<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/NCT03035136</url>
  </required_header>
  <id_info>
    <org_study_id>SSA/17/NALHN/3</org_study_id>
    <nct_id>NCT03035136</nct_id>
  </id_info>
  <brief_title>Retrospective Study on Epidemiology of Colorectal Lesions</brief_title>
  <official_title>Retrospective Study on Epidemiology of Colorectal Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lyell McEwin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lyell McEwin Hospital</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>
      Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on&#xD;
      colorectal lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">February 15, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of screening patients with at least one adenomatous lesion found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SSA/P detection rate</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of screening patients with at least one SSA/P found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of screening patients with at least one polyp found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2658</enrollment>
  <condition>ColoRectal Cancer</condition>
  <condition>Colonic Polyp</condition>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients with colorectal lesions</arm_group_label>
    <description>Patients with a full colonoscopy that showed either a cancer or a polyp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without colorectal lesions</arm_group_label>
    <description>Patients with a full colonoscopy that showed no polyps.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colonoscopies performed in Lyell McEwin Hospital between 2010-2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sigmoidoscopies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lyell McEwin Hospital</investigator_affiliation>
    <investigator_full_name>Leonardo Zorron Cheng Tao Pu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>polyps</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT03035136
org study id: SSA/17/NALHN/3
nct id: NCT03035136
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.
Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on
      colorectal lesions.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Adenoma detection rate
time frame: Day 1
description: Percentage of screening patients with at least one adenomatous lesion found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
measure: SSA/P detection rate
time frame: Day 1
description: Percentage of screening patients with at least one SSA/P found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
measure: Polyp detection rate
time frame: Day 1
description: Percentage of screening patients with at least one polyp found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
arm group label: Patients with colorectal lesions
description: Patients with a full colonoscopy that showed either a cancer or a polyp.
arm group label: Patients without colorectal lesions
description: Patients with a full colonoscopy that showed no polyps.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Lyell McEwin Hospital
investigator full name: Leonardo Zorron Cheng Tao Pu
investigator title: Principal Investigator
mesh term: Colonic Neoplasms
mesh term: Colonic Polyps
sharing ipd: No