{ "FullStudy":{ "Rank":218189, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511575", "OrgStudyIdInfo":{ "OrgStudyId":"AAML12B3" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"COG-AAML12B3", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Children's Oncology Group" },{ "SecondaryId":"AAML12B3", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Children's Oncology Group" },{ "SecondaryId":"NCI-2012-00111", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"CTRP (Clinical Trial Reporting Program)" } ] }, "Organization":{ "OrgFullName":"Children's Oncology Group", "OrgClass":"NETWORK" }, "BriefTitle":"Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder", "OfficialTitle":"Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder" }, "StatusModule":{ "StatusVerifiedDate":"May 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 13, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 17, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Children's Oncology Group", "LeadSponsorClass":"NETWORK" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Cancer Institute (NCI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer.\n\nPURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.", "DetailedDescription":"OBJECTIVES:\n\nTo compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples).\n\nOUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Leukemia" ] }, "KeywordList":{ "Keyword":[ "childhood acute myeloid leukemia in remission", "childhood acute myeloid leukemia/other myeloid malignancies", "childhood acute megakaryocytic leukemia (M7)" ] } }, "DesignModule":{ "StudyType":"Observational", "PatientRegistry":"No", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Case Control" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Retrospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"60", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "InterventionList":{ "Intervention":[ { "InterventionType":"Genetic", "InterventionName":"RNA analysis" },{ "InterventionType":"Genetic", "InterventionName":"reverse transcriptase-polymerase chain reaction" },{ "InterventionType":"Other", "InterventionName":"laboratory biomarker analysis" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Gene expression levels between DS AMKL and non-DS AMKL patients" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"DISEASE CHARACTERISTICS:\n\nPatients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder\nClinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1\n\nPATIENT CHARACTERISTICS:\n\nPreviously consented to biologic studies\n\nPRIOR CONCURRENT THERAPY:\n\nSee Disease Characteristics", "HealthyVolunteers":"No", "Gender":"All", "MaximumAge":"3 Years", "StdAgeList":{ "StdAge":[ "Child" ] }, "StudyPopulation":"Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jeffrey Taub, MD", "OverallOfficialAffiliation":"Children's Hospital of Michigan", "OverallOfficialRole":"Principal Investigator" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007938", "ConditionMeshTerm":"Leukemia" },{ "ConditionMeshId":"D000007951", "ConditionMeshTerm":"Leukemia, Myeloid" },{ "ConditionMeshId":"D000015470", "ConditionMeshTerm":"Leukemia, Myeloid, Acute" },{ "ConditionMeshId":"D000004314", "ConditionMeshTerm":"Down Syndrome" },{ "ConditionMeshId":"D000009196", "ConditionMeshTerm":"Myeloproliferative Disorders" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000008607", "ConditionAncestorTerm":"Intellectual Disability" },{ "ConditionAncestorId":"D000019954", "ConditionAncestorTerm":"Neurobehavioral Manifestations" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000000015", "ConditionAncestorTerm":"Abnormalities, Multiple" },{ "ConditionAncestorId":"D000000013", "ConditionAncestorTerm":"Congenital Abnormalities" },{ "ConditionAncestorId":"D000025063", "ConditionAncestorTerm":"Chromosome Disorders" },{ "ConditionAncestorId":"D000030342", "ConditionAncestorTerm":"Genetic Diseases, Inborn" },{ "ConditionAncestorId":"D000001855", "ConditionAncestorTerm":"Bone Marrow Diseases" },{ "ConditionAncestorId":"D000006402", "ConditionAncestorTerm":"Hematologic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9528", "ConditionBrowseLeafName":"Leukemia", "ConditionBrowseLeafAsFound":"Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9538", "ConditionBrowseLeafName":"Leukemia, Myeloid", "ConditionBrowseLeafAsFound":"Myeloid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16710", "ConditionBrowseLeafName":"Leukemia, Myeloid, Acute", "ConditionBrowseLeafAsFound":"Acute Myeloid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10732", "ConditionBrowseLeafName":"Myeloproliferative Disorders", "ConditionBrowseLeafAsFound":"Myeloproliferative Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6072", "ConditionBrowseLeafName":"Down Syndrome", "ConditionBrowseLeafAsFound":"Down Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9536", "ConditionBrowseLeafName":"Leukemia, Megakaryoblastic, Acute", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10172", "ConditionBrowseLeafName":"Intellectual Disability", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20410", "ConditionBrowseLeafName":"Neurobehavioral Manifestations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12", "ConditionBrowseLeafName":"Congenital Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14", "ConditionBrowseLeafName":"Abnormalities, Multiple", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21607", "ConditionBrowseLeafName":"Chromosome Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4692", "ConditionBrowseLeafName":"Chromosome Aberrations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M22270", "ConditionBrowseLeafName":"Genetic Diseases, Inborn", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3716", "ConditionBrowseLeafName":"Bone Marrow Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8073", "ConditionBrowseLeafName":"Hematologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4021", "ConditionBrowseLeafName":"Myeloid Leukemia", "ConditionBrowseLeafAsFound":"Myeloid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T181", "ConditionBrowseLeafName":"Acute Myeloid Leukemia", "ConditionBrowseLeafAsFound":"Acute Myeloid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T187", "ConditionBrowseLeafName":"Acute Non Lymphoblastic Leukemia", "ConditionBrowseLeafAsFound":"Acute Myeloid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T1318", "ConditionBrowseLeafName":"Chronic Myeloproliferative Disorders", "ConditionBrowseLeafAsFound":"Myeloproliferative Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T176", "ConditionBrowseLeafName":"Acute Megakaryoblastic Leukemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5714", "ConditionBrowseLeafName":"Transient Myeloproliferative Syndrome", "ConditionBrowseLeafAsFound":"Transient Myeloproliferative Disorder", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }