{
  "FullStudy":{
    "Rank":218001,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514045",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB-20285"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"SU-01172012-8987",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Stanford University"
              },{
                "SecondaryId":"GI0005",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"OnCore"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Stanford University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Gastric Cancer Foundation: A Gastric Cancer Registry",
          "OfficialTitle":"The Gastric Cancer Foundation: A Gastric Cancer Registry"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2019",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2021",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 27, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Stanford University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The Gastric Cancer Registry will combine data acquired directly from patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene via an online questionnaire with genomic data obtained from saliva, blood and tissue samples. The purpose of this registry is to gain better understanding of the causes of gastric cancer, both environmental and genetic; whether certain genomic data can predict outcomes of treatment and survival.",
          "DetailedDescription":"Collect detailed clinical and epidemiological information on eligible patients via an online registry and a detailed patient questionnaire. Participants can opt in to contribute a blood or saliva sample and paraffin block samples from a previous gastric surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Gastric Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Quality of Life"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Ecologic or Community"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Blood samples with DNA Paraffin embedded tissue will be stored in the Stanford Tissue Bank for 100 years."
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"500",
            "EnrollmentType":"Anticipated"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Collect detailed clinical and epidemiological information on patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene",
                "PrimaryOutcomeTimeFrame":"1 day"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients are eligible if they have a histologically proven gastric tumor including gastroesophageal tumors; OR they have a family history of gastric cancer in a first or second degree relative; OR persons with a known germline mutation in their CDH1 (E-Cadherin) gene.\n18 years of age or older\nAdequate English proficiency to complete online consent and questionnaire. Spanish-language proficiency as an alternative to English-language proficiency.\n\nExclusion Criteria:\n\nUnder 18 years of age\nNo history of gastric cancer or gastric cancer in a family member or a known germline mutation in their CDH1 gene.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Participants will be identified for recruitment either by the individual's treating physician or through information about the registry on the Gastric Cancer Fund website. Potential participants will be directed to the URL for the gastric cancer registry and asked to complete a brief registration form which will include eligibility questions.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Alison Almeda",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"650-497-3619",
                "CentralContactEMail":"GCRegistry@stanford.edu"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"James M Ford, MD",
                "OverallOfficialAffiliation":"Stanford University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Stanford University, School of Medicine",
                "LocationStatus":"Recruiting",
                "LocationCity":"Stanford",
                "LocationState":"California",
                "LocationZip":"94305",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Alison Almeda",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"650-497-3619",
                      "LocationContactEMail":"GCRegistry@stanford.edu"
                    },{
                      "LocationContactName":"James M Ford, MD",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Hanlee P Ji, MD",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013274",
                "ConditionMeshTerm":"Stomach Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000005770",
                "ConditionAncestorTerm":"Gastrointestinal Neoplasms"
              },{
                "ConditionAncestorId":"D000004067",
                "ConditionAncestorTerm":"Digestive System Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000013272",
                "ConditionAncestorTerm":"Stomach Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14647",
                "ConditionBrowseLeafName":"Stomach Neoplasms",
                "ConditionBrowseLeafAsFound":"Gastric Cancer",
                "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":"T6054",
                "ConditionBrowseLeafName":"Quality of Life",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T5511",
                "ConditionBrowseLeafName":"Stomach Cancer",
                "ConditionBrowseLeafAsFound":"Gastric Cancer",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}

