ID

8908

Beskrivning

GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1F54BBE-5B83-73AD-E040-BB89AD4338D5

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1F54BBE-5B83-73AD-E040-BB89AD4338D5

Nyckelord

Versioner (2)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Sarcoma Pre-Study - GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus) - 3307969v1.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus)
    1. No Instruction available.
Tracking Information
Beskrivning

Tracking Information

GOG Institution Code
Beskrivning

InstitutionGynecologicOncologyGroupIdentifierCode

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
GOG Affiliate Code
Beskrivning

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass-2
C25413
UMLS 2011AA ObjectClass-2
C1510826
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Previous GOG #
Beskrivning

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Treating physician
Beskrivning

TreatingPhysicianName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Other Physician
Beskrivning

PhysicianPersonVerificationIdentifierName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25741
UMLS 2011AA ObjectClass-2
C0031831
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C45513
UMLS 2011AA Property-2
C1711411
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Patient Hospital No.
Beskrivning

Medical Record Number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Date of Birth
Beskrivning

PersonBirthDate

Datatyp

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
Patient Last Name
Beskrivning

Last Name

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301584
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
Patient First Name
Beskrivning

First Name

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1443235
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
Patient Middle Name
Beskrivning

PatientMiddleName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Eligibility
Beskrivning

Eligibility

Did the patient sign an approved informed consent
Beskrivning

InformedConsentFormSignedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Has HIPAA authorization been obtained?
Beskrivning

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
Does the patient have the ability to understand the written informed consent?
Beskrivning

PatientConsentAbilityInd-2

Datatyp

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
Is the patient eligible for a higher priority GOG protocol
Beskrivning

PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25521
UMLS 2011AA Property
C1512288
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C48911
UMLS 2011AA Property-3
C0549179
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
What is the primary disease site
Beskrivning

GynecologicMalignantNeoplasmPrimarySite

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
What is the cell type
Beskrivning

GynecologicTumorHistologicCategory

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
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
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Date the disease was documented histologically
Beskrivning

MalignantNeoplasmInitialHistologicDiagnosisDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C25526
UMLS 2011AA Property-2
C0205462
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
Is the disease incurable recurrent or persistent? Which one?
Beskrivning

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaStatus

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17747
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Date recurrence or persistence documented?
Beskrivning

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17747
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C15220
UMLS 2011AA Property-4
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?
Beskrivning

PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C8507
UMLS 2011AA Property-3
C1513041
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?
Beskrivning

PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C8507
UMLS 2011AA Property-3
C1513041
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus Property-5
C25681
UMLS 2011AA Property-5
C0456389
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
Beskrivning

PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C8507
UMLS 2011AA Property-2
C1513041
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C49164
UMLS 2011AA Property-4
C1709926
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Is the measurable disease in a previously irradiated field?
Beskrivning

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C8507
UMLS 2011AA Property-2
C1513041
NCI Thesaurus Property-3
C54648
UMLS 2011AA Property-3
C1882536
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
Beskrivning

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaInd-3b

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C8507
UMLS 2011AA Property-2
C1513041
NCI Thesaurus Property-3
C54648
UMLS 2011AA Property-3
C1882536
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy
Beskrivning

PatientRecoveryEligibilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
Beskrivning

PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C26726
UMLS 2011AA Property-2
C0009450
NCI Thesaurus Property-3
C258
UMLS 2011AA Property-3
C0003232
NCI Thesaurus Property-4
C25652
UMLS 2011AA Property-4
C1514873
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
Beskrivning

PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C15445
UMLS 2011AA Property-2
C0279025
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
Beskrivning

PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C25484
UMLS 2011AA Property-4
C1444662
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had one prior chemotherapeutic regimen for management of leiomyosarcoma?
Beskrivning

PersonPriorChemotherapyClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Drug Regimen 1:
Beskrivning

ChemotherapyRegimenOneReceiveName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C66832
UMLS 2011AA Property-2
C0205447
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Start date for Regimen 1:
Beskrivning

ChemotherapyRegimenOneReceiveBeginDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C66832
UMLS 2011AA Property-2
C0205447
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date for Regimen 1:
Beskrivning

ChemotherapyRegimenOneReceiveEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C66832
UMLS 2011AA Property-2
C0205447
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
How many additional cytotoxic chemotherapy regimens has the patient received
Beskrivning

ChemotherapyRegimenReceiveChemotherapyRegimenReceiveType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
Drug Regimen 2:
Beskrivning

ChemotherapyRegimenTwoReceiveName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Start date for Regimen 2:
Beskrivning

ChemotherapyRegimenTwoReceiveBeginDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date for Regimen 2:
Beskrivning

ChemotherapyRegimenTwoReceiveEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
Performance Status
Beskrivning

ECOG Performance Status

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Has the patient received prior therapy directed at Aurora kinase for management of recurrent or persistent disease?
Beskrivning

PersonRecurrentDiseaseDiseaseProgressionTherapeuticProcedureClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C17747
UMLS 2011AA Property-2
C0242656
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of Results
Beskrivning

LaboratoryProcedureEvaluationOutcomeDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Leukocytes greater than or equal to 3000/mcL?
Beskrivning

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2

Datatyp

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
ANC greater than or equal to 1,500/mcl?
Beskrivning

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Datatyp

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
Platelets greater than or equal to 100,000/mcl?
Beskrivning

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Datatyp

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
Is Bilirubin less than or equal to ULN?
Beskrivning

LaboratoryProcedureTotalBilirubinResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
Serum creatinine less than or equal to Institutional ULN OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 (calculated or measured)
Beskrivning

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Is the AST and ALT less than or equal to 3.0 X ULN
Beskrivning

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25293
UMLS 2011AA Property-3
C0376147
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the alkaline phosphatase less than or equal to 2.5 x ULN?
Beskrivning

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Has the patient met the pre-entry requirements as specified in section 7.0
Beskrivning

PatientEligibilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
If patient is of childbearing potential, has she had a negative serum pregnancy test within 14 days prior to study entry and agreed to practice an effective means of contraception during study treatment?
Beskrivning

PatientNegativePregnancyTestInd-4

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Is the patient age 18 years or older
Beskrivning

PatientAgeInd-2

Datatyp

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 patient able to take oral medication and maintain a fast for 2 hours before and 1 hour after MLN8237 administration?
Beskrivning

PatientOralMedicationAdministrationFastingAbilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C459
UMLS 2011AA Property
C0013227
NCI Thesaurus Property-2
C25311
UMLS 2011AA Property-2
C0442027
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus Property-4
C78209
UMLS 2011AA Property-4
C0085732
NCI Thesaurus Property-5
C63663
UMLS 2011AA Property-5
C0015663
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Will the patient take agents that effect gastric pH within 4 days (any proton pump inhibitor) or 1 day (any histamine-2 antagonist) of planned start of therapy?
Beskrivning

Anti-ulcerAgentPriorPlanTherapeuticProcedureAdministeredInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C29701
UMLS 2011AA ObjectClass
C0003216
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25619
UMLS 2011AA Property-2
C1301732
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient able to avoid all other types of antacids for 2 hours before and 2 hours after each dose of MLN8237?
Beskrivning

Anti-ulcerAgentNegationPriorPlanTherapeuticProcedureUseInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C29701
UMLS 2011AA ObjectClass
C0003216
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25619
UMLS 2011AA Property-3
C1301732
NCI Thesaurus Property-4
C49236
UMLS 2011AA Property-4
C0087111
NCI Thesaurus Property-5
C25340
UMLS 2011AA Property-5
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had prior therapy with MLN8237 or taken part in a study of an investigational compound or device within 4 weeks of entering this study?
Beskrivning

PriorInvestigationalTherapiesAdministeredInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Metathesaurus ObjectClass
C0949266
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Has the patient had surgery (excluding biopsy), radiotherapy, or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the planned start of protocol treatment?
Beskrivning

PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C15632
UMLS 2011AA Property-2
C0392920
NCI Thesaurus Property-3
C15262
UMLS 2011AA Property-3
C0021083
NCI Thesaurus Property-4
C15329
UMLS 2011AA Property-4
C0543467
NCI Thesaurus Property-5
C25629
UMLS 2011AA Property-5
C0332152
NCI Thesaurus Property-6
C25370
UMLS 2011AA Property-6
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient currently recovering from adverse events due to agents administered more than 4 weeks earlier?
Beskrivning

PersonPriorTherapyAdverseEventClinicalTrialEligibilityCriteriaEligibilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property-2
C16124
UMLS 2011AA Property-2
C1514463
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had hormonal agents within 1 week of the planned start of protocol treatment?
Beskrivning

RecentEndocrineTherapyReceiveInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass-2
C25280
UMLS 2011AA ObjectClass-2
C0332185
Has the patient had another invasive malignancy other than non-melanoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast present or recur within the past 3 years?
Beskrivning

PatientNeoplasmPersonalMedicalHistoryIndicator

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
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
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of uterine leiomyosarcoma within the last 3 years? (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
Beskrivning

PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property-2
C12664
UMLS 2011AA Property-2
C0230168
NCI Thesaurus Property-3
C12767
UMLS 2011AA Property-3
C0030797
NCI Thesaurus Property-4
C25629
UMLS 2011AA Property-4
C0332152
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of uterine leiomyosarcoma within the last three years? (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
Beskrivning

PriorGynecologicChemotherapyAdministeredInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C28016
UMLS 2011AA ObjectClass-3
C0205480
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is patient nursing
Beskrivning

NursingMotherInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25189
UMLS 2011AA Property
C0026591
NCI Thesaurus ObjectClass
C16926
UMLS 2011AA ObjectClass
C0028677
Does the patient have a known history of Central Nervous System metastases and/or carcinomatous meningitis?
Beskrivning

MeningealNeoplasmMetastaticMalignantNeoplasmtotheBrainPresentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3813
UMLS 2011AA ObjectClass
C0220650
NCI Thesaurus ObjectClass-2
C3229
UMLS 2011AA ObjectClass-2
C0025284
Does the patient have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines?
Beskrivning

ProtocolAgentPriorHypersensitivityInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
Has the patient had a prior allogeneic bone marrow or organ transplant?
Beskrivning

AllogeneicTransplantPriorAdministeredInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Does the patient have a known history of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness, such as sever chronic obstructive pulmonary disease; requirement for supplemental oxygen; or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237?
Beskrivning

PersonSleepDisorderClinicalTrialEligibilityCriteriaEligibilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C3376
UMLS 2011AA Property-2
C0037317
Does the patient require constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes? (Intermittent uses of antacids or H2 antagonists are allowed.)
Beskrivning

ProtonPumpInhibitorTherapyIndicator

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C29723
UMLS 2011AA ObjectClass
C0358591
Does the patient have an inability to swallow oral medication or maintain a fast?
Beskrivning

PatientSwallowingAssessmentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C38028
UMLS 2011AA Property-2
C0011167
Does the patient have any condition that would modify small bowel absorption of oral medications, including malabsorption or resection of pancreas or upper bowel?
Beskrivning

PersonGastrointestinalAbsorptionInhibitionExclusionCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property-2
C41491
UMLS 2011AA Property-2
C1517457
Will the patient receive treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 or during the study?
Beskrivning

AnticonvulsantMedicationReceivedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Did the patient experience a myocardial infarction within the past 6 months, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Beskrivning

CardiovascularDiseasePresentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Is the patient HIV positive?
Beskrivning

HumanImmunodeficiencyVirusDiagnosisInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Is the patient unable to comply with restricting alcohol consumption to no more than 1 standard unit of alcohol [12 oz beer (350 mL), 1.5 oz (45 mL) of 80-proof alcohol, or one 6 oz (175 mL) glass of wine] per day during the study and for 30 days from the last dose of MLN8237?
Beskrivning

