ID

43245

Description

N0874 Registration (Step 2) Eligibility Checklist NCT00731731 Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E51877D-925A-72BF-E040-BB89AD436E3B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E51877D-925A-72BF-E040-BB89AD436E3B

Keywords

Versions (6)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 7/3/15 7/3/15 -
  5. 8/5/15 8/5/15 - Martin Dugas
  6. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Registration Glioblastoma Multiforme N0874 NCT00731731

English

Phase I: To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

1 forms  
Header
Description

Header

Registration Date (mm/dd/yyyy)
Description

PatientRegistrationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCCTG Patient ID
Description

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25581
UMLS 2011AA Property-2
C1518419
Participating Group Code (participant sponsor)
Description

ParticipatingGroupIdentifierCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C17005
UMLS 2011AA ObjectClass-2
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution (treating location)
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Physician of Record
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Patient Medical Record Number
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Last name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Fax
Description

ResponsiblePersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
E-mail
Description

ResponsiblePersonE-mailAddressText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Patient Demographics / Pre-treatment Characteristics
Description

Patient Demographics / Pre-treatment Characteristics

Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Gender
Description

Gender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0079399
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
Date of Birth
Description

PersonBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Zip code
Description

PersonAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Country of Residence
Description

PersonAddressCountryName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25464
UMLS 2011AA ValueDomain
C0454664
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Method of Payment (check oneUSA only)
Description

PatientPaymentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Race
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Ethnicity
Description

Ethnic Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Pre-treatment Requirements
Description

Pre-treatment Requirements

Alias
UMLS CUI-1
C1512693
18 Years and older
Description

18 Years and older

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
Age
Description

Age

Data type

integer

Measurement units
  • years
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
years
Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review
Description

AgreementCentralPathologyReviewGlioblastomaGliosarcomaPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C71684
UMLS 2011AA ObjectClass
C2347585
NCI Thesaurus ObjectClass-2
C25369
UMLS 2011AA ObjectClass-2
C0680240
NCI Thesaurus Property
C3058
UMLS 2011AA Property
C0017636
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C3796
UMLS 2011AA Property-3
C0206726
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Bidimensionally measurable or evaluable disease by gadolinium MRI or contrast CT scan
Description

Bidimensionally measurable or evaluable disease by gadolinium MRI or contrast CT scan

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C37894
NCI Thesaurus Property
C25626
NCI Thesaurus Property-2
C25213
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ValueDomain-2
C9305
UMLS CUI [1]
C1513041
Must begin partial brain radiotherapy on the same day that vorinostat and temozolomide begin. NOTE: Radiotherapy guidelines are detailed in Section 7.1.
Description

PatientRadiationTherapyChemotherapyEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Karnofsky performance status of >=60 (Appendix II) or ECOG performance status 0, 1, or 2 (Appendix V). The same scoring system should be used throughout the study
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
Which scoring system will be used throughout the study
Description

PerformanceStatusScoreSystemType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus Property
C25700
UMLS 2011AA Property
C0449913
NCI Thesaurus Property-2
C25338
UMLS 2011AA Property-2
C0449820
Karnofsky Performance Status
Description

Karnofsky Performance Status

Data type

integer

Measurement units
  • %
Alias
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS CUI [1]
C0206065
Performance Status
Description

Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
UMLS CUI [1]
C1520224
The following laboratory values obtained <= 14 days prior to registration
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest laboratory test date (Note: These dates pertain to the following labs only.)
Description

LaboratoryProcedureEvaluationPerformedFirstDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Latest laboratory test date
Description

LaboratoryProcedureEvaluationPerformedMostRecentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
ANC >= 1500/mL
Description

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
ANC
Description

ANC

Data type

float

Measurement units
  • 1000/ul
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0200633
1000/ul
PLT >= 100,000/mL
Description

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C51951
UMLS 2011AA Property
C0032181
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Peripheral Platelet Count
Description

Peripheral Platelet Count

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0005821
1000/uL
WBC >= 3,000/mL
Description

