{
  "FullStudy":{
    "Rank":218302,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510067",
          "OrgStudyIdInfo":{
            "OrgStudyId":"805758"
          },
          "Organization":{
            "OrgFullName":"University of Pennsylvania",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus",
          "OfficialTitle":"Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2019",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2025",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2025",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 13, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 10, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 11, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Victoria Werth",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"University of Pennsylvania"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Pennsylvania",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).",
          "DetailedDescription":"The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus).\n\nThe CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications.\n\nThe CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Cutaneous Lupus Erythematosus"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "CLE",
              "Lupus",
              "Lupus Erythematosus"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Blood, Skin Tissue Biopsies"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"400",
            "EnrollmentType":"Anticipated"
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older.\n\nExclusion Criteria:\n\nAll subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Subjects will be recruited from among the patients seen at the Autoimmune Skin Disease Clinic at the Hospital of the University of Pennsylvania and other collaborating centers.",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Victoria P Werth, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"215-615-2940",
                "CentralContactEMail":"werth@mail.med.upenn.edu;"
              },{
                "CentralContactName":"Joyce Okawa, R.N",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"215-615-2940",
                "CentralContactEMail":"Joyce.Okawa@uphs.upenn.edu"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Victoria Werth, M.D.",
                "OverallOfficialAffiliation":"University of Pennsylvania",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hospital of the University of Pennsylvania",
                "LocationStatus":"Recruiting",
                "LocationCity":"Philadelphia",
                "LocationState":"Pennsylvania",
                "LocationZip":"19104",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Victoria P Werth, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"215-898-0168"
                    }
                  ]
                }
              },{
                "LocationFacility":"University of Texas Southwestern",
                "LocationStatus":"Recruiting",
                "LocationCity":"Dallas",
                "LocationState":"Texas",
                "LocationZip":"75390",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Benjamin Chong",
                      "LocationContactRole":"Contact"
                    }
                  ]
                }
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008180",
                "ConditionMeshTerm":"Lupus Erythematosus, Systemic"
              },{
                "ConditionMeshId":"D000008178",
                "ConditionMeshTerm":"Lupus Erythematosus, Cutaneous"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003240",
                "ConditionAncestorTerm":"Connective Tissue Diseases"
              },{
                "ConditionAncestorId":"D000001327",
                "ConditionAncestorTerm":"Autoimmune Diseases"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              },{
                "ConditionAncestorId":"D000012871",
                "ConditionAncestorTerm":"Skin Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9758",
                "ConditionBrowseLeafName":"Lupus Erythematosus, Cutaneous",
                "ConditionBrowseLeafAsFound":"Cutaneous Lupus Erythematosus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9760",
                "ConditionBrowseLeafName":"Lupus Erythematosus, Systemic",
                "ConditionBrowseLeafAsFound":"Lupus Erythematosus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5047",
                "ConditionBrowseLeafName":"Connective Tissue Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3210",
                "ConditionBrowseLeafName":"Autoimmune Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14257",
                "ConditionBrowseLeafName":"Skin Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T1693",
                "ConditionBrowseLeafName":"Cutaneous Lupus Erythematosus",
                "ConditionBrowseLeafAsFound":"Cutaneous Lupus Erythematosus",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}