{ "FullStudy":{ "Rank":217572, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519648", "OrgStudyIdInfo":{ "OrgStudyId":"RIFI" }, "Organization":{ "OrgFullName":"National Hematological Society, Russia", "OrgClass":"OTHER" }, "BriefTitle":"A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation", "OfficialTitle":"A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation" }, "StatusModule":{ "StatusVerifiedDate":"July 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 26, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 18, 2014", "ResultsFirstSubmitQCDate":"June 18, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 18, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 18, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 25, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"National Hematological Society, Russia", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.", "DetailedDescription":"This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Invasive Fungal Infections" ] }, "KeywordList":{ "Keyword":[ "Invasive fungal infection", "Acute leukemia (AL)", "Hematopoietic stem cell transplantation", "Antifungal stewardship", "Neutropenia", "Hematological malignancies" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"808", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Acute leukemia patients", "ArmGroupDescription":"Patients with de novo or relapsed acute myeloid and lymphoid leukemia" },{ "ArmGroupLabel":"Allo- or auto- transplant recipients" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The Rate of Invasive Fungal Infections", "PrimaryOutcomeDescription":"Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.", "PrimaryOutcomeTimeFrame":"6 month" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy\nAll newly allogeneic or autologous transplant recipients during the study period", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"1 Year", "MaximumAge":"95 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] }, "StudyPopulation":"This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.", "SamplingMethod":"Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Galina A Klyasova", "OverallOfficialAffiliation":"National Research Center for Hematology", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"National Hematological Society", "LocationCity":"Moscow", "LocationZip":"119021", "LocationCountry":"Russian Federation" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Acute Leukemia Patients", "FlowGroupDescription":"Patients with de novo or relapsed acute myeloid and lymphoid leukemia" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Allo- or Auto- Transplant Recipients" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"502" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"306" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"502" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"306" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Acute Leukemia Patients", "BaselineGroupDescription":"Patients with de novo or relapsed acute myeloid and lymphoid leukemia" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Allo- or Auto- Transplant Recipients" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"502" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"306" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"808" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"42", "BaselineMeasurementSpread":"1-79", "BaselineMeasurementLowerLimit":"1", "BaselineMeasurementUpperLimit":"79" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"37", "BaselineMeasurementSpread":"1-66", "BaselineMeasurementLowerLimit":"1", "BaselineMeasurementUpperLimit":"66" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"40", "BaselineMeasurementSpread":"1-79", "BaselineMeasurementLowerLimit":"1", "BaselineMeasurementUpperLimit":"79" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"69" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"55" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"124" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"389" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"250" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"639" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"44" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"45" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"261" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"150" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"411" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"241" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"156" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"397" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Russian Federation", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"502" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"306" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"808" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"The Rate of Invasive Fungal Infections", "OutcomeMeasureDescription":"Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6 month", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Acute Leukemia Patients", "OutcomeGroupDescription":"Patients with de novo or relapsed acute myeloid and lymphoid leukemia" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Allo- or Auto- Transplant Recipients", "OutcomeGroupDescription":"Allo- or auto- transplant recipients" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"502" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"306" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.007", "OutcomeAnalysisStatisticalMethod":"Chi-squared", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.872", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.178", "OutcomeAnalysisCIUpperLimit":"2.977", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.237" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"The study was observational and the adverse events were not evaluated", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Acute Leukemia Patients", "EventGroupDescription":"Patients with de novo or relapsed acute myeloid and lymphoid leukemia", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" },{ "EventGroupId":"EG001", "EventGroupTitle":"Allo- or Auto- Transplant Recipients", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Professor Galina A Klyasova", "PointOfContactOrganization":"National Hematological Society", "PointOfContactEMail":"klyasova.g@blood.ru", "PointOfContactPhone":"+7(495)6125181" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007239", "ConditionMeshTerm":"Infection" },{ "ConditionMeshId":"D000003141", "ConditionMeshTerm":"Communicable Diseases" },{ "ConditionMeshId":"D000009181", "ConditionMeshTerm":"Mycoses" },{ "ConditionMeshId":"D000072742", "ConditionMeshTerm":"Invasive Fungal Infections" },{ "ConditionMeshId":"D000007938", "ConditionMeshTerm":"Leukemia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafAsFound":"Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafAsFound":"Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9528", "ConditionBrowseLeafName":"Leukemia", "ConditionBrowseLeafAsFound":"Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M19898", "ConditionBrowseLeafName":"Hematologic Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11026", "ConditionBrowseLeafName":"Neutropenia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10719", "ConditionBrowseLeafName":"Mycoses", "ConditionBrowseLeafAsFound":"Fungal Infections", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M1099", "ConditionBrowseLeafName":"Invasive Fungal Infections", "ConditionBrowseLeafAsFound":"Invasive Fungal Infections", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2618", "ConditionBrowseLeafName":"Granulocytopenia", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }