ID

7878

Descrizione

NCIC-PR.11 Form 1- Initial Evaluation Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF80EFC-B7A8-1C24-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF80EFC-B7A8-1C24-E044-0003BA3F9857

Keywords

versioni (4)
  1. 18/12/14 18/12/14 - Martin Dugas
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 17/09/21 17/09/21 -
Caricato su

9 gennaio 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00499174 On-Study - NCIC-PR.11 Form 1- Initial Evaluation - 2457017v1.0

Inglese

These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

1 moduli  
Patient Information
Descrizione

Patient Information

NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
Descrizione

PatientNationalCancerInstituteofCanadaIdentifierNumber

Tipo di dati

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
C25582
UMLS 2011AA Property-2
C1513884
Patient Initials (first-middle-last)
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Medical Record Number (if permitted by IRB)
Descrizione

Medical Record Number

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Intergroup Patient Serial No
Descrizione

PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C17648
UMLS 2011AA Property-2
C0439064
NCI Thesaurus Property-3
C18205
UMLS 2011AA Property-3
C1521808
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Descrizione

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
NCI Institution Number (CTEP assigned)
Descrizione

NCIInstitutionIdentifierCode

Tipo di dati

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 ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
Investigator First Name
Descrizione

InvestigatorFirstName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Last Name
Descrizione

InvestigatorLastName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property-2
C25551
UMLS 2011AA Property-2
C1517741
Patient's Date of Birth (yyyy - mmm - dd)
Descrizione

Patient Birth Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Investigator Number (NCI Investigator Number)
Descrizione

PhysicianInvestigatorIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C17089
UMLS 2011AA ObjectClass-2
C0035173
Date of Randomization
Descrizione

ProtocolRandomizationDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
Patient Ethnicity (check one only)
Descrizione

PatientEthnicGroupCategory

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16564
UMLS 2011AA Property
C0015031
Payment Method (check one USA only - )
Descrizione

PatientPaymentType

Tipo di dati

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
ZIP Code
Descrizione

AddressPostalCodeIdentifier

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25407
UMLS 2011AA ObjectClass
C1442065
NCI Thesaurus Property
C25621
UMLS 2011AA Property
C1514254
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
NCI Thesaurus ValueDomain-2
C25407
UMLS 2011AA ValueDomain-2
C1442065
NCI Thesaurus ValueDomain-3
C25621
UMLS 2011AA ValueDomain-3
C1514254
Race
Descrizione

Race

Race
Descrizione

PatientRaceCategory

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Physical Exam
Descrizione

Physical Exam

Date of Evaluation (yyyy - mmm - dd)
Descrizione

LesionAssessmentDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Performance Status (check one)
Descrizione

ECOG Performance Status

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Disease History
Descrizione

Disease History

Date of Initial Diagnosis of Primary Tumor (yyyy mmm dd date of initial pathologic diagnosis submit a copy of the pathology report with the Form 1)
Descrizione

FirstBiopsyPositiveDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Histologic Type
Descrizione

ProstateTumorHistologicCategory

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
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
Other specify
Descrizione

Histologic Type, other

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Date Baseline Surgical Gleason Score Obtained (yyyy mmm dd)
Descrizione

SpecimenBaselineGleasonScoreDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property-2
C28084
UMLS 2011AA Property-2
C0332326
Gleason Score Based on Specimen Type
Descrizione

SpecimenGleasonScoreType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus ObjectClass-2
C28084
UMLS 2011AA ObjectClass-2
C0332326
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Gleason Score, Primary Pattern (1-5)
Descrizione

GleasonScorePrimaryPatternValue

Tipo di dati

float

Alias
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25336
UMLS 2011AA Property-2
C0449774
Gleason Score, Secondary Pattern (1-5)
Descrizione

GleasonScoreSecondaryPatternValue

Tipo di dati

float

Alias
NCI Thesaurus Property
C25667
UMLS 2011AA Property
C0175668
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25336
UMLS 2011AA Property-2
C0449774
Gleason Score, Combined (sum of the primary and secondary)
Descrizione

GleasonScoreCombinedPatternValue

Tipo di dati

float

Alias
NCI Thesaurus Property
C25454
UMLS 2011AA Property
C0205195
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25336
UMLS 2011AA Property-2
C0449774
Any tertiary elements of Gleason 4 or 5 pattern?
Descrizione

SpecimenGleasonScoreIndicator

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C28084
UMLS 2011AA Property
C0332326
Percent (%) (If yes,)
Descrizione

SpecimenGleasonScorePercentageValue

Tipo di dati

float

Alias
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C28084
UMLS 2011AA Property
C0332326
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Prostate intraepithelial neoplasia (PIN), High Grade
Descrizione

