<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/NCT02184910</url>
  </required_header>
  <id_info>
    <org_study_id>4-2013-0722</org_study_id>
    <nct_id>NCT02184910</nct_id>
  </id_info>
  <brief_title>Usefulness of Serum Pepsinogen and Gastrin as the Predictive Biomarker of Atrophic Gastritis, Intestinal Metaplasia and Gastric Cancer in Korea</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which&#xD;
      leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to&#xD;
      assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for&#xD;
      atrophic gastritis and whether gastric atrophy based on the PG test would be improved after&#xD;
      H. pylori eradication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>4 Years</target_duration>
  <primary_outcome>
    <measure>the change of pepsinogen level before and after H. pylori eradication</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>to compare the change of the pepsinogen level before and after H. pylori eradication and evaluate the correlation between the pepsinogen level and the atrophic gastritis</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Atrophic Gastritis</condition>
  <arm_group>
    <arm_group_label>gastritis and pepsinogen</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pepsinogen and gastrin</intervention_name>
    <arm_group_label>gastritis and pepsinogen</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Over 19 years, the patients who have gastrointestinal discomfort or get&#xD;
        esophagastroduodenoscopy (EGD) for health check up, the patients who got the procedure,&#xD;
        endoscopic submucosal resection (ESD) for early gastric cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. over 19 years&#xD;
&#xD;
          2. the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy&#xD;
             (EGD) for health check up&#xD;
&#xD;
          3. the patients who got the procedure, endoscopic submucosal resection (ESD) for early&#xD;
             gastric cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. gastrectomy history&#xD;
&#xD;
          2. advanced gastric cancer (impossible to get the gastrectomy)&#xD;
&#xD;
          3. Helicobacter eradication history&#xD;
&#xD;
          4. the patients who have chronic disease&#xD;
&#xD;
          5. cancer patients except gastric cancer within 6 months&#xD;
&#xD;
          6. who cannot perform this study according to research's decision&#xD;
&#xD;
          7. who have bleeding tendency (ex. taking antiplatelet agent, low platelet count or&#xD;
             abnormal coagulation time)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yong Chan Lee, MD, PhD</last_name>
    <phone>82-2-2228-1960</phone>
    <email>leeyc@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Chan Lee, MD, PhD</last_name>
      <phone>82-2-2228-1960</phone>
      <email>leeyc@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrophic gastritis, pepsinogen, Helicobacter pylori</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastritis</mesh_term>
    <mesh_term>Gastritis, Atrophic</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrins</mesh_term>
  </intervention_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/NCT02184910
org study id: 4-2013-0722
nct id: NCT02184910
lead sponsor: 
has dmc: No
It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which
      leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to
      assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for
      atrophic gastritis and whether gastric atrophy based on the PG test would be improved after
      H. pylori eradication.
observational model: Cohort
time perspective: Prospective
measure: the change of pepsinogen level before and after H. pylori eradication
time frame: baseline and 6 months
description: to compare the change of the pepsinogen level before and after H. pylori eradication and evaluate the correlation between the pepsinogen level and the atrophic gastritis
arm group label: gastritis and pepsinogen
intervention type: Drug
intervention name: pepsinogen and gastrin
arm group label: gastritis and pepsinogen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Yong Chan Lee, MD, PhD
phone: 82-2-2228-1960
email: leeyc@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastritis
mesh term: Gastritis, Atrophic
mesh term: Atrophy
mesh term: Gastrins