AlcoholConsumptionRestrictionClinicalTrialEligibilityCriteriaEligibilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ObjectClass
C16273
UMLS 2011AA ObjectClass
C0001948
NCI Thesaurus Property-2
C53452
UMLS 2011AA Property-2
C0443288
Anticipated date treatment will start
Beskrivning

TreatmentPlannedDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Comments
Beskrivning

Comments

Provide comments about this Fast Fact Sheet
Beskrivning

ClinicalTrialEligibilityCriteriaWorksheetCommentText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
NCI Thesaurus ObjectClass
C16112
UMLS 2011AA ObjectClass
C1516637
NCI Thesaurus Property-2
C73541
UMLS 2011AA Property-2
C2349155
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  1. StudyEvent: GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Tracking Information
InstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Institution Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Affiliate Code
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass-2)
C1510826 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber
Item
Previous GOG #
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
PhysicianPersonVerificationIdentifierName
Item
Other Physician
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass-2)
C0031831 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property-2)
C1711411 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
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)
Last Name
Item
Patient Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
First Name
Item
Patient First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleName
Item
Patient Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Item Group
Eligibility
InformedConsentFormSignedInd-2
Item
Did the patient sign an approved informed consent
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Has HIPAA authorization been obtained?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL.2
Code List
Has HIPAA authorization been obtained?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Exempt - Non-usa Participant (Exempt - non-USA participant)
PatientConsentAbilityInd-2
Item
Does the patient have the ability to understand the written informed 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)
PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2
Item
Is the patient eligible for a higher priority GOG protocol
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C48911 (NCI Thesaurus Property-3)
C0549179 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
What is the primary disease site
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.5
Code List
What is the primary disease site
CL Item
Uterus (Uterus)
C12405 (NCI Thesaurus)
C0042149 (UMLS 2011AA)
Item
What is the cell type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (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)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.6
Code List
What is the cell type
CL Item
Uterine Leiomyosarcoma (Uterine leiomyosarcoma)
MalignantNeoplasmInitialHistologicDiagnosisDate
Item
Date the disease was documented histologically
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
Item
Is the disease incurable recurrent or persistent? Which one?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.7
Code List
Is the disease incurable recurrent or persistent? Which one?
CL Item
Recurrent Disease (Recurrent)
C38155 (NCI Thesaurus)
C0277556 (UMLS 2011AA)
CL Item
Persistent Disease (Persistent)
C90169 (NCI Thesaurus)
PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate
Item
Date recurrence or persistence documented?
date
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator
Item
Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator
Item
Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25681 (NCI Thesaurus Property-5)
C0456389 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator
Item
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C49164 (NCI Thesaurus Property-4)
C1709926 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator
Item
Is the measurable disease in a previously irradiated field?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.12
Code List
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PatientRecoveryEligibilityInd-2
Item
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2
Item
Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C258 (NCI Thesaurus Property-3)
C0003232 (UMLS 2011AA Property-3)
C25652 (NCI Thesaurus Property-4)
C1514873 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2
Item
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2
Item
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorChemotherapyClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient had one prior chemotherapeutic regimen for management of leiomyosarcoma?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChemotherapyRegimenOneReceiveName
Item
Drug Regimen 1:
text
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenOneReceiveBeginDate
Item
Start date for Regimen 1:
date
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenOneReceiveEndDate
Item
End date for Regimen 1:
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
Item