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
WBC
Description

WBC

Data type

float

Measurement units
  • /ul
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0023508
/ul
HgB >=10.0 g/dL (Note: This level may be reached by transfusion)
Description

HematologyHemoglobinAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0019046
g/dL
Total bilirubin <= 2.0 x ULN
Description

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Bilirubin, total
Description

Bilirubin, total

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201913
mg/dL
Total bilirubin ULN
Description

Total bilirubin ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
SGOT (AST) <= 2.0 X ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Data type

boolean

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 Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
AST (SGOT)
Description

AST (SGOT)

Data type

float

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

AST (SGOT) ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
U/L
Creatinine <= 1.5 mg/dL
Description

LaboratoryProcedureCreatinineResultInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Creatinine
Description

Creatinine

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201976
mg/dL
Life expectancy >=12 weeks
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C37987
NCI Thesaurus Property-2
C25171
NCI Thesaurus Property-3
C25359
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1]
C0023671
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
Description

Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25247
NCI Metathesaurus Property
C0032976
UMLS CUI [1]
C0232973
Negative serum pregnancy test date (If a woman of childbearing potential)
Description

PatientNegativePregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Phase II patient only: Willing and able to complete neurocognitive (see Section 4.2).
Description

NeurologicCognitiveAssessmentCompleteInd-3b

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C25262
UMLS 2011AA ObjectClass-2
C0205494
NCI Thesaurus ObjectClass-3
C37926
UMLS 2011AA ObjectClass-3
C1516691
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Metathesaurus ValueDomain
CL355214
Ability to provide informed written consent
Description

PatientConsentAbilityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C78209
UMLS 2011AA Property-2
C0085732
Willingness to return to NCCTG or ABTC enrolling institution for follow-up
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Phase II patients: Willing to provide mandatory tissue samples (slides or blocks) for research purposes (see Sections 6.1130 and 17.0).
Description

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C25340
UMLS 2011AA Property-4
C0457083
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with vorinostat and temozolomide
Description

PatientNoConcurrentMedicationTreatmentEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C459
UMLS 2011AA Property-2
C0013227
NCI Thesaurus Property-3
C15368
NCI Thesaurus Property-4
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any of the following: Pregnant women, Nursing women, Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for 12 weeks after treatment has ended (Note: Vorinostat is an investigational agent whose genotoxic effects on the developing fetus and newborn are unknown.)
Description

PatientPhysicalExaminationPregnancyBreastFeedingContraindicatedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C20989
UMLS 2011AA ObjectClass-2
C0031809
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property-2
C37933
UMLS 2011AA Property-2
C1444657
NCI Thesaurus Property-3
C25596
UMLS 2011AA Property-3
C0006147
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors
Description

PatientPriorMedicationBrainNeoplasmExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C12439
UMLS 2011AA Property-2
C0006104
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C459
UMLS 2011AA Property-4
C0013227
NCI Thesaurus Property-5
C16148
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior cranial RT
Description

PriorCranialRadiationTherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C37936
UMLS 2011AA ObjectClass-3
C0205096
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Gliadel wafers
Description

PriorCarmustineWaferDosageFormAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C349
UMLS 2011AA ObjectClass-2
C0007257
NCI Thesaurus Property
C43003
UMLS 2011AA Property
C0991560
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Known hypersensitivity to any of the components of vorinostat or other agents used in the study
Description

PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C18772
UMLS 2011AA Property-4
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Valproic acid, another histone deacetylase inhibitor, <=2 weeks prior to registration and during treatment.
Description

PatientValproicAcidExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16148
NCI Thesaurus Property-2
C29536
UMLS 2011AA Property
C0042291
Other active malignancy <=3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Uncontrolled infection
Description

PatientInfectionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
Description

PatientImmunocompromisedExclusionCriteriaind-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property-2
C14139
UMLS 2011AA Property-2
C0085393
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and adverse events of the prescribed regimens
Description

