{
  "FullStudy":{
    "Rank":217730,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517581",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CHLA-Gilsanz-BAT/WAT"
          },
          "Organization":{
            "OrgFullName":"Children's Hospital Los Angeles",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Brown Fat Activity and White Fat Accumulation",
          "OfficialTitle":"Study on the Association Between Brown Adipose Tissue Activation and White Adipose Tissue Accumulation in Successfully Treated Pediatric Malignancy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 24, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 25, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Vicente Gilsanz",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Children's Hospital Los Angeles"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Children's Hospital Los Angeles",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"White and brown adipocytes differ in their expression of hormones, cytokines, and inflammatory factors, and they modulate different biological functions. While white adipose tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead metabolizes fat to produce heat and regulate body temperature. BAT is likely present in all humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered longitudinal assessments of the relation between BAT activity and WAT. Under typical imaging conditions, BAT is detected more frequently in children and teenagers than in adults with malignancy. Since most children with cancer have significantly shorter treatment courses and greater survival rates compared to adult patients, the investigators have the ability to examine the relation of repeated measures of body composition and BAT by selecting pediatric patients. In this study, the investigators will longitudinally examine whether BAT activity is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children successfully treated for pediatric cancer."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hodgkins Lymphoma",
              "Non-hodgkins Lymphoma"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Brown adipose tissue"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Retrospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"32",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Malignant Disease with no visualized BAT",
                "ArmGroupDescription":"Children 18 years or younger who 1) had PET/CT scans with evidence of malignant disease but no metabolically active brown adipose tissue (BAT) at diagnosis and 2) were disease free within 1 year of diagnosis."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up",
                "PrimaryOutcomeTimeFrame":"Baseline and up to 1 year"
              },{
                "PrimaryOutcomeMeasure":"Change from Baseline in Visceral Adipose Tissue Volume at Follow-up",
                "PrimaryOutcomeTimeFrame":"Baseline and up to 1 year"
              },{
                "PrimaryOutcomeMeasure":"Change from Baseline in Presence of Brown Adipose Tissue",
                "PrimaryOutcomeTimeFrame":"Baseline and up to 1 year"
              },{
                "PrimaryOutcomeMeasure":"Change from Baseline in Abdominal Musculature Volume",
                "PrimaryOutcomeTimeFrame":"Baseline and up to 1 year"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change from Baseline in Anthropometric Measures at Follow-up",
                "SecondaryOutcomeDescription":"Age, height, weight and BMI",
                "SecondaryOutcomeTimeFrame":"Baseline and up to 1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients had PET/CT scans with evidence of malignant disease\nPatients had no metabolically active BAT at diagnosis on their PET/CT scan\nPatients were disease free within 1 year of diagnosis\n\nExclusion Criteria:\n\nPatients had PET/CT scans with no evidence of malignant disease\nPatients with metabolically active BAT at diagnosis on their PET/CT scan\nPatients were not disease free within 1 year of diagnosis",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"6 Years",
          "MaximumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          },
          "StudyPopulation":"Pediatric patients with a history of malignancy such that they are required to undergo PET/CT exams.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Vicente Gilsanz, MD, PhD",
                "OverallOfficialAffiliation":"Children's Hospital Los Angeles",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Children's Hospital Los Angeles",
                "LocationCity":"Los Angeles",
                "LocationState":"California",
                "LocationZip":"90027-6062",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"21780237",
                "ReferenceType":"background",
                "ReferenceCitation":"Hamilton G, Smith DL Jr, Bydder M, Nayak KS, Hu HH. MR properties of brown and white adipose tissues. J Magn Reson Imaging. 2011 Aug;34(2):468-73. doi: 10.1002/jmri.22623."
              },{
                "ReferencePMID":"21168855",
                "ReferenceType":"result",
                "ReferenceCitation":"Gilsanz V, Chung SA, Jackson H, Dorey FJ, Hu HH. Functional brown adipose tissue is related to muscle volume in children and adolescents. J Pediatr. 2011 May;158(5):722-6. doi: 10.1016/j.jpeds.2010.11.020. Epub 2010 Dec 18."
              },{
                "ReferencePMID":"22048045",
                "ReferenceType":"result",
                "ReferenceCitation":"Gilsanz V, Smith ML, Goodarzian F, Kim M, Wren TA, Hu HH. Changes in brown adipose tissue in boys and girls during childhood and puberty. J Pediatr. 2012 Apr;160(4):604-609.e1. doi: 10.1016/j.jpeds.2011.09.035. Epub 2011 Nov 1."
              },{
                "ReferencePMID":"21404026",
                "ReferenceType":"result",
                "ReferenceCitation":"Gilsanz V, Chung SA, Kaplowitz N. Differential effect of gender on hepatic fat. Pediatr Radiol. 2011 Sep;41(9):1146-53. doi: 10.1007/s00247-011-2021-7. Epub 2011 Mar 15."
              },{
                "ReferencePMID":"21245691",
                "ReferenceType":"result",
                "ReferenceCitation":"Hu HH, Chung SA, Nayak KS, Jackson HA, Gilsanz V. Differential computed tomographic attenuation of metabolically active and inactive adipose tissues: preliminary findings. J Comput Assist Tomogr. 2011 Jan-Feb;35(1):65-71. doi: 10.1097/RCT.0b013e3181fc2150."
              },{
                "ReferencePMID":"22456659",
                "ReferenceType":"derived",
                "ReferenceCitation":"Chalfant JS, Smith ML, Hu HH, Dorey FJ, Goodarzian F, Fu CH, Gilsanz V. Inverse association between brown adipose tissue activation and white adipose tissue accumulation in successfully treated pediatric malignancy. Am J Clin Nutr. 2012 May;95(5):1144-9. doi: 10.3945/ajcn.111.030650. Epub 2012 Mar 28."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008223",
                "ConditionMeshTerm":"Lymphoma"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000008232",
                "ConditionAncestorTerm":"Lymphoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000008206",
                "ConditionAncestorTerm":"Lymphatic Diseases"
              },{
                "ConditionAncestorId":"D000007160",
                "ConditionAncestorTerm":"Immunoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9803",
                "ConditionBrowseLeafName":"Lymphoma",
                "ConditionBrowseLeafAsFound":"Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8334",
                "ConditionBrowseLeafName":"Hodgkin Disease",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9808",
                "ConditionBrowseLeafName":"Lymphoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9786",
                "ConditionBrowseLeafName":"Lymphatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8789",
                "ConditionBrowseLeafName":"Immunoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3556",
                "ConditionBrowseLeafName":"Lymphosarcoma",
                "ConditionBrowseLeafAsFound":"Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T2828",
                "ConditionBrowseLeafName":"Hodgkin Lymphoma",
                "ConditionBrowseLeafAsFound":"Hodgkin lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}