<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/NCT01719198</url>
  </required_header>
  <id_info>
    <org_study_id>KUH1220</org_study_id>
    <nct_id>NCT01719198</nct_id>
  </id_info>
  <brief_title>Usefulness of Calprotectin for Colon Adenoma Screening</brief_title>
  <official_title>Usefulness of Fecal Calprotectin for Screening Colon Adenoma in Korean Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the&#xD;
      assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin&#xD;
      level, which could mean the role of fecal calprotectin as a screening marker for colon&#xD;
      adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for&#xD;
      screening in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">March 2013</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>fecal calprotectin level</measure>
    <time_frame>1 day (at the hospital visit)</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colon Adenoma</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      stool specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients who visit KUH healthcare center for colonoscopy in Korea over 18 years old adult&#xD;
        population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years old adult population&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yeo-Min Yun, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Konkuk University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>147-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chul Min Park, MD</last_name>
      <email>i004@snu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Chul Min Park, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
    <investigator_full_name>Chul Min Park, MD</investigator_full_name>
    <investigator_title>clinical instructor</investigator_title>
  </responsible_party>
  <keyword>adenoma</keyword>
  <keyword>calprotectin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT01719198
org study id: KUH1220
nct id: NCT01719198
lead sponsor: 
has dmc: No
The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the
      assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin
      level, which could mean the role of fecal calprotectin as a screening marker for colon
      adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for
      screening in this study.
observational model: Cohort
time perspective: Prospective
measure: fecal calprotectin level
time frame: 1 day (at the hospital visit)
stool specimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yeo-Min Yun, MD, PhD
role: Principal Investigator
affiliation: Konkuk University
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Konkuk University Medical Center
investigator full name: Chul Min Park, MD
investigator title: clinical instructor
mesh term: Adenoma