ID

10993

Description

E3F05 Brain On-Study Form NCT00978458 Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C76FF0A-A556-4EDB-E040-BB89AD4325FA

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C76FF0A-A556-4EDB-E040-BB89AD4325FA

Mots-clés

  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 16/06/2015 16/06/2015 -
Téléchargé le

16 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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E3F05 Brain On-Study Form NCT00978458

INSTRUCTIONS: Complete this form according to the on-treatment and follow up schedules. Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Report Period
Description

Clinical Trial Period

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Patient demographics
Description

Patient demographics

Patient Initials (Last, First)
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Description

Study Number Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Institution/Affiliate
Description

Institution Name

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
ECOG Patient ID
Description

Patient ID ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Patient ID
Description

Trial subject ID Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Description

Data amended

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Description

Data amended date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Patient Description Pre-registration Hematology/chemistry
Description

Patient Description Pre-registration Hematology/chemistry

Height (cm)
Description

Patient Height

Type de données

float

Unités de mesure
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Description

Patient Weight

Type de données

float

Unités de mesure
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Peripheral Lymphocyte Count
Description

LaboratoryProcedureLymphocyteOutcomeCount

Type de données

float

Alias
NCI Thesaurus Property
C12535
UMLS 2011AA Property
C0024264
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
LLN
Description

LaboratoryProcedurePerformedLowerLimitofNormalValue

Type de données

float

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Peripheral Granulocytes Count (AGC/ANC/mm^3)
Description

Granulocyte count

Type de données

float

Unités de mesure
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0857490
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
1000/uL
Peripheral Granulocytes Count LLN (AGC/ANC/mm^3)
Description

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Type de données

float

Unités de mesure
  • mm3
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mm3
Peripheral Platelet Count (/mm^3 x1000)
Description

Platelets

Type de données

float

Unités de mesure
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Peripheral platelet count, LLN (/mm^3 x1000)
Description

Platelets LLN

Type de données

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
UMLS CUI-2
C1518030
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
Peripheral Hematocrit Count (%)
Description

LaboratoryProcedureErythrocyteResultCount

Type de données

float

Alias
NCI Thesaurus Property
C12521
UMLS 2011AA Property
C0014792
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Peripheral hematocrit count LLN (%)
Description

LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue

Type de données

text

Unités de mesure
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12521
UMLS 2011AA Property
C0014792
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
%
SGOT (AST) (U/L)
Description

SGOT (AST)

Type de données

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201899
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGOT (AST) ULN (U/L)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Type de données

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Test not done (Mark an "X" below if test not done.)
Description

Laboratory Procedure Not Performed

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date Hematology (Blood) Sample Obtained (M D Y)
Description

HematologySpecimenCollectedDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Date of Definitive Histologic Diagnosis of Primary Tumor (M D Y)
Description

PrimaryTumorDiagnosisDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of Progression (tumor by serial MRI M D Y)
Description

DiseaseProgressionDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Mark an 'X' if N/A
Description

DataUnknownText

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Histologic Type
Description

BrainTumorHistologicCategory

Type de données

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12439
UMLS 2011AA ObjectClass-2
C0006104
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
Prior Brain Surgery
Description

Prior Brain Surgery

Date of prior surgery (M D Y)
Description

PriorSurgeryDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Extent of Resection
Description

BrainMalignantNeoplasmExtentSurgicalResectionType

Type de données

text

Alias
NCI Thesaurus ObjectClass
C12439
UMLS 2011AA ObjectClass
C0006104
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25698
NCI Thesaurus Property-2
C15232
UMLS 2011AA Property
C0728940
NCI Thesaurus Property-3
C25332
UMLS 2011AA Property-2
C0439792
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Motivation For Study Entry
Description

Motivation For Study Entry

Medical History (Has patient been diagnosed with any of the following code response for ALL)
Description

ConcomitantDiseasePersonalMedicalHistoryType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Has the patient progressed radiographically (If yes answer one of the following questions)
Description

DiagnosticImagingRadiologyDiseaseProgressionPresentInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C17059
UMLS 2011AA Property-2
C0034599
NCI Metathesaurus Property
CL101509
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-3
C0012634
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
For newly diagnosed patients, or patients entering at time of progression who have had surgery for this progression, what was the pre-operative maximum tumor diameter by T2/FLAIR (cm)
Description

PreoperativeDiagnosticImagingMaximumMalignantNeoplasmDiameterPresentMeasurement

Type de données

float

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass-2
C54732
UMLS 2011AA ObjectClass-2
C0445204
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C25564
UMLS 2011AA Property-3
C0806909
NCI Metathesaurus Property
C0332517
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
For patients entering with disease progression since primary surgery, and are not having new surgery for this progression, enter maximum tumor diameter at time of progression (cm)
Description

PostoperativeDiseaseProgressionDiagnosticImagingMaximumMalignantNeoplasmDiameterPresentMeasurement

Type de données

float

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass-2
C28006
UMLS 2011AA ObjectClass-2
C0032790
NCI Thesaurus ObjectClass-3
C17747
UMLS 2011AA ObjectClass-3
C0242656
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C25564
UMLS 2011AA Property-3
C0806909
NCI Metathesaurus Property
C0332517
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Is the patient >= 40 years old
Description

PatientAgeInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Is the person receiving anti-convulsant medication?
Description

AnticonvulsantMedicationAdministrationInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass-2
C264
UMLS 2011AA ObjectClass-2
C0003286
Adverse Events Present At Time Of Registration (pre-treatment)
Description

Adverse Events Present At Time Of Registration (pre-treatment)

CTC Adverse Event Term (include subterm if applicable Use Active Version of the NCI CTCAE v4.0)
Description

