{
  "FullStudy":{
    "Rank":218253,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510730",
          "OrgStudyIdInfo":{
            "OrgStudyId":"20052011"
          },
          "Organization":{
            "OrgFullName":"Seoul National University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors",
          "OfficialTitle":"Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2005"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 13, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 14, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jeongmin Choi",
            "ResponsiblePartyInvestigatorTitle":"M.D., Seoul National University Hospital",
            "ResponsiblePartyInvestigatorAffiliation":"Seoul National University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Seoul National University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.",
          "DetailedDescription":"The association between Helicobacter pylori infection and development of gastric cancer has been established by epidemiologic studies. Conversely, eradication of H. pylori showed no significant reduction of the incidence of gastric cancer in a large-scale, double-blind, randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and atrophy). In contrast, randomized prospective study in Japan showed that H. pylori eradication after endoscopic resection of early gastric cancer significantly reduced metachronous gastric cancer. To solve this conflicting issue is critical because gastric cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China have highest cancer incidence, and its incidence might decrease by H. pylori eradication treatment.\n\nWith respect to therapeutic modality, endoscopic resection for early gastric cancer is currently the established treatment of choice in Korea and Japan because it has been proven to be both minimally invasive and effective in the curative treatment of early gastric cancer.\n\nEndoscopic resection has also been performed in the gastric dysplasia because dysplasia has to some extent malignant potential although firm evidence is lacking. In comparison with surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients treated with endoscopic resection have higher possibility for metachronous gastric cancer than those treated with surgical resection.\n\nSo far, it has not yet been clearly established whether H pylori eradication for gastric tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We performed randomized controlled, open-label trial on the effect of new cancer development after H pylori eradication for gastric tumors."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Gastric Tumor",
              "Helicobacter Pylori",
              "Endoscopic Resection",
              "Metachronous Neoplasms"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "gastric tumor",
              "Helicobacter pylori",
              "endoscopic resection",
              "metachronous neoplasms"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"855",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"control group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"no treatment for Helicobacter pylori infection"
              },{
                "ArmGroupLabel":"treatment group",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"treatment group receive eradication treatment for helicobacter pylori infection",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: eradication treatment of Helicobacter pylori infection"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"eradication treatment of Helicobacter pylori infection",
                "InterventionDescription":"Eradication group receive Omeprazole sodium 20mg, amoxicillin 1g, clarithromycin 500mg orally at the same time twice daily for 7 days.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "treatment group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor.",
                "PrimaryOutcomeDescription":"Primary outcome is the incidence of new cancer development after endoscopic resection of gastric tumors between eradication and control groups. Previous reports showed the incidence of new cancer between two groups differs at least 3years.",
                "PrimaryOutcomeTimeFrame":"we set the time frame as at least three years."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor.",
                "SecondaryOutcomeDescription":"Gastric high grade dysplasia has high malignant potential. Considering this, we set high grade dysplasia as secondary outcome measurement.",
                "SecondaryOutcomeTimeFrame":"3 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nH pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia, and early gastric cancer\nGastric tumor is completely removed through endoscopic resection.\n\nExclusion Criteria:\n\nPatients underwent gastrectomy before enrollment\npatients underwent endoscopic resection before enrollment\nPrevious history of eradication for H. pylori\nPregnancy\nAged <20 yr old or aged >75 yr old\nPatients underwent additional gastrectomy due to incomplete endoscopic resection",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Sang Gyun Kim, professor",
                "OverallOfficialAffiliation":"Department of Internal Medicine and Liver Research Institute",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital",
                "LocationCity":"Seoul",
                "LocationZip":"110-744",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29800546",
                "ReferenceType":"derived",
                "ReferenceCitation":"Choi JM, Kim SG, Choi J, Park JY, Oh S, Yang HJ, Lim JH, Im JP, Kim JS, Jung HC. Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention: a randomized controlled trial. Gastrointest Endosc. 2018 Sep;88(3):475-485.e2. doi: 10.1016/j.gie.2018.05.009. Epub 2018 May 22."
              },{
                "ReferencePMID":"24100112",
                "ReferenceType":"derived",
                "ReferenceCitation":"Choi J, Kim SG, Yoon H, Im JP, Kim JS, Kim WH, Jung HC. Eradication of Helicobacter pylori after endoscopic resection of gastric tumors does not reduce incidence of metachronous gastric carcinoma. Clin Gastroenterol Hepatol. 2014 May;12(5):793-800.e1. doi: 10.1016/j.cgh.2013.09.057. Epub 2013 Oct 5."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013274",
                "ConditionMeshTerm":"Stomach Neoplasms"
              },{
                "ConditionMeshId":"D000016609",
                "ConditionMeshTerm":"Neoplasms, Second Primary"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000005770",
                "ConditionAncestorTerm":"Gastrointestinal Neoplasms"
              },{
                "ConditionAncestorId":"D000004067",
                "ConditionAncestorTerm":"Digestive System Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000013272",
                "ConditionAncestorTerm":"Stomach Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M17572",
                "ConditionBrowseLeafName":"Neoplasms, Second Primary",
                "ConditionBrowseLeafAsFound":"Metachronous Neoplasm",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14647",
                "ConditionBrowseLeafName":"Stomach Neoplasms",
                "ConditionBrowseLeafAsFound":"Gastric Tumor",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7469",
                "ConditionBrowseLeafName":"Gastrointestinal Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5839",
                "ConditionBrowseLeafName":"Digestive System Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14645",
                "ConditionBrowseLeafName":"Stomach Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T5511",
                "ConditionBrowseLeafName":"Stomach Cancer",
                "ConditionBrowseLeafAsFound":"Gastric Tumor",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}