Nctid:
NCT00001254
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015043", "term"=>"Zollinger-Ellison Syndrome"}, {"id"=>"D015408", "term"=>"Gastrinoma"}, {"id"=>"D013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D009384", "term"=>"Paraneoplastic Endocrine Syndromes"}, {"id"=>"D010257", "term"=>"Paraneoplastic Syndromes"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D010437", "term"=>"Peptic Ulcer"}, {"id"=>"D004378", "term"=>"Duodenal Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}, {"id"=>"D013272", "term"=>"Stomach Diseases"}, {"id"=>"D018273", "term"=>"Carcinoma, Islet Cell"}, {"id"=>"D000230", "term"=>"Adenocarcinoma"}, {"id"=>"D002277", "term"=>"Carcinoma"}, {"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D010190", "term"=>"Pancreatic Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13110", "name"=>"Pancreatic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M18083", "name"=>"Gastrinoma", "asFound"=>"Zollinger-Ellison Syndrome", "relevance"=>"HIGH"}, {"id"=>"M17778", "name"=>"Zollinger-Ellison Syndrome", "asFound"=>"Zollinger-Ellison Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13170", "name"=>"Paraneoplastic Syndromes", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M17206", "name"=>"Ulcer", "relevance"=>"LOW"}, {"id"=>"M13348", "name"=>"Peptic Ulcer", "relevance"=>"LOW"}, {"id"=>"M7552", "name"=>"Duodenal Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M16062", "name"=>"Stomach Diseases", "relevance"=>"LOW"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M20418", "name"=>"Carcinoma, Islet Cell", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"T4387", "name"=>"Pancreatic Cancer", "relevance"=>"LOW"}, {"id"=>"T6029", "name"=>"Zollinger-Ellison Syndrome", "asFound"=>"Zollinger-Ellison Syndrome", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>273}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1991-10-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08-05", "lastUpdateSubmitDate"=>"2024-12-05", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-06", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To determine an approach to the localization and management of tumor in patients with ZES.", "timeFrame"=>"Yearly", "description"=>"localization of tumor"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Zollinger-Ellison Syndrome", "Natural History"], "conditions"=>["Zollinger Ellison Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3309661", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"2686566", "type"=>"BACKGROUND", "citation"=>"Andersen DK. Current diagnosis and management of Zollinger-Ellison syndrome. Ann Surg. 1989 Dec;210(6):685-703. doi: 10.1097/00000658-198912000-00001."}, {"pmid"=>"45919", "type"=>"BACKGROUND", "citation"=>"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."}], "seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1990-DK-0137.html", "label"=>"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"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"patient population enrolled in protocol 89-DK-0015", "healthyVolunteers"=>false, "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"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Evaluation of the Gastrinoma in Patients With Zollinger-Ellison Syndrome", "orgStudyIdInfo"=>{"id"=>"900137"}, "secondaryIdInfos"=>[{"id"=>"90-DK-0137"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients", "description"=>"Patients will Zollinger-Ellison Syndrome"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Robert T Jensen, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
