<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/NCT02200250</url>
  </required_header>
  <id_info>
    <org_study_id>HREC2013/10/6.2(3838)QA</org_study_id>
    <nct_id>NCT02200250</nct_id>
  </id_info>
  <brief_title>Long Term Barrett's Endoscopic Mucosal Resection Study</brief_title>
  <acronym>CBE</acronym>
  <official_title>Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professor Michael Bourke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Sydney Local Health District</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for&#xD;
      Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study abandoned&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 1, 2021</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>Reviewing patients symptoms following resection</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Barretts Esophagus</condition>
  <arm_group>
    <arm_group_label>Post Barretts Excision</arm_group_label>
    <description>Patients who have undergone an EMR for Barretts Oesophagus</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have or have had Barrett's Oesophagus with high grade dysplasia or&#xD;
        adenocarcinoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or over&#xD;
&#xD;
          -  Have or have had Barrett's Oesophagus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not have Barrett's Oesophagus&#xD;
&#xD;
          -  Have not had Barrett's Oesophagus resected at Westmead Hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Bourke, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Sydney Local Health District</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westmead Endoscopy Unit</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Western Sydney Local Health District</investigator_affiliation>
    <investigator_full_name>Professor Michael Bourke</investigator_full_name>
    <investigator_title>Director of Gastrointestinal Endoscopy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200250
org study id: HREC2013/10/6.2(3838)QA
nct id: NCT02200250
lead sponsor: 
has dmc: Yes
Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for
      Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).
observational model: Cohort
time perspective: Retrospective
measure: Reviewing patients symptoms following resection
time frame: up to 3 years
description: Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back.
arm group label: Post Barretts Excision
description: Patients who have undergone an EMR for Barretts Oesophagus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Michael J Bourke, MBBS
role: Principal Investigator
affiliation: Western Sydney Local Health District
facility: 
country: Australia
responsible party type: Sponsor-Investigator
investigator affiliation: Western Sydney Local Health District
investigator full name: Professor Michael Bourke
investigator title: Director of Gastrointestinal Endoscopy
mesh term: Barrett Esophagus