SpecimenHighGradeProstaticIntraepithelialNeoplasiaInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C5541
UMLS 2011AA Property
C1168327
Atypical small acinar proliferation (ASAP)
Descrizione

ProstatePathologyAtypicalSmallAcinarProliferationDiagnosisInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C18189
UMLS 2011AA ObjectClass-2
C0030664
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C37268
UMLS 2011AA Property-2
C1332353
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total number cores (Left side)
Descrizione

CoreBiopsyProstateGlandNeoplasmPerformedCount

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C12410
UMLS 2011AA Property-2
C0033572
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-3
C0884358
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Total number cores (Left side)
Descrizione

CoreBiopsyProstateGlandNeoplasmPerformedCount

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C12410
UMLS 2011AA Property-2
C0033572
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-3
C0884358
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number cores positive (Left side)
Descrizione

CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus Property
C12410
UMLS 2011AA Property
C0033572
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number cores positive (Left side)
Descrizione

CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus Property
C12410
UMLS 2011AA Property
C0033572
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Specimen/Core No. (CRF text recommended - CRF only shows Specimen/Core #1, 2, 3, 4)
Descrizione

PositiveMalignantNeoplasmProstateSpecimenNumber

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C12410
UMLS 2011AA Property
C0033572
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Percent involved Right side
Descrizione

PositiveMalignantNeoplasmRightProstateSpecimenPercentageValue

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25228
UMLS 2011AA Property
C0205090
NCI Thesaurus Property-2
C12410
UMLS 2011AA Property-2
C0033572
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Percent involved Left side
Descrizione

PositiveMalignantNeoplasmLeftProstateSpecimenPercentageValue

Tipo di dati

float

Unità di misura
  • %
Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25229
UMLS 2011AA Property
C0205091
NCI Thesaurus Property-2
C12410
UMLS 2011AA Property-2
C0033572
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
T Stage, Clinical
Descrizione

ProstateTumorClinicalTStage

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Untitled/disease History (continued)
Descrizione

Untitled/disease History (continued)

Date of Transrectal Ultrasound (yyyy mmm dd)
Descrizione

TransrectalUltrasoundProstateAssessmentDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C18315
UMLS 2011AA ObjectClass
C0373345
NCI Thesaurus Property-2
C12410
UMLS 2011AA Property-2
C0033572
Volume of gland/Prostate gland size (cubic centimetres)
Descrizione

TransrectalUltrasoundProstateAssessmentVolumeMeasurement

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C18315
UMLS 2011AA ObjectClass
C0373345
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C12410
UMLS 2011AA Property-2
C0033572
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25335
UMLS 2011AA ValueDomain-2
C0449468
Hypoechoic area
Descrizione

TransrectalUltrasoundThickMidlineEchoProstateAreaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C18315
UMLS 2011AA ObjectClass
C0373345
NCI Thesaurus Property
C12410
UMLS 2011AA Property
C0033572
NCI Thesaurus Property-2
C25244
UMLS 2011AA Property-2
C0205146
NCI Metathesaurus Property
C0749762
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Size (cm) (If yes,)
Descrizione

TransrectalUltrasoundThickMidlineEchoProstateAreaMeasurement

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C18315
UMLS 2011AA ObjectClass
C0373345
NCI Thesaurus Property
C12410
UMLS 2011AA Property
C0033572
NCI Thesaurus Property-2
C25244
UMLS 2011AA Property-2
C0205146
NCI Metathesaurus Property
C0749762
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25244
UMLS 2011AA ValueDomain-2
C0205146
Date of exam (yyyy mmm dd)
Descrizione

PatientMedicalExaminationDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25305
UMLS 2011AA Property
C0582103
Was the nodule palpable (at baseline)
Descrizione

ProstateMalignantNeoplasmPalpableNoduleInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25606
UMLS 2011AA Property
C0522499
NCI Thesaurus Property-2
C3280
UMLS 2011AA Property-2
C0028259
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Nodule is (If yes, )
Descrizione

ProstateMalignantNeoplasmPalpableNoduleType

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25606
UMLS 2011AA Property
C0522499
NCI Thesaurus Property-2
C3280
UMLS 2011AA Property-2
C0028259
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Maximum Diameter (cm)
Descrizione

TumorMaximumDiameterMeasurement

Tipo di dati

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property-2
C25564
UMLS 2011AA Property-2
C0806909
Date of Baseline PSA (closest to randomization yyyy mmm dd)
Descrizione

BaselinePSADate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C17525
UMLS 2011AA ObjectClass
C0138741
NCI Thesaurus ObjectClass-2
C25213
UMLS 2011AA ObjectClass-2
C1442488
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Baseline PSA Value
Descrizione