How many additional cytotoxic chemotherapy regimens has the patient received
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
CL.18
Code List
How many additional cytotoxic chemotherapy regimens has the patient received
CL Item
No Chemotherapy Regimens (0 Regimens)
CL Item
One Chemotherapy Regimen (1 Regimen)
CL Item
Two Or More Chemotherapy Regimens (2 or more Regimens)
ChemotherapyRegimenTwoReceiveName
Item
Drug Regimen 2:
text
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenTwoReceiveBeginDate
Item
Start date for Regimen 2:
date
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenTwoReceiveEndDate
Item
End date for Regimen 2:
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.19
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)
PersonRecurrentDiseaseDiseaseProgressionTherapeuticProcedureClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient received prior therapy directed at Aurora kinase for management of recurrent or persistent disease?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationOutcomeDate
Item
Date of Results
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2
Item
Leukocytes greater than or equal to 3000/mcL?
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)
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
Item
ANC greater than or equal to 1,500/mcl?
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)
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
Platelets greater than or equal to 100,000/mcl?
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)
LaboratoryProcedureTotalBilirubinResultInd-2
Item
Is Bilirubin less than or equal to ULN?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
Item
Serum creatinine less than or equal to Institutional ULN OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 (calculated or measured)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseEligibilityDeterminationInd-2
Item
Is the AST and ALT less than or equal to 3.0 X ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25293 (NCI Thesaurus Property-3)
C0376147 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2
Item
Is the alkaline phosphatase less than or equal to 2.5 x ULN?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
PatientEligibilityInd-2
Item
Has the patient met the pre-entry requirements as specified in section 7.0
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item
If patient is of childbearing potential, has she had a negative serum pregnancy test within 14 days prior to study entry and agreed to practice an effective means of contraception during study treatment?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.29
Code List
If patient is of childbearing potential, has she had a negative serum pregnancy test within 14 days prior to study entry and agreed to practice an effective means of contraception during study treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PatientAgeInd-2
Item
Is the patient age 18 years or older
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)
PatientOralMedicationAdministrationFastingAbilityInd-2
Item
Is the patient able to take oral medication and maintain a fast for 2 hours before and 1 hour after MLN8237 administration?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus Property)
C0013227 (UMLS 2011AA Property)
C25311 (NCI Thesaurus Property-2)
C0442027 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C78209 (NCI Thesaurus Property-4)
C0085732 (UMLS 2011AA Property-4)
C63663 (NCI Thesaurus Property-5)
C0015663 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Anti-ulcerAgentPriorPlanTherapeuticProcedureAdministeredInd-2
Item
Will the patient take agents that effect gastric pH within 4 days (any proton pump inhibitor) or 1 day (any histamine-2 antagonist) of planned start of therapy?
boolean
C29701 (NCI Thesaurus ObjectClass)
C0003216 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Anti-ulcerAgentNegationPriorPlanTherapeuticProcedureUseInd-2
Item
Is the patient able to avoid all other types of antacids for 2 hours before and 2 hours after each dose of MLN8237?
boolean
C29701 (NCI Thesaurus ObjectClass)
C0003216 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25619 (NCI Thesaurus Property-3)
C1301732 (UMLS 2011AA Property-3)
C49236 (NCI Thesaurus Property-4)
C0087111 (UMLS 2011AA Property-4)
C25340 (NCI Thesaurus Property-5)
C0457083 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorInvestigationalTherapiesAdministeredInd-2
Item
Has the patient had prior therapy with MLN8237 or taken part in a study of an investigational compound or device within 4 weeks of entering this study?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0949266 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2
Item
Has the patient had surgery (excluding biopsy), radiotherapy, or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the planned start of protocol treatment?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15632 (NCI Thesaurus Property-2)
C0392920 (UMLS 2011AA Property-2)
C15262 (NCI Thesaurus Property-3)
C0021083 (UMLS 2011AA Property-3)
C15329 (NCI Thesaurus Property-4)
C0543467 (UMLS 2011AA Property-4)
C25629 (NCI Thesaurus Property-5)
C0332152 (UMLS 2011AA Property-5)
