<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/NCT01731665</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0634</org_study_id>
    <nct_id>NCT01731665</nct_id>
  </id_info>
  <brief_title>Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.</brief_title>
  <official_title>Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Police Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul Veterans Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>hansol hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kangdong Seoul Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jamsil Seoul Surgical Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Song Do Colorectal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daehang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kangdong Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics&#xD;
      and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul,&#xD;
      Korea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inflammatory bowel disease (IBD), which is comprised of Crohn's disease (CD) and ulcerative&#xD;
      colitis (UC) is a chronic inflammatory disease of gut with uncertain etiopathogenesis.&#xD;
      According to our previous study (Yang, et al. Inflamm Bowel Dis 2008; 14: 542-549), the&#xD;
      incidence and prevalence of IBD in Korea are still low compared with those in Western&#xD;
      countries, but are rapidly increasing. However, the long-term trends of epidemiology of CD&#xD;
      and UC together with their characteristics and prognosis in Korea are uncertain yet. The&#xD;
      investigators therefore aim to elucidate the incidence and prevalence of CD and UC over a&#xD;
      30-year period, from 1986 to 2017, in the Songpa-Kangdong district of Seoul, Korea. In&#xD;
      addition, the investigators also aim to reveal the clinical features at the time of diagnosis&#xD;
      of IBD, long-term evolution of disease and prognosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Anticipated">June 2029</completion_date>
  <primary_completion_date type="Anticipated">June 2029</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate and prevalence rate of IBD</measure>
    <time_frame>1986-2017 (up to 31 years)</time_frame>
    <description>Annual incidence rate of Crohn's disease and ulcerative colitis&#xD;
Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical features of patients with IBD</measure>
    <time_frame>1986-2017 (up to 31 years)</time_frame>
    <description>Clinical characteristics of patients newly diagnosed with Crohn's disease or ulcerative colitis: gender, presenting symptoms, duration between symptoms to diagnosis, and phenotypes, etc.&#xD;
Clinical course of patients newly diagnosed with Crohn's disease or ulcerative colitis: development of complications (strictures, perforations), intestinal resection rate, hospitalization rate, mortality, and pregnancies and their outcomes&#xD;
Treatment modalities of IBD and their trends: use of medication (5-ASA, corticosteroids, immunomodulators, and biologic agents, etc.)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Epidemiology</condition>
  <condition>Korea</condition>
  <arm_group>
    <arm_group_label>The Songpa-Kangdong cohort of IBD</arm_group_label>
    <description>Incident cases of IBD in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. For the prevalent cases, the inhabitants with IBD at Dec 31, 2007 in the Songpa-Kangdong district are included.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study is performed in the Songpa-Kangdong district, a well-defined administrative area&#xD;
        in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was&#xD;
        diagnosed, until 2017. The population of the study area was racially and ethnically&#xD;
        homogeneous and was relatively stable in number.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Definite cases of CD and UC&#xD;
&#xD;
        Patients are diagnosed with CD if they meet at least 2 of the following criteria:&#xD;
&#xD;
          1. clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal&#xD;
             bleeding&#xD;
&#xD;
          2. endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or&#xD;
             perianal disease&#xD;
&#xD;
          3. radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration&#xD;
&#xD;
          4. macroscopic appearance of bowel wall induration, mesenteric lymphadenopathy, and&#xD;
             &quot;creeping fat&quot; at laparotomy&#xD;
&#xD;
          5. pathologic findings of transmural inflammation and/or epithelioid granulomas&#xD;
&#xD;
        Only patients who meet these criteria for at least 2 months are included.&#xD;
&#xD;
        Patients are diagnosed with UC only if all 3 of the following criteria are present&#xD;
&#xD;
          1. a typical history of diarrhea or blood and pus or both in the stool for longer than 4&#xD;
             weeks&#xD;
&#xD;
          2. a typical sigmoidoscopic or colonoscopic picture with diffusely granular, friable, or&#xD;
             ulcerated mucosa without rectal sparing or skip lesions or radiological signs of&#xD;
             characteristic continuous granular or ulcerated mucosa&#xD;
&#xD;
          3. characteristic histopathological signs of inflammation on biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IBD unclassified&#xD;
