{
  "FullStudy":{
    "Rank":217647,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518673",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2010/708"
          },
          "Organization":{
            "OrgFullName":"University Ghent",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.",
          "OfficialTitle":"National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.",
          "Acronym":"PedCTBe"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2014",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2015",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2015",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 4, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 5, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Ghent",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Federal Agency for Nuclear Control, Belgium",
                "CollaboratorClass":"OTHER_GOV"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays. Pediatric patients are known to be very radiosensitive with respect to radiation induced cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can be detected. The technique will be applied in a multicenter setting for evaluation of X-effects induced by a computed tomography examination in a population of pediatric patients. To this end a blood sample will be taken from the patients before and after the examination."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pediatric Patients Undergoing a Computed Tomography Examination"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Blood lymphocytes"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"120",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"X-rays",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Blood test"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Blood test",
                "InterventionDescription":"Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "X-rays"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"X-ray induced genetic effects in pediatric patients directly after a computed tomography scan.",
                "PrimaryOutcomeDescription":"Assessment of γ -H2AX foci in peripheral blood lymphocytes.",
                "PrimaryOutcomeTimeFrame":"Within 30 min after the computed tomography examination."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\npediatric patients wearing a catheter\n\nExclusion Criteria:",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"12 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          },
          "StudyPopulation":"Pediatric patients undergoing computed tomography are exposed to a relatively high dose of X-rays.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Peter Smeets, MD",
                "CentralContactRole":"Contact",
                "CentralContactEMail":"peter.smeets@uzgent.be"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Peter Smeets, MD",
                "OverallOfficialAffiliation":"University Hospital, Ghent",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Hospital Ghent",
                "LocationStatus":"Recruiting",
                "LocationCity":"Ghent",
                "LocationZip":"9000",
                "LocationCountry":"Belgium",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Peter Smeets, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactEMail":"peter.smeets@uzgent.be"
                    }
                  ]
                }
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Related Info",
                "SeeAlsoLinkURL":"http://www.uzgent.be"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}