{ "FullStudy":{ "Rank":218263, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510600", "OrgStudyIdInfo":{ "OrgStudyId":"ANBL12B5" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"COG-ANBL12B5", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Children's Oncology Group" },{ "SecondaryId":"CDR0000722061", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Clinical Trials.gov" },{ "SecondaryId":"ANBL12B5", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Children's Oncology Group" },{ "SecondaryId":"NCI-2012-00109", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"CTRP (Clinical Trial Reporting Program)" } ] }, "Organization":{ "OrgFullName":"Children's Oncology Group", "OrgClass":"NETWORK" }, "BriefTitle":"Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma", "OfficialTitle":"Alternative Lengthening of Telomeres (ALT) in Neuroblastoma" }, "StatusModule":{ "StatusVerifiedDate":"May 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 17, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 19, 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 and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This research trial studies biomarkers in samples from patients with high-risk neuroblastoma.", "DetailedDescription":"OBJECTIVES:\n\nTo establish telomere length measurement by quantitative polymerase chain reaction (qPCR) as an alternative lengthening of telomeres (ALT) detection method in neuroblastoma (NB).\nTo determine the frequency of ALT in high-risk NB and the characteristics of ALT+ NB.\nTo establish C-circle (extra-chromosomal telomeric DNA circles) level as a marker of ALT activity in NB.\nTo evaluate the prognostic significance of ALT in NB.\nTo evaluate the utility of the C-circle assay for the detection of circulating tumor DNA in NB patients with an ALT+ tumor.\n\nOUTLINE: Archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and C-circle levels by PCR. Results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Neuroblastoma" ] }, "KeywordList":{ "Keyword":[ "stage 4S neuroblastoma", "localized resectable neuroblastoma", "localized unresectable neuroblastoma", "recurrent neuroblastoma", "regional neuroblastoma" ] } }, "DesignModule":{ "StudyType":"Observational", "PatientRegistry":"No", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Retrospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"99", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "InterventionList":{ "Intervention":[ { "InterventionType":"Genetic", "InterventionName":"DNA analysis" },{ "InterventionType":"Genetic", "InterventionName":"polymerase chain reaction" },{ "InterventionType":"Other", "InterventionName":"laboratory biomarker analysis" },{ "InterventionType":"Other", "InterventionName":"medical chart review" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method" },{ "PrimaryOutcomeMeasure":"Frequency and characteristics of ALT in high-risk NB" },{ "PrimaryOutcomeMeasure":"C-circle level as a marker of ALT activity in NB" },{ "PrimaryOutcomeMeasure":"Prognostic value of ALT" },{ "PrimaryOutcomeMeasure":"C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"DISEASE CHARACTERISTICS:\n\nSnap-frozen neuroblastoma (NB) tumors collected at diagnosis (Objectives 1 to 3)\n\nHigh-risk stage 3 or 4 NB AND MYCN non-amplified, i.e., exclude stage 4 infants who are not high-risk\n\nUp to five high-risk (> 18 months, unfavorable histology) stage 3/MYCN non-amplified tumors\nPatients preferably treated on protocol COG-A3973 or similar protocols with myeloablative therapy\nAt least 3 years of follow-up for those with no event (current evidence suggests that ALT+ NBs often relapse late, i.e., 2 years or longer from diagnosis)\n\nNB tumor DNA collected at diagnosis (Objectives 2 & 3)\n\nHigh-risk stage 3 or 4 NB as for Objective 1, except for MYCN status\nStage 4 tumors are preferred; may include up to seven high-risk stage 3 tumors with similar distribution of MYCN-amplified and non-amplified tumors\n\nFrozen serum from NB patients (Objective 5; 2nd stage of project)\n\nPaired serum obtained at diagnosis from patients with ALT+ or ALT- tumors identified in Objective 2\n\nPATIENT CHARACTERISTICS:\n\nNot specified\n\nPRIOR CONCURRENT THERAPY:\n\nSee Disease Characteristics", "HealthyVolunteers":"No", "Gender":"All", "MaximumAge":"30 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] }, "StudyPopulation":"Patients diagnosed with neuroblastoma.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Loretta Lau, MD", "OverallOfficialAffiliation":"Sydney Children's Hospitals Network", "OverallOfficialRole":"Principal Investigator" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009447", "ConditionMeshTerm":"Neuroblastoma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000018241", "ConditionAncestorTerm":"Neuroectodermal Tumors, Primitive, Peripheral" },{ "ConditionAncestorId":"D000018242", "ConditionAncestorTerm":"Neuroectodermal Tumors, Primitive" },{ "ConditionAncestorId":"D000018302", "ConditionAncestorTerm":"Neoplasms, Neuroepithelial" },{ "ConditionAncestorId":"D000017599", "ConditionAncestorTerm":"Neuroectodermal Tumors" },{ "ConditionAncestorId":"D000009373", "ConditionAncestorTerm":"Neoplasms, Germ Cell and Embryonal" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009380", "ConditionAncestorTerm":"Neoplasms, Nerve Tissue" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10974", "ConditionBrowseLeafName":"Neuroblastoma", "ConditionBrowseLeafAsFound":"Neuroblastoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18428", "ConditionBrowseLeafName":"Neuroectodermal Tumors", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18971", "ConditionBrowseLeafName":"Neuroectodermal Tumors, Primitive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18970", "ConditionBrowseLeafName":"Neuroectodermal Tumors, Primitive, Peripheral", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19030", "ConditionBrowseLeafName":"Neoplasms, Neuroepithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10901", "ConditionBrowseLeafName":"Neoplasms, Germ Cell and Embryonal", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10903", "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10908", "ConditionBrowseLeafName":"Neoplasms, Nerve Tissue", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4112", "ConditionBrowseLeafName":"Neuroblastoma", "ConditionBrowseLeafAsFound":"Neuroblastoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T4119", "ConditionBrowseLeafName":"Neuroepithelioma", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }