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  1. StudyEvent: COG AALL08B1 OPEN Registration Worksheet
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Stratification
CL.1
Code List
ADVL0912 Stratum
CL Item
Patients With Relapsed/refractory Solid Tumors (including Cns Tumors), And Anaplastic Large Cell Lymphoma (alcl) Without Bone Marrow Involvement (Patients with relapsed/refractory solid tumors (including CNS tumors), and anaplastic large cell lymphoma (ALCL) WITHOUT bone marrow involvement)
CL Item
Patients With Relapsed/refractory Solid Tumors (including Cns Tumors), And Anaplastic Large Cell Lymphoma (alcl) With Or Without Bone Marrow Involvement (Patients with relapsed/refractory solid tumors (including CNS tumors), and anaplastic large cell lymphoma (ALCL) WITH OR WITHOUT bone marrow involvement)
CL Item
Patients With Relapsed Or Refractory Neuroblastoma, With Or Without Bone Marrow Involvement, Who Are Not Eligible For Part A1 Or A2 Or Cannot Enroll On Part A1 Because Of Stratum Suspension Or Lack Of Available Slots (Patients with relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of stratum suspension or lack of available slots)
TreatmentBeginDate
Item
Treatment Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Item Group
Patient Criteria
ALLNeuroblastomaDiagnosisInd-2
Item
Does the patient have newly diagnosed acute leukemia suspected to be acute lymphoblastic leukemia (See Section 3.2.3 for eligibility requirements)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
BoneMarrowPre-StudyEvaluationInd-2
Item
Did patient have a bone marrow evaluation just prior to study entry (See section 3.2 and 3.2.1 for eligibility requirements)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C38010 (NCI Thesaurus Property-2)
C1527048 (UMLS 2011AA Property-2)
PatientAgeEligibilityDeterminationInd-2
Item
Was the patient in the indicated age range at time of study enrollment (To be eligible, patient must be greater than 12 months and less than or equal to 21 years of age at the time of study enrollment.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
PathologySpecimenCentralReviewerSubmissionInd-2
Item
Will all required diagnostic samples be sent to the local and COG Reference Laboratories as per indicated documents (Indicated documents include Appendix I-V. Adequate samples MUST be sent to a COG-APPROVED Cytogenetic Laboratory and COG Reference Laboratory per Section 4.1 so that the data needed for risk-adjusted post-Induction therapy are available)
boolean
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
C51807 (NCI Thesaurus Property-2)
C1707338 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientChemotherapyEligibilityDeterminationInd-4
Item
Has the patient received Prior Treatment with cytotoxic chemotherapy (Patients may not have received prior cytotoxic therapy except for intrathecal chemotherapy or steroids See sections 3.2.6 and 3.3.1. PATIENTS MUST BE ENROLLED ON AALL08B1 BEFORE TREATMENT BEGINS with the exception of the first dose of intrathecal chemotherapy or selected cases of steroid pretreatment)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
PersonLeukemiaDiseaseorDisorderClinicalTrialParticipationInd-2
Item
Does patient have the indicated type of leukemia (Indicated type of leukemia is secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C3161 (NCI Thesaurus Property-3)
C0023418 (UMLS 2011AA Property-3)
C71104 (NCI Thesaurus Property-4)
C0008976 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
StudyCompleteRequirementsInd-2
Item
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must be met)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
Item Group
Consent For Research Studies
PatientPharmacokineticStudyConsentInd-2
Item
Was consent signed for Pharmacokinetics
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C49663 (NCI Thesaurus Property-2)
C0201734 (UMLS 2011AA Property-2)
SpecimenRelatedGeneticResearchConsentInd-2
Item
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
boolean
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property-3)
C0314603 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudyTissueSpecimenConsentInd-2
Item
Patient consents to tissue submission
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudyBloodSpecimenConsentInd-2
Item
Patient consents to blood submission
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ResponsiblePersonSignatureText
Item
Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
Item Group
Exclusion Criteria
PregnancyTestPerformedInd-2
Item
Pregnancy test done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
