{
  "FullStudy":{
    "Rank":218089,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512875",
          "OrgStudyIdInfo":{
            "OrgStudyId":"S1119"
          },
          "Organization":{
            "OrgFullName":"Southwest Oncology Group",
            "OrgClass":"NETWORK"
          },
          "BriefTitle":"S1119 Peruvian H. Pylori Water Contamination Study",
          "OfficialTitle":"Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 16, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 17, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Southwest Oncology Group",
            "LeadSponsorClass":"NETWORK"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University of Michigan",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Hope Foundation",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The objective of this study is to elucidate the role of drinking water derived from the public source in Lima, Peru and transmission of H. pylori infection using genotypic techniques.",
          "DetailedDescription":"The objective of this study is to detect the presence of Helicobacter Pylori in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima (Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Martin de Porres, Villa El Salvador, and Villa Maria del Triunfo) with high and low incidence of gastric carcinoma. The secondary objective of this study is to establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Helicobacter Pylori Infection"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Helicobacter pylori",
              "water contamination",
              "Lima, Peru"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"tissue"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"107",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"biopsy proven H. pylori",
                "ArmGroupDescription":"Patient must have lived in the districts of Lima, Peru listed in the protocol."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Detect H. pylori in public drinking water of Lima Peru",
                "PrimaryOutcomeDescription":"To detect the presence of Helicobacter Pylori (H. pylori) in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima, Peru (districts detailed in protocol).",
                "PrimaryOutcomeTimeFrame":"within 1 year of receving last sample"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Correlation of H. pylori in water and those of stomachs of patients with symptoms",
                "SecondaryOutcomeDescription":"To establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.",
                "SecondaryOutcomeTimeFrame":"Within 1 year of receiving last sample"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nadults between the ages of 21-70 years old who have lived for more than 10 years in the Lima districts listed in protocol,\nwho have a biopsy proven diagnosis of infection by H. pylori.\nparticipants must be in good general condition, mentally competent and able to provide informed consent;\nmust not show evidence of dehydration or jaundice;\nmust be willing to complete the patient questionnaires.\nparticipants must not have known allergies to any of the antibiotics used in the study.\n\nExclusion Criteria:\n\npregnancy",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"21 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Residents of the following districts of Lima, Peru: Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Luis, San Martin de Porres, Via El Salvador, Villa Maria del Triunfo.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Manuel Valdivieso, M.D.",
                "OverallOfficialAffiliation":"Southwest Oncology Group",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Universidad Peruana Cayetano Heredia",
                "LocationCity":"Lima",
                "LocationCountry":"Peru"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"SWOG website: protocol abstract for S1119",
                "SeeAlsoLinkURL":"http://www.swog.org/Visitors/ViewProtocolDetails.asp?ProtocolID=2223"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007239",
                "ConditionMeshTerm":"Infection"
              },{
                "ConditionMeshId":"D000016481",
                "ConditionMeshTerm":"Helicobacter Infections"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000016905",
                "ConditionAncestorTerm":"Gram-Negative Bacterial Infections"
              },{
                "ConditionAncestorId":"D000001424",
                "ConditionAncestorTerm":"Bacterial Infections"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafAsFound":"Infection",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14647",
                "ConditionBrowseLeafName":"Stomach Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M17469",
                "ConditionBrowseLeafName":"Helicobacter Infections",
                "ConditionBrowseLeafAsFound":"Helicobacter Pylori Infection",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3303",
                "ConditionBrowseLeafName":"Bacterial Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M17832",
                "ConditionBrowseLeafName":"Gram-Negative Bacterial Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T5511",
                "ConditionBrowseLeafName":"Stomach Cancer",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}