&#xD;
          -  Ethnic groups other than Korean&#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>Suk-Kyun Yang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suk-Kyun Yang, M.D.</last_name>
    <phone>+82-2-3010-3901</phone>
    <email>sky@amc.seoul.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Byong Duk Ye, M.D.</last_name>
    <phone>+82-2-3010-3181</phone>
    <email>bdye@amc.seoul.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suk-Kyun Yang, M.D.</last_name>
      <phone>+82-2-3010-3901</phone>
      <email>sky@amc.seoul.kr</email>
    </contact>
    <contact_backup>
      <last_name>Byong Duk Ye, M.D.</last_name>
      <phone>+82-2-3010-3181</phone>
      <email>bdye@amc.seoul.kr</email>
    </contact_backup>
    <investigator>
      <last_name>Suk-Kyun Yang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Yang SK, Yun S, Kim JH, Park JY, Kim HY, Kim YH, Chang DK, Kim JS, Song IS, Park JB, Park ER, Kim KJ, Moon G, Yang SH. Epidemiology of inflammatory bowel disease in the Songpa-Kangdong district, Seoul, Korea, 1986-2005: a KASID study. Inflamm Bowel Dis. 2008 Apr;14(4):542-9. doi: 10.1002/ibd.20310.</citation>
    <PMID>17941073</PMID>
  </reference>
  <reference>
    <citation>Yang SK, Hong WS, Min YI, Kim HY, Yoo JY, Rhee PL, Rhee JC, Chang DK, Song IS, Jung SA, Park EB, Yoo HM, Lee DK, Kim YK. Incidence and prevalence of ulcerative colitis in the Songpa-Kangdong District, Seoul, Korea, 1986-1997. J Gastroenterol Hepatol. 2000 Sep;15(9):1037-42. doi: 10.1046/j.1440-1746.2000.02252.x.</citation>
    <PMID>11059934</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Suk-Kyun Yang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>ulcerative colitis</keyword>
  <keyword>epidemiology</keyword>
  <keyword>Korea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT01731665
org study id: 2012-0634
nct id: NCT01731665
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics
      and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul,
      Korea.
Inflammatory bowel disease (IBD), which is comprised of Crohn's disease (CD) and ulcerative
      colitis (UC) is a chronic inflammatory disease of gut with uncertain etiopathogenesis.
      According to our previous study (Yang, et al. Inflamm Bowel Dis 2008; 14: 542-549), the
      incidence and prevalence of IBD in Korea are still low compared with those in Western
      countries, but are rapidly increasing. However, the long-term trends of epidemiology of CD
      and UC together with their characteristics and prognosis in Korea are uncertain yet. The
      investigators therefore aim to elucidate the incidence and prevalence of CD and UC over a
      30-year period, from 1986 to 2017, in the Songpa-Kangdong district of Seoul, Korea. In
      addition, the investigators also aim to reveal the clinical features at the time of diagnosis
      of IBD, long-term evolution of disease and prognosis.
observational model: Cohort
time perspective: Other
measure: Incidence rate and prevalence rate of IBD
time frame: 1986-2017 (up to 31 years)
description: Annual incidence rate of Crohn's disease and ulcerative colitis
Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.
measure: Clinical features of patients with IBD
time frame: 1986-2017 (up to 31 years)
description: Clinical characteristics of patients newly diagnosed with Crohn's disease or ulcerative colitis: gender, presenting symptoms, duration between symptoms to diagnosis, and phenotypes, etc.
Clinical course of patients newly diagnosed with Crohn's disease or ulcerative colitis: development of complications (strictures, perforations), intestinal resection rate, hospitalization rate, mortality, and pregnancies and their outcomes
Treatment modalities of IBD and their trends: use of medication (5-ASA, corticosteroids, immunomodulators, and biologic agents, etc.)
arm group label: The Songpa-Kangdong cohort of IBD
description: Incident cases of IBD in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. For the prevalent cases, the inhabitants with IBD at Dec 31, 2007 in the Songpa-Kangdong district are included.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Suk-Kyun Yang, M.D.
role: Principal Investigator
affiliation: Asan Medical Center
last name: Suk-Kyun Yang, M.D.
phone: +82-2-3010-3901
email: sky@amc.seoul.kr
last name: Byong Duk Ye, M.D.
phone: +82-2-3010-3181
email: bdye@amc.seoul.kr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Korea, Republic of
citation: Yang SK, Yun S, Kim JH, Park JY, Kim HY, Kim YH, Chang DK, Kim JS, Song IS, Park JB, Park ER, Kim KJ, Moon G, Yang SH. Epidemiology of inflammatory bowel disease in the Songpa-Kangdong district, Seoul, Korea, 1986-2005: a KASID study. Inflamm Bowel Dis. 2008 Apr;14(4):542-9. doi: 10.1002/ibd.20310.
PMID: 17941073
citation: Yang SK, Hong WS, Min YI, Kim HY, Yoo JY, Rhee PL, Rhee JC, Chang DK, Song IS, Jung SA, Park EB, Yoo HM, Lee DK, Kim YK. Incidence and prevalence of ulcerative colitis in the Songpa-Kangdong District, Seoul, Korea, 1986-1997. J Gastroenterol Hepatol. 2000 Sep;15(9):1037-42. doi: 10.1046/j.1440-1746.2000.02252.x.
PMID: 11059934
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Suk-Kyun Yang
investigator title: Professor
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Inflammatory Bowel Diseases
sharing ipd: No