Nctid:
NCT00001505
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M15674", "name"=>"Skin Diseases", "asFound"=>"Dermatologic Disease", "relevance"=>"HIGH"}, {"id"=>"M5049", "name"=>"Blister", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>304}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"1998-01-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04-09", "lastUpdateSubmitDate"=>"2024-12-20", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases", "timeFrame"=>"Ongoing", "description"=>"Collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Biopsy", "Research", "Autoimmune", "Blistering", "Compensation", "Natural History"], "conditions"=>["Healthy Volunteer", "Dermatologic Diseases", "Systemic Diseases"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1996-AR-0097.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Background:\n\n-This protocol is concerned with the acquisition of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin diseases to support the basic science and clinical research activities of the Dermatology Branch and other intramural Laboratories and Branches at the NIH Clinical Research Center.\n\nObjectives:\n\n(Primary)\n\n-To allow collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases as needed to support the research activities of our Branch and other Laboratories and Branches.\n\nEligibility:\n\n* Healthy individuals (including employees and other patients) and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups.\n* Patient volunteers must be willing to undergo blood drawing and/or skin/mucosal biopsies.\n\nDesign:\n\n-This is dependent upon the particular investigation for which these samples are needed.", "detailedDescription"=>"Background:\n\n-This protocol is concerned with the acquisition of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin diseases to support the basic science and clinical research activities of the Dermatology Branch and other intramural Laboratories and Branches at the NIH Clinical Research Center.\n\nObjectives:\n\n(Primary)\n\n-To allow collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases as needed to support the research activities of our Branch and other Laboratories and Branches.\n\nEligibility:\n\n* Healthy individuals (including employees and other patients) and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups.\n* Patient volunteers must be willing to undergo blood drawing and/or skin/mucosal samples/monitoring.\n\nDesign:\n\n-This is dependent upon the particular investigation for which these samples are needed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Healthy volunteers or patients with selected skin diseases", "healthyVolunteers"=>true, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nHealthy individuals (including employees and other patients), and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups.\n\nPatient volunteers must be willing to undergo blood drawing and/or skin/mucosal sampling/monitoring to include non-invasive skin samples.\n\nEXCLUSION CRITERIA:\n\nStrong family history and/or evidence of keloid formation following surgery or trauma.\n\nChildren under the age of 18 years.\n\nPregnant women"}, "identificationModule"=>{"nctId"=>"NCT00001505", "briefTitle"=>"The Acquisition of Blood and Skin Samples From Normal Volunteers to Support Research Activities on Dermatologic Diseases", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"The Acquisition of Blood and Skin Samples From Patient Volunteers to Support Research Activities on Dermatologic and Other Diseases", "orgStudyIdInfo"=>{"id"=>"960097"}, "secondaryIdInfos"=>[{"id"=>"96-AR-0097"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"1/Single Cohort", "description"=>"Healthy individuals (including employees and other patients) and patients with selected skin or other diseases"}]}, "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"=>"Heidi H Kong, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}