C25370 (NCI Thesaurus Property-6)
C0680251 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorTherapyAdverseEventClinicalTrialEligibilityCriteriaEligibilityInd-2
Item
Is the patient currently recovering from adverse events due to agents administered more than 4 weeks earlier?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C16124 (NCI Thesaurus Property-2)
C1514463 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RecentEndocrineTherapyReceiveInd-2
Item
Has the patient had hormonal agents within 1 week of the planned start of protocol treatment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25280 (NCI Thesaurus ObjectClass-2)
C0332185 (UMLS 2011AA ObjectClass-2)
PatientNeoplasmPersonalMedicalHistoryIndicator
Item
Has the patient had another invasive malignancy other than non-melanoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast present or recur within the past 3 years?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (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)
PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of uterine leiomyosarcoma within the last 3 years? (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property-2)
C0230168 (UMLS 2011AA Property-2)
C12767 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorGynecologicChemotherapyAdministeredInd-2
Item
Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of uterine leiomyosarcoma within the last three years? (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C28016 (NCI Thesaurus ObjectClass-3)
C0205480 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NursingMotherInd-3
Item
Is patient nursing
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25189 (NCI Thesaurus Property)
C0026591 (UMLS 2011AA Property)
C16926 (NCI Thesaurus ObjectClass)
C0028677 (UMLS 2011AA ObjectClass)
MeningealNeoplasmMetastaticMalignantNeoplasmtotheBrainPresentInd-2
Item
Does the patient have a known history of Central Nervous System metastases and/or carcinomatous meningitis?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3813 (NCI Thesaurus ObjectClass)
C0220650 (UMLS 2011AA ObjectClass)
C3229 (NCI Thesaurus ObjectClass-2)
C0025284 (UMLS 2011AA ObjectClass-2)
ProtocolAgentPriorHypersensitivityInd-3
Item
Does the patient have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
AllogeneicTransplantPriorAdministeredInd-3
Item
Has the patient had a prior allogeneic bone marrow or organ transplant?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
PersonSleepDisorderClinicalTrialEligibilityCriteriaEligibilityInd-2
Item
Does the patient have a known history of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness, such as sever chronic obstructive pulmonary disease; requirement for supplemental oxygen; or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C3376 (NCI Thesaurus Property-2)
C0037317 (UMLS 2011AA Property-2)
ProtonPumpInhibitorTherapyIndicator
Item
Does the patient require constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes? (Intermittent uses of antacids or H2 antagonists are allowed.)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C29723 (NCI Thesaurus ObjectClass)
C0358591 (UMLS 2011AA ObjectClass)
PatientSwallowingAssessmentInd-2
Item
Does the patient have an inability to swallow oral medication or maintain a fast?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)
PersonGastrointestinalAbsorptionInhibitionExclusionCriteriaInd-2
Item
Does the patient have any condition that would modify small bowel absorption of oral medications, including malabsorption or resection of pancreas or upper bowel?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C41491 (NCI Thesaurus Property-2)
C1517457 (UMLS 2011AA Property-2)
AnticonvulsantMedicationReceivedInd-2
Item
Will the patient receive treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 or during the study?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CardiovascularDiseasePresentInd-2
Item
Did the patient experience a myocardial infarction within the past 6 months, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
HumanImmunodeficiencyVirusDiagnosisInd-3
Item
Is the patient HIV positive?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
AlcoholConsumptionRestrictionClinicalTrialEligibilityCriteriaEligibilityInd-2
Item
Is the patient unable to comply with restricting alcohol consumption to no more than 1 standard unit of alcohol [12 oz beer (350 mL), 1.5 oz (45 mL) of 80-proof alcohol, or one 6 oz (175 mL) glass of wine] per day during the study and for 30 days from the last dose of MLN8237?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C16273 (NCI Thesaurus ObjectClass)
C0001948 (UMLS 2011AA ObjectClass)
C53452 (NCI Thesaurus Property-2)
C0443288 (UMLS 2011AA Property-2)
TreatmentPlannedDate
Item
Anticipated date treatment will start
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
ClinicalTrialEligibilityCriteriaWorksheetCommentText
Item
Provide comments about this Fast Fact Sheet
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C16112 (NCI Thesaurus ObjectClass)
C1516637 (UMLS 2011AA ObjectClass)
C73541 (NCI Thesaurus Property-2)
C2349155 (UMLS 2011AA Property-2)
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