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
Description

PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property-2
C25456
UMLS 2011AA Property-2
C0205420
NCI Thesaurus Property-3
C48932
UMLS 2011AA Property-3
C0205318
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
History of myocardial infarction or unstable angina <=6 months prior to registration or congestive heart failure(CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
Description

SymptomaticChronicHeartDiseasePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25269
UMLS 2011AA ObjectClass
C0231220
NCI Metathesaurus ObjectClass
CL299150
Inability to take oral medications
Description

PatientOralMedicationNoAbilityInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C459
UMLS 2011AA Property-2
C0013227
NCI Thesaurus Property-3
C25311
UMLS 2011AA Property-3
C0442027
NCI Thesaurus Property-4
C78209
UMLS 2011AA Property-4
C0085732
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Description

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C28041
UMLS 2011AA Property-3
C1517586
NCI Thesaurus Property-5
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Congenital long QT syndrome
Description

PatientCongenitalAbnormalityLongQTIntervalExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2849
UMLS 2011AA Property
C0000768
NCI Thesaurus Property-2
C25248
UMLS 2011AA Property-2
C0205166
NCI Thesaurus Property-3
C83501
UMLS 2011AA Property-3
C0429028
NCI Thesaurus Property-4
C16148
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prolonged QTc interval (>450 msec)
Description

PatientProlongedQTIntervalExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C71034
UMLS 2011AA Property
C0151878
NCI Thesaurus Property-2
C16148
Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes <=7 days prior to registration: Quinidine, procainamide, disopyramide; Amiodarone, sotalol, ibutilide, dofetilide; Erythromycin, clarithromycin; Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Description

PatientAgentAdverseEventTorsadesDePointesExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C50779
UMLS 2011AA Property-3
C0040479
NCI Thesaurus Property-4
C16148
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Registration Check
Description

Registration Check

Treatment on this protocol must commence at the accruing membership under the supervision of an NCCTG or ABTC member physician
Description

ManagementNorthCentralCancerTreatmentGroupTherapyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass-2
C61372
UMLS 2011AA ObjectClass-2
C1273870
Treatment cannot begin prior to registration and must begin <=15 days after registration
Description

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pretreatment tests/procedures must be completed <= 21 days prior to registration
Description

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C45513
UMLS 2011AA Property-4
C1711411
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest pretreatment test/procedure date
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Latest pretreatment test/procedure date
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Earliest exception test/procedure date (Exceptions to the above dates: Hematology & Chemistry must be completed <= 14 days prior to registration see Section 4.0.)
Description

PatientPriorRegistrationHematologyChemistryEligibilityDeterminationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C16673
UMLS 2011AA Property-3
C0018943
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus Property-5
C16414
UMLS 2011AA Property-5
C0007996
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
latest exception test/procedure date
Description

PatientPriorRegistrationHematologyChemistryEligibilityDeterminationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C16673
UMLS 2011AA Property-3
C0018943
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus Property-5
C16414
UMLS 2011AA Property-5
C0007996
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
All required baseline symptoms must be documented and graded
Description

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25356
UMLS 2011AA Property-3
C1301725
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Study drug availability checked
Description

ClinicalTrialProtocolAgentAvailabilityChecklistInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C41161
UMLS 2011AA Property
C1521826
NCI Thesaurus Property-2
C25429
UMLS 2011AA Property-2
C0470187
NCI Thesaurus Property-3
C49073
UMLS 2011AA Property-3
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Phase II patients: A mandatory translational research component for tissue (slides or blocks) is part of this study; the patient will be automatically registered onto this component (Sections 3.29d and 17.4).
Description

TranslationalResearchTissueSpecimenObtainIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus ObjectClass-3
C15862
UMLS 2011AA ObjectClass-3
C1519620
NCI Thesaurus Property
C52349
UMLS 2011AA Property
C1301820
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Grouping Factor
Description

Grouping Factor

Phase
Description

ClinicalTrialPhaseStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25257
UMLS 2011AA Property
C0205390
Subgroup Code
Description

