Nctid:
NCT00001205
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D020019", "term"=>"Neurocysticercosis"}, {"id"=>"D003551", "term"=>"Cysticercosis"}, {"id"=>"D013622", "term"=>"Taeniasis"}], "ancestors"=>[{"id"=>"D020809", "term"=>"Central Nervous System Helminthiasis"}, {"id"=>"D020807", "term"=>"Central Nervous System Parasitic Infections"}, {"id"=>"D002494", "term"=>"Central Nervous System Infections"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D010272", "term"=>"Parasitic Diseases"}, {"id"=>"D002590", "term"=>"Cestode Infections"}, {"id"=>"D006373", "term"=>"Helminthiasis"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M15452", "name"=>"Seizures", "relevance"=>"LOW"}, {"id"=>"M9907", "name"=>"Hydrocephalus", "relevance"=>"LOW"}, {"id"=>"M11564", "name"=>"Meningitis", "relevance"=>"LOW"}, {"id"=>"M6756", "name"=>"Cysticercosis", "asFound"=>"Neurocysticercosis", "relevance"=>"HIGH"}, {"id"=>"M16396", "name"=>"Taeniasis", "asFound"=>"Neurocysticercosis", "relevance"=>"HIGH"}, {"id"=>"M21874", "name"=>"Neurocysticercosis", "asFound"=>"Neurocysticercosis", "relevance"=>"HIGH"}, {"id"=>"M11565", "name"=>"Meningitis, Aseptic", "relevance"=>"LOW"}, {"id"=>"M9461", "name"=>"Helminthiasis", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M13185", "name"=>"Parasitic Diseases", "relevance"=>"LOW"}, {"id"=>"M5743", "name"=>"Central Nervous System Infections", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"T1713", "name"=>"Cysticercosis", "asFound"=>"Neurocysticercosis", "relevance"=>"HIGH"}, {"id"=>"T2684", "name"=>"Helminthiasis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>500}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"1985-10-07", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11-21", "lastUpdateSubmitDate"=>"2024-12-18", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-19", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To characterise the radiographic, biochemical, and clinical course of neurocysticercosis during and after treatment with long-term follow-up, with the goal of documenting a disease free state off anthelmintics for 7 years", "timeFrame"=>"7 years-indefinite", "description"=>"To study the clinical course of cysticercosis following therapy and diminish morbidity associated with treatment of cysticercosis including neurocysticercosis or the inflammation associated with therapy"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Tapeworm", "Taenia Solium", "Neurocysticercosis", "Natural History", "Seizures", "Aseptic Meningitis", "Hydrocephalus"], "conditions"=>["Cysticercosis", "Neurocysticercosis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"17030744", "type"=>"BACKGROUND", "citation"=>"Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proano JV, Takayanagui OM, Gonzalez AE, Butman JA, DeGiorgio C, Del Brutto OH, Delgado-Escueta A, Evans CA, Gilman RH, Martinez SM, Medina MT, Pretell EJ, Teale J, Garcia HH. Treatment of neurocysticercosis: current status and future research needs. Neurology. 2006 Oct 10;67(7):1120-7. doi: 10.1212/01.wnl.0000238514.51747.3a."}, {"pmid"=>"21797658", "type"=>"BACKGROUND", "citation"=>"Nash TE, Mahanty S, Garcia HH; Cysticercosis Group in Peru. Corticosteroid use in neurocysticercosis. Expert Rev Neurother. 2011 Aug;11(8):1175-83. doi: 10.1586/ern.11.86."}, {"pmid"=>"21912406", "type"=>"BACKGROUND", "citation"=>"Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135."}, {"pmid"=>"35617367", "type"=>"DERIVED", "citation"=>"Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. eCollection 2022 May."}], "seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1985-I-0127.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient information, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care.", "detailedDescription"=>"Study Description:\n\nThe purpose of this protocol is to follow participants with cysticercosis during and after completion of treatment, to characterize the disease course during both short- and long-term follow-up, assess biomarkers associated with infection and response to treatment, improve diagnostic assays, and explore host-parasite interactions.\n\nPrimary Objective:\n\nThe primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.\n\nSecondary Objectives:\n\n1. To develop novel biomarkers associated with active infection\n2. To further understand host-parasite interactions, including the inflammatory response\n3. Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics\n4. Develop a screening paradigm\n\nPrimary Endpoint:\n\nDescription of clinical presentation, imaging features, morbidity, response to treatment, and outcomes in all forms of NCC.\n\nSecondary Endpoints:\n\n1. Central and peripheral immune cell phenotyping and cytokine measurements\n2. Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing\n3. Biobanking cerebrospinal fluid (CSF), serum, plasma, urine\n4. Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"3 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Male and female participants with NCC (arms 1-5) or epidemiology consistent with the potential for prior exposure to neurocysticercosis (arm 6)", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nArms 1-5 (NCC):\n\n1. Aged 3 years and older.\n2. Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.\n3. Patients with proven or likely NCC\n\nArm 6 (Endemic Exposures):\n\n1. Patient with epidemiologic history compatible with possible exposure to NCC\n2. Aged 18 years and older.\n\nEXCLUSION CRITERIA:\n\nNot applicable"}, "identificationModule"=>{"nctId"=>"NCT00001205", "briefTitle"=>"Natural History of Treated Neurocysticercosis and Long-Term Outcomes", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Natural History of Treated Neurocysticercosis and Long-Term Outcomes", "orgStudyIdInfo"=>{"id"=>"850127"}, "secondaryIdInfos"=>[{"id"=>"85-I-0127"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"1", "description"=>"Male and female participants with NCC (arms 1-5) or epidemiology consistent with the potential for prior exposure to neurocysticercosis (arm 6)"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "centralContacts"=>[{"name"=>"Perla M Adames Castillo, R.N.", "role"=>"CONTACT", "email"=>"perla.adamescastillo@nih.gov", "phone"=>"(301) 402-8495"}, {"name"=>"Elise M O'Connell, M.D.", "role"=>"CONTACT", "email"=>"oconnellem@mail.nih.gov", "phone"=>"(301) 761-5413"}], "overallOfficials"=>[{"name"=>"Elise M O'Connell, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