PatientPregnancyInd-2
Item
Is patient pregnant
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
NursingMotherInd-3
Item
Is patient nursing
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25189 (NCI Thesaurus Property)
C0026591 (UMLS 2011AA Property)
C16926 (NCI Thesaurus ObjectClass)
C0028677 (UMLS 2011AA ObjectClass)
Item
Has patient agreed to use an effective contraceptive method
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
CL.20
Code List
Has patient agreed to use an effective contraceptive method
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a, Patient Is Not Of Reproductive Potential (N/A, patient is not of reproductive potential)
CorticosteroidAdministrationInd-3
Item
Is the patient receiving corticosteroids?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CorticosteroidStableLowerDoseAdministeredIndicator
Item
Has patient been on a stable or decreasing dose of corticosteroids for the indicated period
boolean
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C30103 (NCI Thesaurus Property)
C0205360 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property-2)
C0178602 (UMLS 2011AA Property-2)
C86568 (NCI Thesaurus Property-3)
C2003888 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CancerTreatmentConcurrentAdministeredInd-2
Item
Is patient currently receiving any other anticancer or experimental drug therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C16212 (NCI Thesaurus ObjectClass)
C0920425 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
PatientInfectionInd-2
Item
Does patient have an uncontrolled infection?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
PatientClinicalTrialSafetyComplianceInd-2
Item
Is patient, in the opinion of the investigator, able to comply with the safety monitoring requirements of the study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C25194 (NCI Thesaurus Property-2)
C60828 (NCI Thesaurus Property-3)
C0036043 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4SubstrateDomainEligibilityDeterminationInd-2
Item
Is patient receiving CYP3A4 substrates with narrow therapeutic indices
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17573 (NCI Thesaurus Property-2)
C1142644 (UMLS 2011AA Property-2)
C14073 (NCI Thesaurus Property-3)
C1515032 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4InhibitionAgentEligibilityDeterminationInd-2
Item
Did patient receive CYP3A4 inhibitor during the indicated period
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C17573 (NCI Thesaurus Property-3)
C1142644 (UMLS 2011AA Property-3)
C42791 (NCI Thesaurus Property-4)
C0021469 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4InductionAgentEligibilityDeterminationInd-2
Item
Did patient receive CYP3A4 inducer during the indicated period
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C61367 (NCI Thesaurus Property)
C0205263 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C17573 (NCI Thesaurus Property-4)
C1142644 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Organ Function - Non Hematological
PatientRenalFunctionRequiredInd-2
Item
Does patient have adequate renal function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Creatinine Clearance Date
Item
Date of Creatinine Clearance
date
C25164 (NCI Thesaurus ValueDomain)
C20200 (NCI Thesaurus Property)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1])
GFR
Item
What is the GFR for the indicated period (ml/min/1.73m2)
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C90505 (NCI Thesaurus Property-2)
C0017654 (UMLS CUI [1])
PatientLiverFunctionRequiredInd-2
Item
Does patient have adequate liver function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Bilirubin, total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1])
Bilirubin, total ULN
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201836 (UMLS CUI [1])
Albumin
Item
Albumin
float
C20200 (NCI Thesaurus Property)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201838 (UMLS CUI [1])
PatientSwallowingAssessmentInd-2
Item
Is patient able to swallow capsules or a liquid suspension
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)
Item Group
Organ Function - Hematological
BoneMarrowInvolvementInd-3
Item
Does patient have bone marrow involvement
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
PatientBoneMarrowFunctionRequiredInd-2
Item
Does patient have adequate bone marrow function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
HematologySpecimenCollectedDate
Item
Lab, Hematology, Sample Collection Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0023508 (UMLS CUI [1])
Neutrophil count
