{
  "FullStudy":{
    "Rank":218094,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512810",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11-GYN-130"
          },
          "Organization":{
            "OrgFullName":"University of Kentucky",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer",
          "OfficialTitle":"Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2020",
          "OverallStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 28, 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 28, 2021",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 8, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 13, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Frederick R. Ueland, M.D.",
            "ResponsiblePartyInvestigatorTitle":"Professor, Obstetrics and Gynecology",
            "ResponsiblePartyInvestigatorAffiliation":"University of Kentucky"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Frederick R. Ueland, M.D.",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Endometrial Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Endometrial",
              "Cancer",
              "Intraoperative Consultation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"200",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Low-risk for nodal involvement",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"No lymphadenectomy recommended"
              },{
                "ArmGroupLabel":"High-risk for nodal involvement",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Lymphadenectomy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Lymphadenectomy",
                "InterventionDescription":"Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "High-risk for nodal involvement"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Recurrence-free survival",
                "PrimaryOutcomeDescription":"Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).",
                "PrimaryOutcomeTimeFrame":"24 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy.\nPatients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation.\nPreoperative evaluation to rule-out extra-uterine disease may include CT scan, MRI, or ultrasound. Preoperative imaging is not mandatory for study enrollment.\nPatients may have received prior systemic chemotherapy. Such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present disease.\nPatients must have GOG performance status 0, 1, or 2.\nPatients must have an estimated survival greater than or equal to 3 months\nPatients who have met the pre-entry requirements specified in Section 7.0.\nPatients must have signed an approved informed consent and HIPAA authorization.\n\nExclusion Criteria:\n\nPatients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam.\nPatients who have received previous vaginal, pelvic, or abdominal irradiation.\nPatients who received chemotherapy directed at the present disease.\nPatients who have circumstances that will not permit completion of this study or the required follow-up.\nPatients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments.\nPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years.\nPatients with GOG Performance Grade of 3 or 4.",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Frederick Ueland, M.D.",
                "OverallOfficialAffiliation":"Lucille P. Markey Cancer Center at University of Kentucky",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Kentucky Markey Cancer Center",
                "LocationCity":"Lexington",
                "LocationState":"Kentucky",
                "LocationZip":"40536",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000016889",
                "ConditionMeshTerm":"Endometrial Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014594",
                "ConditionAncestorTerm":"Uterine Neoplasms"
              },{
                "ConditionAncestorId":"D000005833",
                "ConditionAncestorTerm":"Genital Neoplasms, Female"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000014591",
                "ConditionAncestorTerm":"Uterine Diseases"
              },{
                "ConditionAncestorId":"D000005831",
                "ConditionAncestorTerm":"Genital Diseases, Female"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M17818",
                "ConditionBrowseLeafName":"Endometrial Neoplasms",
                "ConditionBrowseLeafAsFound":"Endometrial Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15925",
                "ConditionBrowseLeafName":"Uterine Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7528",
                "ConditionBrowseLeafName":"Genital Neoplasms, Female",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15922",
                "ConditionBrowseLeafName":"Uterine Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7526",
                "ConditionBrowseLeafName":"Genital Diseases, Female",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}