PatientSubgroupCharacteristicsStratificationDescriptionType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25693
UMLS 2011AA ObjectClass-2
C1515021
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus Property-2
C25689
UMLS 2011AA Property-2
C1514983
NCI Thesaurus Property-3
C25447
UMLS 2011AA Property-3
C1521970
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
Description

At The Time Of Registration/randomization, The Following Will Also Be Recorded:

Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration, the following will be recorded:)
Description

Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration, the following will be recorded:)

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
NCI Thesaurus ObjectClass-2
C12434
NCI Thesaurus ObjectClass-3
C19157
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C1516654
Patient has given NCCTG permission to give tissue sample(s) to outside researchers
Description

PersonSpecimenExternalInvestigatorConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25936
UMLS 2011AA Property-3
C0035173
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Someone may contact me in the future to ask me to allow other uses of my specimens.
Description

Someone may contact me in the future to ask me to allow other uses of my specimens.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C67527
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C16452
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0521104
Patient has given permission to keep tissue sample(s) for use in genetic research
Description

SpecimenRelatedGeneticResearchConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C17938
UMLS 2011AA Property-2
C0314603
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is this an NCCTG institution
Description

NorthCentralCancerTreatmentGroupHealthcareFacilityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C21541
UMLS 2011AA Property
C0018704
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
Patient has agreed to be enrolled on N0392
Description

PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property-2
C37948
UMLS 2011AA Property-2
C1516879
Patient has agreed to be enrolled on 94-72-52
Description

PatientAnaplasticAstrocytomaNorthCentralCancerTreatmentGroupEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property-2
C37948
UMLS 2011AA Property-2
C1516879
NCI Thesaurus Property-3
C9477
UMLS 2011AA Property-3
C0334579
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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Similar models

