<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/NCT04496765</url>
  </required_header>
  <id_info>
    <org_study_id>Mansoura2020</org_study_id>
    <nct_id>NCT04496765</nct_id>
  </id_info>
  <brief_title>Early-onset Rectal Cancer</brief_title>
  <official_title>Patients With Early-Onset Rectal Cancer Aged 40 Year or Less Have Similar Oncologic Outcomes to Older Patients Despite Presenting in More Advanced Stage; A Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      The present study aimed to review the characteristics and outcome of early-onset rectal&#xD;
      cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies&#xD;
      assessed this point of research in CRC overall, the investigators opted to focus upon rectal&#xD;
      cancer alone since it may represent a separate category, distinct from colon cancer, in this&#xD;
      age group with regards to presentation, tumor behavior, and outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2008</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</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>Local recurrence</measure>
    <time_frame>36 months after surgery</time_frame>
    <description>recurrence of rectal cancer within the anatomic vicinity of the pelvis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">244</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>&lt; 40 years</arm_group_label>
    <description>Patients with rectal cancer ageing 40 years or less</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&gt; 40 years</arm_group_label>
    <description>Patients with rectal cancer ageing more than 40 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total mesorectal excision</intervention_name>
    <description>Radical resection of rectal cancer and draining lymph nodes</description>
    <arm_group_label>&lt; 40 years</arm_group_label>
    <arm_group_label>&gt; 40 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of either gender aged 40 years or less who presented with rectal cancer of any&#xD;
        stage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of either gender aged 40 years or less who presented with rectal cancer of&#xD;
             any stage were included to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with colon cancer or other gastrointestinal cancer and patients who were lost&#xD;
             to follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh H Emile</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university hospital</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Sameh Emile</investigator_full_name>
    <investigator_title>Associate professor of surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04496765
org study id: Mansoura2020
nct id: NCT04496765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study aimed to review the characteristics and outcome of early-onset rectal
      cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies
      assessed this point of research in CRC overall, the investigators opted to focus upon rectal
      cancer alone since it may represent a separate category, distinct from colon cancer, in this
      age group with regards to presentation, tumor behavior, and outcome.
observational model: Cohort
time perspective: Retrospective
measure: Local recurrence
time frame: 36 months after surgery
description: recurrence of rectal cancer within the anatomic vicinity of the pelvis
arm group label: < 40 years
description: Patients with rectal cancer ageing 40 years or less
arm group label: > 40 years
description: Patients with rectal cancer ageing more than 40 years
intervention type: Procedure
intervention name: Total mesorectal excision
description: Radical resection of rectal cancer and draining lymph nodes
arm group label: < 40 years
arm group label: > 40 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sameh H Emile
role: Study Chair
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Emile
investigator title: Associate professor of surgery
mesh term: Rectal Neoplasms
sharing ipd: Undecided