<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/NCT01678027</url>
  </required_header>
  <id_info>
    <org_study_id>NCCCTS04-103</org_study_id>
    <nct_id>NCT01678027</nct_id>
  </id_info>
  <brief_title>Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication</brief_title>
  <official_title>Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence&#xD;
      of gastric cancer in subjects with family history of gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helicobacter pylori infection is associated with gastric cancer in epidemiological studies.&#xD;
      However, it is still unknown whether H. pylori eradication is useful and required to prevent&#xD;
      gastric cancer.&#xD;
&#xD;
      Gastric cancer risk is increased in family members of gastric cancer patient. Though there is&#xD;
      no direct evidence that H. pylori infection is a risk factor for gastric cancer in family&#xD;
      members of gastric cancer, current European guideline recommends H. pylori eradication in&#xD;
      first-degree relatives of gastric cancer patients.&#xD;
&#xD;
      In this study, the investigators will evaluate whether H. pylori eradication can reduce&#xD;
      gastric cancer risk in the first-degree family members of gastric cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2004</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric cancer incidence</measure>
    <time_frame>6 years after last participant enrollment</time_frame>
    <description>The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status.&#xD;
Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastric dysplasia incidence</measure>
    <time_frame>6 year after last participant enrollment</time_frame>
    <description>Incidence of gastric dysplasia according to the H. pylori treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups</measure>
    <time_frame>6 year after last participant enrollment</time_frame>
    <description>Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric cancer incidence according to H. pylori status</measure>
    <time_frame>6 year after last participant enrollment</time_frame>
    <description>Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>6 year after last participant enrollment</time_frame>
    <description>All-cause mortality between H. pylori treatment group and placebo group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1838</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Helicobacter Pylori Infection</condition>
  <condition>Family Members</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for LAC triple therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LAC triple therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PPI (Lansoprazole), Clarithromycin, Amoxicilline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LAC triple therapy</intervention_name>
    <description>Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.</description>
    <arm_group_label>LAC triple therapy</arm_group_label>
    <other_name>PPI-Clarithromycin containing triple therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and&#xD;
             biopsy&#xD;
&#xD;
          -  Informed consent should be signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastric cancer history&#xD;
&#xD;
          -  Other malignancy within the past 5 years&#xD;
&#xD;
          -  Hereditary cancer family member (HNPCC, FAP)&#xD;
&#xD;
          -  Peptic ulcer history&#xD;
&#xD;
          -  Peptic ulcer, esophageal cancer, gastric cancer case found at EGD&#xD;
&#xD;
          -  H. pylori eradication treatment history&#xD;
&#xD;
          -  Previous serious side effect to antibiotics&#xD;
&#xD;
          -  Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal&#xD;
             failure, cardiovascular diseases&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Psychiatric disorder that would preclude compliance, alcoholics&#xD;
&#xD;
          -  Refuse informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Il Ju Choi, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center, Korea</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Il Ju Choi</investigator_full_name>
    <investigator_title>M.D., Ph.D</investigator_title>
  </responsible_party>
  <keyword>Stomach neoplasm</keyword>
  <keyword>Helicobacter pylori</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clarithromycin</mesh_term>
  </intervention_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/NCT01678027
org study id: NCCCTS04-103
nct id: NCT01678027
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence
      of gastric cancer in subjects with family history of gastric cancer.
Helicobacter pylori infection is associated with gastric cancer in epidemiological studies.
      However, it is still unknown whether H. pylori eradication is useful and required to prevent
      gastric cancer.

      Gastric cancer risk is increased in family members of gastric cancer patient. Though there is
      no direct evidence that H. pylori infection is a risk factor for gastric cancer in family
      members of gastric cancer, current European guideline recommends H. pylori eradication in
      first-degree relatives of gastric cancer patients.

      In this study, the investigators will evaluate whether H. pylori eradication can reduce
      gastric cancer risk in the first-degree family members of gastric cancer patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gastric cancer incidence
time frame: 6 years after last participant enrollment
description: The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status.
Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.
measure: Gastric dysplasia incidence
time frame: 6 year after last participant enrollment
description: Incidence of gastric dysplasia according to the H. pylori treatment
measure: Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups
time frame: 6 year after last participant enrollment
description: Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group
measure: Gastric cancer incidence according to H. pylori status
time frame: 6 year after last participant enrollment
description: Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group
measure: All-cause mortality
time frame: 6 year after last participant enrollment
description: All-cause mortality between H. pylori treatment group and placebo group
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for LAC triple therapy
arm group label: LAC triple therapy
arm group type: Active Comparator
description: PPI (Lansoprazole), Clarithromycin, Amoxicilline
intervention type: Drug
intervention name: Placebo
description: Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
arm group label: Placebo
intervention type: Drug
intervention name: LAC triple therapy
description: Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
arm group label: LAC triple therapy
other name: PPI-Clarithromycin containing triple therapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Il Ju Choi, M.D., Ph.D.
role: Principal Investigator
affiliation: National Cancer Center, Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Il Ju Choi
investigator title: M.D., Ph.D
mesh term: Stomach Neoplasms
mesh term: Clarithromycin
sharing ipd: No