Phase I: To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PatientRegistrationDate
Item
Registration Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
PatientNorthCentralCancerTreatmentGroupIdentifierNumber
Item
NCCTG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property-2)
C1518419 (UMLS 2011AA Property-2)
ParticipatingGroupIdentifierCode
Item
Participating Group Code (participant sponsor)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Institution Name
Item
Institution (treating location)
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Person Completing Form Last Name
Item
Last name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
ResponsiblePersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ResponsiblePersonE-mailAddressText
Item
E-mail
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
Item Group
Patient Demographics / Pre-treatment Characteristics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
CL.1
Code List
Gender
CL Item
Male (MALE)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (FEMALE)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PersonBirthDate
Item
Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
PersonAddressPostalCode
Item
Zip code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PersonAddressCountryName
Item
Country of Residence
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
Item
Method of Payment (check oneUSA only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL.2
Code List
Method of Payment (check oneUSA only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.3
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not Reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL.4
Code List
Ethnicity
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Pre-treatment Requirements
C1512693 (UMLS CUI-1)
Age
Item
18 Years and older
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
Age
Item
Age
integer
C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
AgreementCentralPathologyReviewGlioblastomaGliosarcomaPerformedInd-2
Item
Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review
boolean
C71684 (NCI Thesaurus ObjectClass)
C2347585 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus ObjectClass-2)
C0680240 (UMLS 2011AA ObjectClass-2)
C3058 (NCI Thesaurus Property)
C0017636 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C3796 (NCI Thesaurus Property-3)
C0206726 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Measurable Disease
Item
Bidimensionally measurable or evaluable disease by gadolinium MRI or contrast CT scan
boolean
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C25626 (NCI Thesaurus Property)
C25213 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C9305 (NCI Thesaurus ValueDomain-2)
C1513041 (UMLS CUI [1])
PatientRadiationTherapyChemotherapyEligibilityDeterminationInd-2
Item
Must begin partial brain radiotherapy on the same day that vorinostat and temozolomide begin. NOTE: Radiotherapy guidelines are detailed in Section 7.1.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
Karnofsky performance status of >=60 (Appendix II) or ECOG performance status 0, 1, or 2 (Appendix V). The same scoring system should be used throughout the study
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Item
Which scoring system will be used throughout the study
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25700 (NCI Thesaurus Property)
C0449913 (UMLS 2011AA Property)
C25338 (NCI Thesaurus Property-2)
C0449820 (UMLS 2011AA Property-2)
CL.10
Code List
Which scoring system will be used throughout the study
CL Item
Karnofsky Performance Status (Karnofsky Performance Status)
C28013 (NCI Thesaurus)
C0206065 (UMLS 2011AA)
C28013 (NCI Thesaurus-3)
C0206065 (UMLS 2011AA-4)
CL Item
Ecog Performance Status (ECOG Performance Status)
Item
Karnofsky Performance Status
integer
C25162 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C0206065 (UMLS CUI [1])
Karnofsky Performance Status
Code List
Karnofsky Performance Status
CL Item
Dead (0)
CL Item
Moribund, Fatal Processes Progressing Rapidly (10)
CL Item
Normal, No Complaints, No Evidence Of Disease (100)
CL Item
Very Sick, Hospitalization Indicated. Death Not Imminent (20)
CL Item
Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)
CL Item
Disabled, Requires Special Care And Assistance (40)
CL Item
Requires Considerable Assistance And Frequent Medical Care (50)
CL Item
Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)
CL Item
Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)
CL Item
Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)
CL Item
Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)
Item
Performance Status
text
C25162 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI [1])
ECOG Performance Status
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
The following laboratory values obtained <= 14 days prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedFirstDate
Item
Earliest laboratory test date (Note: These dates pertain to the following labs only.)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureEvaluationPerformedMostRecentDate
Item
Latest laboratory test date
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
Item
ANC >= 1500/mL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
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])
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
PLT >= 100,000/mL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
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])
LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2
Item
WBC >= 3,000/mL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
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])
HematologyHemoglobinAssessmentInd-2
Item
HgB >=10.0 g/dL (Note: This level may be reached by transfusion)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
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])
LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2
Item
Total bilirubin <= 2.0 x ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Bilirubin, total
Item
Bilirubin, total
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (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)