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0200633 (UMLS CUI [1])
LaboratoryProcedureSegmentedNeutrophilOutcomePercentageValue
Item
Segs
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C36719 (NCI Thesaurus Property-2)
C0229640 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureNeutrophilBandFormCountResultPercentageValue
Item
Bands
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64830 (NCI Thesaurus Property-2)
C1882076 (UMLS 2011AA Property-2)
C49100 (NCI Thesaurus ValueDomain)
C1704610 (UMLS 2011AA ValueDomain)
Platelets
Item
Peripheral Platelet Count
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI [1])
Item
Were transfusions given
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)
CL.34
Code List
Were transfusions given
CL Item
No Transfusion (No)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Transfusion With Platelets And Red Blood Cells (Yes, both)
CL Item
Transfusion With Platelets (Yes, platelets)
CL Item
Transfusion With Red Blood Cells (Yes, red blood cells)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Tests performed during indicated period
Item
Were tests to determine eligibility performed during the indicated period
boolean
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
PersonGreaterBodySurfaceAreaClinicalTrialEligibilityCriteriaInd-2
Item
Does patient have a BSA (body surface area) greater than or equal to the indicated value (BSA Dose Level 0 and 1 only: To be eligible, patients must have a BSA >= 0.4 at the time of study enrollment. - )
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C61421 (NCI Thesaurus Property)
C1704243 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25157 (NCI Thesaurus Property-3)
C0005902 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BSA
Item
Body surface area
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI [1])
Tumor confirmed histologically
Item
Does patient have histologic verification of the malignancy at the indicated time point
boolean
C25180 (NCI Thesaurus ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C1271092 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
NeuroblastomaDiagnosisInd-2
Item
Does patient have neuroblastoma
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C3270 (NCI Thesaurus ObjectClass)
C0027819 (UMLS 2011AA ObjectClass)
AnaplasticLargeCellLymphomaDiagnosisInd-2
Item
Does patient have ALCL (anaplastic large cell lymphoma)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3720 (NCI Thesaurus ObjectClass)
C0206180 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PersonALKGeneAbnormalityClinicalTrialEligibilityCriteriaInd-2
Item
Does patient have histologic verification of the malignancy at the indicated time point
boolean
C25190 (NCI Thesaurus ObjectClass)
C9440 (NCI Thesaurus Property)
C16112 (NCI Thesaurus Property-2)
C38184 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
ALK molecular abnormality verified
Item
Did patient have ALK molecular abnormality verified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
boolean
C25190 (NCI Thesaurus ObjectClass)
C9440 (NCI Thesaurus Property)
C16112 (NCI Thesaurus Property-2)
C45513 (NCI Thesaurus Property-3)
C38184 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1332080 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1711411 (UMLS CUI [1,3])
Histologically verified malignancy
Item
Does patient have histologic verification of the malignancy at the indicated time point
boolean
C25190 (NCI Thesaurus ObjectClass)
C38014 (NCI Thesaurus Property)
C3270 (NCI Thesaurus Property-2)
C16112 (NCI Thesaurus Property-3)
C0699753 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1271092 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
Measurable Disease
Item
Does patient meet the disease status requirement (To be eligible, patient must have either measurable and/or evaluable disease. - - Note: See Protocol Sections 12.2 and 12.3 and 12.6 for definitions.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C8507 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI [1])
No other therapy available
Item
Is patient's current disease state one for which there is no known curative therapy available or therapy proven to prolong survival with an acceptable quality of life
boolean
C25190 (NCI Thesaurus ObjectClass)
C49487 (NCI Thesaurus Property)
C15697 (NCI Thesaurus Property-2)
C44275 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C25374 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0418967 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
Item
Karnofsky Status
integer
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0206065 (UMLS CUI [1])
