<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/NCT02198976</url>
  </required_header>
  <id_info>
    <org_study_id>HREC2013/10/4.1 (3829)</org_study_id>
    <nct_id>NCT02198976</nct_id>
  </id_info>
  <brief_title>Australian Barrett's Cohort With Dysplasia and Early Cancer Study</brief_title>
  <acronym>ABCDE</acronym>
  <official_title>Australian Barrett's Cohort With Dysplasia and Early Cancer Study</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>
      The purpose of this study is to collect prospective observational data regarding endoscopic&#xD;
      management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia&#xD;
      and/or intramucosal carcinoma. To observe the natural history of patients with low grade&#xD;
      dysplastic and non dysplastic Barrett's oesophagus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Serious and Non-Serious Adverse Events</measure>
    <time_frame>During the Barretts Excision</time_frame>
    <description>Collect prospective observational data on patients undergoing endoluminal therapy for dysplastic BO to determine&#xD;
Long term risk of oesophageal adenocarcinoma (OAC) development&#xD;
Long term efficacy (dysplasia and metaplasia free) in both long and short segment BO&#xD;
Short and long term safety and complications&#xD;
Comparison of the safety, long term efficacy, cost and patient tolerability between endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) Document the endoscopic location and characterise morphology of HGD/IMC in short and long segment BO Define the short term and long term causes of morbidity / mortality of patients undergoing ER This will be recorded on a datasheet, de-identified during the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>Up to 5 years after procedure</time_frame>
    <description>Establish the effect of endoluminal therapies for BO HGD/IMC on oesophageal motility. Document and grade the post EMR oesophageal defect and establish a possible link to subsequent complications (including stricture, bleeding and perforation) and recurrence. Perform cost-utility analyses comparing different treatment approaches for BO HGD/IMC, including EMR, RFA and oesophagectomy. Establish the relationship between Obstructive Sleep Apnea and BO. Understand patient attitudes and perceptions regarding BO, its treatment and its implication.&#xD;
Participants will be approached following their procedure and data recorded on a datasheet, this data will be linked to the initial procedure outcomes.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Barrett's Esophagus</condition>
  <arm_group>
    <arm_group_label>Barrett's Oesophagus</arm_group_label>
    <description>Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus&#xD;
        for removal.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Can give informed consent to trial participation&#xD;
&#xD;
          -  Age greater than 18&#xD;
&#xD;
          -  Barrett's oesophagus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18&#xD;
&#xD;
          -  Pregnant patients&#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>
  <overall_contact>
    <last_name>Kathleen Goodrick, BN</last_name>
    <phone>98455555</phone>
    <phone_ext>59779</phone_ext>
    <email>kathleen.goodrick@health.nsw.gov.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Farzan F Bahin, MBBS</last_name>
    <phone>98455555</phone>
    <phone_ext>56700</phone_ext>
    <email>farzan.fahrtash@sydney.edu.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Westmead Endoscopy Unit</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Goodrick, BN</last_name>
      <phone>98455555</phone>
      <phone_ext>59779</phone_ext>
      <email>kathleen.goodrick@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Michael Bourke, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Farzan Bahin, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </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 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 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">June 29, 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/NCT02198976
org study id: HREC2013/10/4.1 (3829)
nct id: NCT02198976
lead sponsor: 
has dmc: Yes
The purpose of this study is to collect prospective observational data regarding endoscopic
      management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia
      and/or intramucosal carcinoma. To observe the natural history of patients with low grade
      dysplastic and non dysplastic Barrett's oesophagus
observational model: Cohort
time perspective: Prospective
measure: Number of Serious and Non-Serious Adverse Events
time frame: During the Barretts Excision
description: Collect prospective observational data on patients undergoing endoluminal therapy for dysplastic BO to determine
Long term risk of oesophageal adenocarcinoma (OAC) development
Long term efficacy (dysplasia and metaplasia free) in both long and short segment BO
Short and long term safety and complications
Comparison of the safety, long term efficacy, cost and patient tolerability between endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) Document the endoscopic location and characterise morphology of HGD/IMC in short and long segment BO Define the short term and long term causes of morbidity / mortality of patients undergoing ER This will be recorded on a datasheet, de-identified during the procedure.
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: Up to 5 years after procedure
description: Establish the effect of endoluminal therapies for BO HGD/IMC on oesophageal motility. Document and grade the post EMR oesophageal defect and establish a possible link to subsequent complications (including stricture, bleeding and perforation) and recurrence. Perform cost-utility analyses comparing different treatment approaches for BO HGD/IMC, including EMR, RFA and oesophagectomy. Establish the relationship between Obstructive Sleep Apnea and BO. Understand patient attitudes and perceptions regarding BO, its treatment and its implication.
Participants will be approached following their procedure and data recorded on a datasheet, this data will be linked to the initial procedure outcomes.
arm group label: Barrett's Oesophagus
description: Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC)
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
last name: Kathleen Goodrick, BN
phone: 98455555
phone ext: 59779
email: kathleen.goodrick@health.nsw.gov.au
last name: Farzan F Bahin, MBBS
phone: 98455555
phone ext: 56700
email: farzan.fahrtash@sydney.edu.au
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
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