C25706 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2
Item
SGOT (AST) <= 2.0 X ULN
boolean
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)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AST
Item
AST (SGOT)
float
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
LaboratoryProcedureCreatinineResultInd-2
Item
Creatinine <= 1.5 mg/dL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
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])
Life expectancy
Item
Life expectancy >=12 weeks
boolean
C16960 (NCI Thesaurus ObjectClass)
C37987 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25359 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0023671 (UMLS CUI [1])
Not pregnant
Item
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
boolean
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0232973 (UMLS CUI [1])
PatientNegativePregnancyTestDate
Item
Negative serum pregnancy test date (If a woman of childbearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
NeurologicCognitiveAssessmentCompleteInd-3b
Item
Phase II patient only: Willing and able to complete neurocognitive (see Section 4.2).
boolean
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25262 (NCI Thesaurus ObjectClass-2)
C0205494 (UMLS 2011AA ObjectClass-2)
C37926 (NCI Thesaurus ObjectClass-3)
C1516691 (UMLS 2011AA ObjectClass-3)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
CL355214 (NCI Metathesaurus ValueDomain)
PatientConsentAbilityInd-2
Item
Ability to provide informed written consent
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)
C78209 (NCI Thesaurus Property-2)
C0085732 (UMLS 2011AA Property-2)
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
Item
Willingness to return to NCCTG or ABTC enrolling institution for follow-up
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonSpecimenUseConsentEligibilityDeterminationIndicator
Item
Phase II patients: Willing to provide mandatory tissue samples (slides or blocks) for research purposes (see Sections 6.1130 and 17.0).
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C25340 (NCI Thesaurus Property-4)
C0457083 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PatientNoConcurrentMedicationTreatmentEligibilityDeterminationInd-2
Item
Willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with vorinostat and temozolomide
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C25456 (NCI Thesaurus Property-4)
C0205420 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
PatientPhysicalExaminationPregnancyBreastFeedingContraindicatedInd-2
Item
Any of the following: Pregnant women, Nursing women, Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for 12 weeks after treatment has ended (Note: Vorinostat is an investigational agent whose genotoxic effects on the developing fetus and newborn are unknown.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus ObjectClass-2)
C0031809 (UMLS 2011AA ObjectClass-2)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property-2)
C1444657 (UMLS 2011AA Property-2)
C25596 (NCI Thesaurus Property-3)
C0006147 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorMedicationBrainNeoplasmExclusionCriteriaInd-2
Item
Prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C12439 (NCI Thesaurus Property-2)
C0006104 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C459 (NCI Thesaurus Property-4)
C0013227 (UMLS 2011AA Property-4)
C16148 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorCranialRadiationTherapyAdministeredInd-2
Item
Prior cranial RT
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C37936 (NCI Thesaurus ObjectClass-3)
C0205096 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorCarmustineWaferDosageFormAdministeredInd-2
Item
Prior Gliadel wafers
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C349 (NCI Thesaurus ObjectClass-2)
C0007257 (UMLS 2011AA ObjectClass-2)
C43003 (NCI Thesaurus Property)
C0991560 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2
Item
Known hypersensitivity to any of the components of vorinostat or other agents used in the study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientValproicAcidExclusionCriteriaInd-2
Item
Valproic acid, another histone deacetylase inhibitor, <=2 weeks prior to registration and during treatment.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16148 (NCI Thesaurus Property)
C29536 (NCI Thesaurus Property-2)
C0042291 (UMLS 2011AA Property)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
Other active malignancy <=3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientInfectionInd-2
Item
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)
PatientImmunocompromisedExclusionCriteriaind-2
Item
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C14139 (NCI Thesaurus Property-2)
C0085393 (UMLS 2011AA Property-2)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
Item
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and adverse events of the prescribed regimens
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
Item
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property-2)
C0205420 (UMLS 2011AA Property-2)
C48932 (NCI Thesaurus Property-3)
C0205318 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SymptomaticChronicHeartDiseasePresentInd-2
Item
History of myocardial infarction or unstable angina <=6 months prior to registration or congestive heart failure(CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25269 (NCI Thesaurus ObjectClass)
C0231220 (UMLS 2011AA ObjectClass)
CL299150 (NCI Metathesaurus ObjectClass)
PatientOralMedicationNoAbilityInd-2
Item
Inability to take oral medications
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C25311 (NCI Thesaurus Property-3)
C0442027 (UMLS 2011AA Property-3)
C78209 (NCI Thesaurus Property-4)
C0085732 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
Item
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C1517586 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-5)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCongenitalAbnormalityLongQTIntervalExclusionCriteriaInd-2
Item
Congenital long QT syndrome
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2849 (NCI Thesaurus Property)
