable or unable to understand the requirements for&#xD;
               participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>LI XIN-XIANG</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06040021
  org study id: FDU-EOCRC
  nct id: NCT06040021
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The clinical and pathological features of early-onset colorectal cancer (EOCRC) differ from
        those of late-onset colorectal cancer (LOCRC). Our research aims to thoroughly elucidate the
        distinctions between them by analyzing clinical prognosis, metastatic patterns, gene
        expression, and genomic mutation profiles. Our deliberation will uncover latent strategies
        for personalized therapeutic of both EOCRC and LOCRC.
  observational model: Cohort
  time perspective: Retrospective
  measure: OS
  time frame: 5 years after intervention
  description: overall survival
  arm group label: EOCRC
  description: Patients aged<50 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.
  arm group label: IOCRC
  description: Patients aged between 50 to 70 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.
  arm group label: LOCRC
  description: Patients aged between≥70 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.
  intervention type: Other
  intervention name: standardized treatment
  description: Patients enrolled in these 2 cohorts all received standardized treatment of colorectal cancer.
  arm group label: EOCRC
  arm group label: IOCRC
  arm group label: LOCRC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 95 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: LI XIN-XIANG
  investigator title: Professor
  mesh term: Colorectal Neoplasms