Nctid:
NCT00001254
Payload:
{"FullStudy"=>{"Rank"=>498097, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000015043", "ConditionMeshTerm"=>"Zollinger-Ellison Syndrome"}, {"ConditionMeshId"=>"D000015408", "ConditionMeshTerm"=>"Gastrinoma"}, {"ConditionMeshId"=>"D000013577", "ConditionMeshTerm"=>"Syndrome"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000004194", "ConditionAncestorTerm"=>"Disease"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000009384", "ConditionAncestorTerm"=>"Paraneoplastic Endocrine Syndromes"}, {"ConditionAncestorId"=>"D000010257", "ConditionAncestorTerm"=>"Paraneoplastic Syndromes"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000005770", "ConditionAncestorTerm"=>"Gastrointestinal Neoplasms"}, {"ConditionAncestorId"=>"D000004067", "ConditionAncestorTerm"=>"Digestive System Neoplasms"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System Diseases"}, {"ConditionAncestorId"=>"D000005767", "ConditionAncestorTerm"=>"Gastrointestinal Diseases"}, {"ConditionAncestorId"=>"D000010437", "ConditionAncestorTerm"=>"Peptic Ulcer"}, {"ConditionAncestorId"=>"D000004378", "ConditionAncestorTerm"=>"Duodenal Diseases"}, {"ConditionAncestorId"=>"D000007410", "ConditionAncestorTerm"=>"Intestinal Diseases"}, {"ConditionAncestorId"=>"D000013272", "ConditionAncestorTerm"=>"Stomach Diseases"}, {"ConditionAncestorId"=>"D000018273", "ConditionAncestorTerm"=>"Carcinoma, Islet Cell"}, {"ConditionAncestorId"=>"D000000230", "ConditionAncestorTerm"=>"Adenocarcinoma"}, {"ConditionAncestorId"=>"D000002277", "ConditionAncestorTerm"=>"Carcinoma"}, {"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000010190", "ConditionAncestorTerm"=>"Pancreatic Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000004701", "ConditionAncestorTerm"=>"Endocrine Gland Neoplasms"}, {"ConditionAncestorId"=>"D000010182", "ConditionAncestorTerm"=>"Pancreatic Diseases"}, {"ConditionAncestorId"=>"D000004700", "ConditionAncestorTerm"=>"Endocrine System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafAsFound"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13110", "ConditionBrowseLeafName"=>"Pancreatic Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18083", "ConditionBrowseLeafName"=>"Gastrinoma", "ConditionBrowseLeafAsFound"=>"Zollinger-Ellison Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17778", "ConditionBrowseLeafName"=>"Zollinger-Ellison Syndrome", "ConditionBrowseLeafAsFound"=>"Zollinger-Ellison Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13170", "ConditionBrowseLeafName"=>"Paraneoplastic Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8886", "ConditionBrowseLeafName"=>"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7256", "ConditionBrowseLeafName"=>"Digestive System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7255", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8883", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17206", "ConditionBrowseLeafName"=>"Ulcer", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13348", "ConditionBrowseLeafName"=>"Peptic Ulcer", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7552", "ConditionBrowseLeafName"=>"Duodenal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10444", "ConditionBrowseLeafName"=>"Intestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16062", "ConditionBrowseLeafName"=>"Stomach Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5534", "ConditionBrowseLeafName"=>"Carcinoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20418", "ConditionBrowseLeafName"=>"Carcinoma, Islet Cell", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3585", "ConditionBrowseLeafName"=>"Adenocarcinoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12320", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7863", "ConditionBrowseLeafName"=>"Endocrine Gland Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13102", "ConditionBrowseLeafName"=>"Pancreatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7862", "ConditionBrowseLeafName"=>"Endocrine System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T4387", "ConditionBrowseLeafName"=>"Pancreatic Cancer", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T6029", "ConditionBrowseLeafName"=>"Zollinger-Ellison Syndrome", "ConditionBrowseLeafAsFound"=>"Zollinger-Ellison Syndrome", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"Gland and Hormone Related Diseases", "ConditionBrowseBranchAbbrev"=>"BC19"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"273"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"October 29, 1991", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 5, 2023", "LastUpdateSubmitDate"=>"June 19, 2024", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 21, 2024", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"To determine an approach to the localization and management of tumor in patients with ZES.", "PrimaryOutcomeTimeFrame"=>"Yearly", "PrimaryOutcomeDescription"=>"localization of tumor"}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Zollinger-Ellison Syndrome", "Natural History"]}, "ConditionList"=>{"Condition"=>["Zollinger Ellison Syndrome"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3309661", "ReferenceType"=>"background", "ReferenceCitation"=>"Wolfe MM, Jensen RT. Zollinger-Ellison syndrome. Current concepts in diagnosis and management. N Engl J Med. 1987 Nov 5;317(19):1200-9. doi: 10.1056/NEJM198711053171907."}, {"ReferencePMID"=>"2686566", "ReferenceType"=>"background", "ReferenceCitation"=>"Andersen DK. Current diagnosis and management of Zollinger-Ellison syndrome. Ann Surg. 1989 Dec;210(6):685-703. doi: 10.1097/00000658-198912000-00001."}, {"ReferencePMID"=>"45919", "ReferenceType"=>"background", "ReferenceCitation"=>"Creutzfeldt W, Arnold R, Creutzfeldt C, Track NS. Pathomorphologic, biochemical, and diagnostic aspects of gastrinomas (Zollinger-Ellison syndrome). Hum Pathol. 1975 Jan;6(1):47-76. doi: 10.1016/s0046-8177(75)80109-2."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1990-DK-0137.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"This protocol concerns the approach to the localization, diagnosis of MEN1 and management of the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the subsequent management of the tumor and tissue samples for research.", "DetailedDescription"=>"This protocol concerns the approach to the localization and management of the tumor in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor and the subsequent management of the tumor."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"100 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "SamplingMethod"=>"Non-Probability Sample", "StudyPopulation"=>"patient population enrolled in protocol 89-DK-0015", "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nNew patients will be evaluated initially as described in the protocol entitled, \"Diagnostic evaluation of patients with suspected abnormalities of gastric secretion\" (89-DK-0005).\n\nOnly those patients that are being treated under the protocol entitled, \"Medical Therapy of Zollinger-Ellison Syndrome\" (protocol # 89-DK-0015) will be entered into this tumor localization and management protocol."}, "IdentificationModule"=>{"NCTId"=>"NCT00001254", "BriefTitle"=>"Evaluating Pancreatic Tumors in Patients With Zollinger-Ellison Syndrome", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Evaluation of the Gastrinoma in Patients With Zollinger-Ellison Syndrome", "OrgStudyIdInfo"=>{"OrgStudyId"=>"900137"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"90-DK-0137"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"Patients", "ArmGroupDescription"=>"Patients will Zollinger-Ellison Syndrome"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Robert T Jensen, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}