C0000768 (UMLS 2011AA Property)
C25248 (NCI Thesaurus Property-2)
C0205166 (UMLS 2011AA Property-2)
C83501 (NCI Thesaurus Property-3)
C0429028 (UMLS 2011AA Property-3)
C16148 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientProlongedQTIntervalExclusionCriteriaInd-2
Item
Prolonged QTc interval (>450 msec)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C71034 (NCI Thesaurus Property)
C0151878 (UMLS 2011AA Property)
C16148 (NCI Thesaurus Property-2)
PatientAgentAdverseEventTorsadesDePointesExclusionCriteriaInd-2
Item
Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes <=7 days prior to registration: Quinidine, procainamide, disopyramide; Amiodarone, sotalol, ibutilide, dofetilide; Erythromycin, clarithromycin; Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C50779 (NCI Thesaurus Property-3)
C0040479 (UMLS 2011AA Property-3)
C16148 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Registration Check
ManagementNorthCentralCancerTreatmentGroupTherapyInd-2
Item
Treatment on this protocol must commence at the accruing membership under the supervision of an NCCTG or ABTC member physician
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass-2)
C1273870 (UMLS 2011AA ObjectClass-2)
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
Item
Treatment cannot begin prior to registration and must begin <=15 days after registration
boolean
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureVerificationInd-2
Item
Pretreatment tests/procedures must be completed <= 21 days prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C45513 (NCI Thesaurus Property-4)
C1711411 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationHematologyChemistryEligibilityDeterminationBeginDate
Item
Earliest exception test/procedure date (Exceptions to the above dates: Hematology & Chemistry must be completed <= 14 days prior to registration see Section 4.0.)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16673 (NCI Thesaurus Property-3)
C0018943 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C16414 (NCI Thesaurus Property-5)
C0007996 (UMLS 2011AA Property-5)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PatientPriorRegistrationHematologyChemistryEligibilityDeterminationEndDate
Item
latest exception test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16673 (NCI Thesaurus Property-3)
C0018943 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C16414 (NCI Thesaurus Property-5)
C0007996 (UMLS 2011AA Property-5)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2
Item
All required baseline symptoms must be documented and graded
boolean
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25356 (NCI Thesaurus Property-3)
C1301725 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialProtocolAgentAvailabilityChecklistInd-2
Item
Study drug availability checked
boolean
C15207 (NCI Thesaurus ObjectClass)
C41161 (NCI Thesaurus Property)
C1521826 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property-2)
C0470187 (UMLS 2011AA Property-2)
C49073 (NCI Thesaurus Property-3)
C1707357 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TranslationalResearchTissueSpecimenObtainIndicator
Item
Phase II patients: A mandatory translational research component for tissue (slides or blocks) is part of this study; the patient will be automatically registered onto this component (Sections 3.29d and 17.4).
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15862 (NCI Thesaurus ObjectClass-3)
C1519620 (UMLS 2011AA ObjectClass-3)
C52349 (NCI Thesaurus Property)
C1301820 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item Group
Grouping Factor
Item
Phase
text
C15207 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25257 (NCI Thesaurus Property)
C0205390 (UMLS 2011AA Property)
CL.51
Code List
Phase
CL Item
Tests The Activity Of An Agent In A Set Of Diseases (II)
Item
Subgroup Code
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25693 (NCI Thesaurus ObjectClass-2)
C1515021 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property-2)
C1514983 (UMLS 2011AA Property-2)
C25447 (NCI Thesaurus Property-3)
C1521970 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.60
Code List
Subgroup Code
CL Item
Sg1 - Phase I (dose Escalation) (SG1 - Phase I (dose escalation))
CL Item
Sg2 - Phase I (mtd) (SG2 - Phase I (MTD))
CL Item
Sg3 - Phase Ii (SG3 - Phase II)
Item Group
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
Item
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer
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)
permission research
Item
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration, the following will be recorded:)
boolean
C12801 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI [1,1])
C1516654 (UMLS CUI [1,2])
PersonSpecimenExternalInvestigatorConsentInd-2
Item
Patient has given NCCTG permission to give tissue sample(s) to outside researchers
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25936 (NCI Thesaurus Property-3)
C0035173 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Permission to contact
Item
Someone may contact me in the future to ask me to allow other uses of my specimens.
boolean
C38148 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C1522577 (UMLS CUI [1,1])
C0521104 (UMLS CUI [1,2])
SpecimenRelatedGeneticResearchConsentInd-2
Item
Patient has given permission to keep tissue sample(s) for use in genetic research
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)
NorthCentralCancerTreatmentGroupHealthcareFacilityInd-2
Item
Is this an NCCTG institution
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus Property)
C0018704 (UMLS 2011AA Property)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2
Item
Patient has agreed to be enrolled on N0392
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property-2)
C1516879 (UMLS 2011AA Property-2)
PatientAnaplasticAstrocytomaNorthCentralCancerTreatmentGroupEnrollmentInd-2
Item
Patient has agreed to be enrolled on 94-72-52
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property-2)
C1516879 (UMLS 2011AA Property-2)
C9477 (NCI Thesaurus Property-3)
C0334579 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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