CL.46
Code List
Karnofsky Status
CL Item
Normal - no complaints; no evidence of disease. (100)
CL Item
Able to carry on normal activity; minor sign or symptoms of disease. (90)
CL Item
Normal activity; minor sign of symptoms of disease. (80)
CL Item
Care for self; unable to carry on normal activity or to do active work. (70)
CL Item
Requires occasional assistance, but is able to care for most personal needs. (60)
CL Item
Requires considerable assistance and frequent medical care. (50)
CL Item
Disabled; requires special care and assistance. (40)
CL Item
Severely disabled; hospital admission is indicated although death not imminent. (30)
CL Item
Very sick; hospital admission is necessary; active supportive treament necessary. (20)
CL Item
Moribund; fatal processes progressing rapidly. (10)
CL Item
Dead. (0)
Item
Lansky
integer
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
CL.47
Code List
Lansky
CL Item
100%: Fully active (100)
CL Item
90%: Minor restriction in physically strenuous play (90)
CL Item
80%: Restricted in strenuous play, tires more easily, otherwise active (80)
CL Item
70%: Both greater restriction of, and less time spent in active play (70)
CL Item
60%: Ambulatory up to 50% of time, limited active play with assistance/supervision (60)
CL Item
50%: Considerable assistance required for any active play; fully able to engage in quiet play (50)
CL Item
40%: Able to initiate quiet activities (40)
CL Item
30%: Needs considerable assistance for quiet activities (30)
CL Item
20%: Limited to very passive activity initiated by others (20)
CL Item
10%: Completely disabled, not even passive play (10)
Fully recovered from prior treatment
Item
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
boolean
C25190 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus Property)
C49498 (NCI Thesaurus Property-2)
C15697 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C2826210 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Item
Prior therapy type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.49
Code List
Prior therapy type
CL Item
Chemotherapy Myelosuppressive Therapy (Myelosuppressive Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
C15690 (NCI Thesaurus-3)
C1513793 (UMLS 2011AA-4)
CL Item
Hematopoietic Growth Factor (Hematopoietic Growth Factor)
C20427 (NCI Thesaurus)
C0021757 (UMLS 2011AA)
CL Item
Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)
CL Item
Autologous Stem Cell Rescue Stem Cell Transplantation (Stem Cell Transplant or Rescue without TBI)
C15431 (NCI Thesaurus)
C0472699 (UMLS 2011AA)
C82054 (NCI Thesaurus-3)
C2825926 (UMLS 2011AA-4)
CL Item
Prior Therapy (nos) (Prior therapy NOS)
CL Item
No Previous Exposure To Drug (nos) (No prior therapy)
Prior Treatment Nitrosourea
Item
Did patient receive nitrosourea
boolean
C25190 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus Property)
C15697 (NCI Thesaurus Property-2)
C699 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1514463 (UMLS CUI [1,1])
C0028210 (UMLS CUI [1,2])
LastTreatmentDate
Item
Last Treatment Date (prior to enrolling on this study)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
PersonPriorClinicalStudyAgentClinicalTrialEligibilityCriteriaInd-2
Item
Has patient previously received any of the indicated agents (To be eligible, patients must not have received prior therapy with PF-02341066.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Stratification
Item
AALL08B1 Stratum
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16153 (NCI Thesaurus Property)
C1514984 (UMLS 2011AA Property)
CL.52
Code List
AALL08B1 Stratum
CL Item
All Patients (All Patients)
Item Group
Consent For Research Studies
PatientCorrelativeStudySpecimenConsentInd-3
Item
Did patient or parent agree to allow the indicated specimen(s) to be banked for future scientific research related to this protocol (Indicated specimens include bone marrow and peripheral blood Instruction # 1 - research on genetic variation - model consent)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientOptionalConsentInd-2
Item
Has the patient given permission for optional sample banking for future cancer research studies (Instruction # 2 - model consent)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
Item
Did patient/parent/guardian agree to have patients' specimen banked for use in research to learn about, prevent, or treat cancer (Instruction # 3 - model consent)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer (Instruction # 4 - model consent)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
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