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Type de données

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
CTC Adverse Event Grade (Use grade 1-4 per CTCAE)
Description

AdverseEventSeverityGrade

Type de données

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date (M D Y)
Description

Investigator Signature Date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089

Similar models

INSTRUCTIONS: Complete this form according to the on-treatment and follow up schedules. Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Code List
Report Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Patient Description Pre-registration Hematology/chemistry
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
LaboratoryProcedureLymphocyteOutcomeCount
Item
Peripheral Lymphocyte Count
float
C12535 (NCI Thesaurus Property)
C0024264 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedurePerformedLowerLimitofNormalValue
Item
LLN
float
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Granulocyte count
Item
Peripheral Granulocytes Count (AGC/ANC/mm^3)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
Item
Peripheral Granulocytes Count LLN (AGC/ANC/mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Peripheral Platelet Count (/mm^3 x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets LLN
Item
Peripheral platelet count, LLN (/mm^3 x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureErythrocyteResultCount
Item
Peripheral Hematocrit Count (%)
float
C12521 (NCI Thesaurus Property)
C0014792 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue
Item
Peripheral hematocrit count LLN (%)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12521 (NCI Thesaurus Property)
C0014792 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
SGOT (AST)
Item
SGOT (AST) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Laboratory Procedure Not Performed
Item
Test not done (Mark an "X" below if test not done.)
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained (M D Y)
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)
PrimaryTumorDiagnosisDate
Item
Date of Definitive Histologic Diagnosis of Primary Tumor (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
DiseaseProgressionDate
Item
Date of Progression (tumor by serial MRI M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DataUnknownText
Item
Mark an 'X' if N/A
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus ObjectClass-2)
C0006104 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
Code List
Histologic Type
CL Item
Astrocytoma (Astrocytoma)
CL Item
9450-3 Oligodendroglioma, Nos (c71._) (Oligodendroglioma)
CL Item
Oligoastrocytoma (Oligoastrocytoma)
Item Group
Prior Brain Surgery
PriorSurgeryDate
Item
Date of prior surgery (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Extent of Resection
text
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property)
C25332 (NCI Thesaurus Property-3)
C0439792 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Extent of Resection
CL Item
Biopsy (Biopsy)
C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
CL Item
Bulk Removal Or 50% To 89% Removal (Bulk removal or 50% to 89% removal)
CL Item
Minimal Excision <50% Total Estimated Volume (Minimal excision <50% total estimated volume)
CL Item
Almost Total Resection >90% Removal (Almost total resection >90% removal)
Item Group
Motivation For Study Entry
Item
Medical History (Has patient been diagnosed with any of the following code response for ALL)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Medical History (Has patient been diagnosed with any of the following code response for ALL)
CL Item
Headaches Associated With Mass Effect (Headaches associated with mass effect)
CL Item
Uncontrolled Seizures Despite 2 Different Antiepileptic Drug Regimens (Uncontrolled seizures despite 2 different antiepileptic drug regimens)
CL Item
Focal Neurological Symptoms (Focal neurological symptoms)
CL Item
Cognitive Symptoms Or Deficits (Cognitive symptoms or deficits)
CL Item
Tumor Progression By Serial Mris, Defined As New Enhancement (Tumor progression by serial MRIs, defined as New enhancement)
CL Item
Tumor Progression By Serial Mris, Defined As New T2 Or Flair Signal Abnormality (Tumor progression by serial MRIs, defined as New T2 or FLAIR signal abnormality)
DiagnosticImagingRadiologyDiseaseProgressionPresentInd-2
Item
Has the patient progressed radiographically (If yes answer one of the following questions)
boolean
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C17059 (NCI Thesaurus Property-2)
C0034599 (UMLS 2011AA Property-2)
CL101509 (NCI Metathesaurus Property)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PreoperativeDiagnosticImagingMaximumMalignantNeoplasmDiameterPresentMeasurement
Item
For newly diagnosed patients, or patients entering at time of progression who have had surgery for this progression, what was the pre-operative maximum tumor diameter by T2/FLAIR (cm)
float
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus ObjectClass-2)
C0445204 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25564 (NCI Thesaurus Property-3)
C0806909 (UMLS 2011AA Property-3)
C0332517 (NCI Metathesaurus Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
PostoperativeDiseaseProgressionDiagnosticImagingMaximumMalignantNeoplasmDiameterPresentMeasurement
Item
For patients entering with disease progression since primary surgery, and are not having new surgery for this progression, enter maximum tumor diameter at time of progression (cm)
float
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass-2)
C0032790 (UMLS 2011AA ObjectClass-2)
C17747 (NCI Thesaurus ObjectClass-3)
C0242656 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25564 (NCI Thesaurus Property-3)
C0806909 (UMLS 2011AA Property-3)
C0332517 (NCI Metathesaurus Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
PatientAgeInd-2
Item
Is the patient >= 40 years old
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)
AnticonvulsantMedicationAdministrationInd-3
Item
Is the person receiving anti-convulsant medication?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C264 (NCI Thesaurus ObjectClass-2)
C0003286 (UMLS 2011AA ObjectClass-2)
Item Group
Adverse Events Present At Time Of Registration (pre-treatment)
Item
CTC Adverse Event Term (include subterm if applicable Use Active Version of the NCI CTCAE v4.0)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Code List
CTC Adverse Event Term (include subterm if applicable Use Active Version of the NCI CTCAE v4.0)
CL Item
Seizure (Seizure)
CL Item
Thromboembolism (Thromboembolic event)
CL Item
Tinnitus (Tinnitus)
Item
CTC Adverse Event Grade (Use grade 1-4 per CTCAE)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
Code List
CTC Adverse Event Grade (Use grade 1-4 per CTCAE)
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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