<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/NCT02193464</url>
  </required_header>
  <id_info>
    <org_study_id>EPICODE</org_study_id>
    <nct_id>NCT02193464</nct_id>
  </id_info>
  <brief_title>Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk</brief_title>
  <acronym>EPICODE</acronym>
  <official_title>Observational Study Using Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk, Southeastern Area of Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yeungnam University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Catholic University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the incidence and natural course of inflammatory&#xD;
      bowel disease in the southeastern area of Korea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>All newly diagnosed cases</measure>
    <time_frame>one year</time_frame>
    <description>In one year, all inflammatory bowel disease including Crohn's disease and ulcerative colitis which is newly diagnosed in Daegu-Gyeongbuk province of Korea is recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All operation cases</measure>
    <time_frame>one year</time_frame>
    <description>For one year, all patients who have surgical managements for IBD are counted.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>All cases of disease relapse</measure>
    <time_frame>one year</time_frame>
    <description>For one year, all patients who have disease worsening are counted.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Idiopathic Chronic Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>inflammatory bowel disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with inflammatory bowel disease from primary, secondary, and tertiary hospital&#xD;
        in Daegu-Gyeongbuk province of Korea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of inflammatory bowel disease including Crohn's disease and&#xD;
             ulcerative colitis&#xD;
&#xD;
          -  Followed up for at least 6 months for the correct diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not live in Daegu-Gyeongbuk province&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eun Soo Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eun Soo Kim, MD. PhD</last_name>
    <phone>+82-53-250-7088</phone>
    <email>dandy813@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eun Soo Kim, MD, PhD</last_name>
      <email>dandy813@hanmail.net</email>
    </contact>
    <investigator>
      <last_name>Eun Soo Kim, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Eun Soo Kim, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>inflammatory bowel disease, registry, incidence, Korea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT02193464
org study id: EPICODE
nct id: NCT02193464
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the incidence and natural course of inflammatory
      bowel disease in the southeastern area of Korea.
observational model: Cohort
time perspective: Prospective
measure: All newly diagnosed cases
time frame: one year
description: In one year, all inflammatory bowel disease including Crohn's disease and ulcerative colitis which is newly diagnosed in Daegu-Gyeongbuk province of Korea is recorded.
measure: All operation cases
time frame: one year
description: For one year, all patients who have surgical managements for IBD are counted.
measure: All cases of disease relapse
time frame: one year
description: For one year, all patients who have disease worsening are counted.
arm group label: inflammatory bowel disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eun Soo Kim, MD, PhD
role: Principal Investigator
affiliation: Keimyung University School of Medicine
last name: Eun Soo Kim, MD. PhD
phone: +82-53-250-7088
email: dandy813@hanmail.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Eun Soo Kim, MD, PhD
investigator title: Professor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases