Nctid:
NCT00001506
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M15674", "name"=>"Skin Diseases", "asFound"=>"Dermatologic Disease", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>500}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"1996-08-22", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10-23", "lastUpdateSubmitDate"=>"2024-11-08", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Provide clinical material", "timeFrame"=>"Ongoing", "description"=>"Provide clinical material"}, {"measure"=>"Natural history of selected dermatologic diseases", "timeFrame"=>"Ongoing", "description"=>"Natural history of selected dermatologic diseases"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Natural History", "Consultation", "Standard Therapy", "Standard Tests", "Training"], "conditions"=>["Dermatologic Diseases", "Systemic Diseases With Cutaneous Manifestations"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1996-AR-0102.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients' diagnosis, response to treatment, and/or disease progression.", "detailedDescription"=>"Background\n\nThis is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. This protocol was developed to allow subject enrollment for teaching purposes and to allow for second opinions regarding relatively complicated patients, and to allow for evaluation of non-invasive tools for the diagnosis and monitoring of cutaneous manifestations. This protocol promotes a critical link between the NCI, CCR Dermatology Branch and the local and national extramural medical communities.\n\nObjectives:\n\n* To provide clinical material to fulfill the educational mission of the Dermatology Branch.\n* To learn about the natural history of selected dermatologic diseases.\n\nEligibility:\n\nAll subjects regardless of age, gender, or racial/ethnic group with dermatologic disease or systemic disease with cutaneous manifestations.\n\nDesign:\n\nPatients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients diagnosis, response to treatment, and/or disease progression. Non-invasive tools may be used as part of the examination and assessment of cutaneous manifestations of disease."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with dermatologic diseases and systemic diseases with cutaneous manifestations", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nPatients of any age (only viable neonates will enroll in the study), of both genders, and all racial/ethnic groups with dermatologic diseases or systemic diseases with cutaneous manifestations that will help the Branch fulfill the objectives.\n\nWomen who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child.\n\nPatients must have a referring physician who will continue to assume primary medical responsibility of care for the patient during and after enrollment in this protocol.\n\nEXCLUSION CRITERIA:\n\nAny participant who, in the investigator s opinion, would be unable to comply with study requirements or for whom participation may pose a greater medical risk."}, "identificationModule"=>{"nctId"=>"NCT00001506", "briefTitle"=>"Evaluation and Treatment of Patients With Dermatologic Diseases", "nctIdAliases"=>["NCT00019149"], "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Evaluation and Treatment of Subjects With Dermatologic Diseases", "orgStudyIdInfo"=>{"id"=>"960102"}, "secondaryIdInfos"=>[{"id"=>"96-AR-0102"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients", "description"=>"With dermatologic diseases and systemic diseases with cutaneous manifestations"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)", "role"=>"CONTACT", "email"=>"ccopr@nih.gov", "phone"=>"800-411-1222", "phoneExt"=>"TTY dial 711"}], "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "centralContacts"=>[{"name"=>"Kelli A Karacki, P.A.-C", "role"=>"CONTACT", "email"=>"kelli.karacki@nih.gov", "phone"=>"(301) 402-7806"}, {"name"=>"Edward W Cowen, M.D.", "role"=>"CONTACT", "email"=>"ec176r@nih.gov", "phone"=>"(301) 827-2328"}], "overallOfficials"=>[{"name"=>"Edward W Cowen, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"Protocol is silent on individual participant data (IPD) sharing plan."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