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Tipo di dati

float

Unità di misura
  • ng/ml
Alias
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Date of PSA prior to androgen deprivation therapy (if applicable yyyy mmm dd)
Descrizione

LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C15481
UMLS 2011AA Property-4
C0279492
NCI Metathesaurus Property
CL025479
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
PSA Value prior to androgen deprivation therapy (if applicable)
Descrizione

LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue

Tipo di dati

float

Unità di misura
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C15481
UMLS 2011AA Property-4
C0279492
NCI Metathesaurus Property
CL025479
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
PSA Value (total)
Descrizione

PSA

Tipo di dati

float

Unità di misura
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25712
ng/ml
Units (* ng/ml, mg/L)
Descrizione

AssessmentLabUOM

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units (* ng/ml, mg/L)
Descrizione

AssessmentLabUOM

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units (* ng/ml, mg/L)
Descrizione

AssessmentLabUOM

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Date of PSA Assessment (yyyy mmm dd)
Descrizione

PSA date

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Therapy For Lower Urinary Tract Symptoms/prostate Cancer Prevention/prostate Cancer
Descrizione

Therapy For Lower Urinary Tract Symptoms/prostate Cancer Prevention/prostate Cancer

5 alpha-reductase inhibitor
Descrizione

HormoneTherapy5Alpha-ReductaseInhibitorPriorAdministeredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C2319
UMLS 2011AA Property-3
C1318898
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Reason for use
Descrizione

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C2319
UMLS 2011AA Property-2
C1318898
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Agent (If yes,)
Descrizione

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C2319
UMLS 2011AA Property-2
C1318898
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Non-steroidal antiandrogen
Descrizione

NonsteroidalAntiandrogenTherapyPriorAdministeredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Metathesaurus ObjectClass
CL316360
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent (If yes,)
Descrizione

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Metathesaurus Property
CL316360
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Date Agent Started (yyyy mmm dd)
Descrizione

Agent Start Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Date Agent Started (yyyy mmm dd)
Descrizione

Agent Start Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Date Agent Started (yyyy mmm dd)
Descrizione

Agent Start Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Date Agent Started (yyyy mmm dd)
Descrizione

Agent Start Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Date Agent Ended (yyyy mmm dd)
Descrizione

Agent End Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Date Agent Ended (yyyy mmm dd)
Descrizione

Agent End Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Date Agent Ended (yyyy mmm dd)
Descrizione

Agent End Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Date Agent Ended (yyyy mmm dd)
Descrizione

Agent End Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
LHRH analogues
Descrizione

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25590
UMLS 2011AA Property
C1518384
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C2022
UMLS 2011AA Property-3
C1268900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent (If yes,)
Descrizione

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25590
UMLS 2011AA Property
C1518384
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C2022
UMLS 2011AA Property-3
C1268900
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Prior Surgery (for prostate cancer other than biopsy or TURP?)
Descrizione

Prior Surgery

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0744961
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus ObjectClass-2
C25629
Radiation Therapy (for prostate cancer?)
Descrizione

RTTreatmentInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C15368
Complementary and alternative medicines (*e.g. Saw palmetto, Vitamin B/E, Selenium, Lycopene)
Descrizione

TherapyComplementaryandAlternativeMedicineAdministeredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15178
UMLS 2011AA Property
C0002346
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Agent (If yes, )
Descrizione

TherapyComplementaryandAlternativeMedicineAdministeredText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15178
UMLS 2011AA Property
C0002346
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Adverse Event Status
Descrizione

Adverse Event Status

Has the patient experienced any symptoms in the 14 days prior to randomization
Descrizione

AdverseEventSymptomInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
CTC Adverse Event Term
Descrizione

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
Grade (Worst this time period - Consult grade definitions in CTCAE version 4.0 handbook and enter appropriate code below. - If event not present, leave event grade field blank.)
Descrizione

AdverseEventSeverityGrade

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Other Major Medical Problems
Descrizione

Other Major Medical Problems

Have there been any major ongoing medical problems? (If yes, please enter details below:)
Descrizione

PatientMedicalHistoryBaselineProblemInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C18772
UMLS 2011AA ObjectClass-2
C0262926
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C28020
UMLS 2011AA Property-2
C0033213
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Disease/Condition
Descrizione

Disease/ConditionNameType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Metathesaurus ObjectClass
CL308231
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
Correlative Studies
Descrizione

Correlative Studies

Did the patient agree to allow tissue from tumor to be collected for tumor banking?
Descrizione

PatientTissueBankingConsentStatus

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Metathesaurus Property
C0087095
Was tissue collected for tumor banking (If yes,)
Descrizione

TissueSpecimenCollectedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Reason
Descrizione

TissueSampleNotCollectedReasonText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C19697
UMLS 2011AA ObjectClass
C1292533
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25452
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25638
UMLS 2011AA ValueDomain-2
C0392360
Quality Of Life Questionnaire
Descrizione

Quality Of Life Questionnaire

Was QoL Questionnaire completed?
Descrizione

QOLCompleteAssessmentIndicator

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Date Questionnaire Completed (yyyy mmm dd Please submit quality of life questionnaires)
Descrizione

QualityofLifeCompleteAssessmentDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25367
Reason Questionnaire was not Completed (check one)
Descrizione

PatientIncompleteQuestionnaireReason

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Other reason, specify
Descrizione

PatientIncompleteQuestionnaireOtherSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C17649
UMLS 2011AA ValueDomain-2
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Planned Therapeutic Action
Descrizione

Planned Therapeutic Action

Planned Therapeutic Action for this patient (*Radical therapy must begin within 90 days of the date of the randomization)
Descrizione

TreatmentPlannedProcedure

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
Radiation Therapy Type
Descrizione

RadiationTherapyProcedureType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25218
UMLS 2011AA Property
C1948041
Comments
Descrizione

Comments

Comments
Descrizione

Research Comments

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Supporting Documentation
Descrizione

Supporting Documentation

Investigator Signature
Descrizione

Investigator Signature

Person Completing Form, Last Name
Descrizione

Person Completing Form Last Name

Tipo di dati

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
Person Completing Form, First Name
Descrizione

Person Completing Form First Name

Tipo di dati

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
Date Form Originally Completed (yyyy - mmm - dd)
Descrizione

Form Completion Date

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
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Similar models

These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Patient Information
PatientNationalCancerInstituteofCanadaIdentifierNumber
Item
NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
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)
C25582 (NCI Thesaurus Property-2)
C1513884 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials (first-middle-last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Medical Record Number (if permitted by IRB)
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber
Item
Intergroup Patient Serial No
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17648 (NCI Thesaurus Property-2)
C0439064 (UMLS 2011AA Property-2)
C18205 (NCI Thesaurus Property-3)
C1521808 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
NCIInstitutionIdentifierCode
Item
NCI Institution Number (CTEP assigned)
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)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)
InvestigatorFirstName
Item
Investigator First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorLastName
Item
Investigator Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)
Patient Birth Date
Item
Patient's Date of Birth (yyyy - mmm - dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
PhysicianInvestigatorIdentifierNumber
Item
Investigator Number (NCI Investigator Number)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
ProtocolRandomizationDate
Item
Date of Randomization
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
Item
Patient Ethnicity (check one only)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA Property)
CL.1
Code List
Patient Ethnicity (check one only)
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
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (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
Payment Method (check one USA 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
Payment Method (check one USA only - )
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
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
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Sponsored (Veterans Sponsored)
AddressPostalCodeIdentifier
Item
ZIP Code
text
C25407 (NCI Thesaurus ObjectClass)
C1442065 (UMLS 2011AA ObjectClass)
C25621 (NCI Thesaurus Property)
C1514254 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus ValueDomain-2)
C1442065 (UMLS 2011AA ValueDomain-2)
C25621 (NCI Thesaurus ValueDomain-3)
C1514254 (UMLS 2011AA ValueDomain-3)
Item Group
Race
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.3
Code List
Race
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
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 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
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)
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)
Item Group
Physical Exam
LesionAssessmentDate
Item
Date of Evaluation (yyyy - mmm - dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Performance Status (check one)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.4
Code List
Performance Status (check one)
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)
Item Group
Disease History
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor (yyyy mmm dd date of initial pathologic diagnosis submit a copy of the pathology report with the Form 1)
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (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.5
Code List
Histologic Type
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Other Specify (Other)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
SpecimenBaselineGleasonScoreDate
Item
Date Baseline Surgical Gleason Score Obtained (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28084 (NCI Thesaurus Property-2)
C0332326 (UMLS 2011AA Property-2)
Item
Gleason Score Based on Specimen Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28084 (NCI Thesaurus ObjectClass-2)
C0332326 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Gleason Score Based on Specimen Type
CL Item
Fine Needle Aspiration Biopsy (Fine Needle Aspirate)
CL Item
Biopsy (Biopsy)
C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
C15189 (NCI Thesaurus-3)
C0005558 (UMLS 2011AA-4)
CL Item
Surgical Specimen (Surgical specimen)
GleasonScorePrimaryPatternValue
Item
Gleason Score, Primary Pattern (1-5)
float
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)
GleasonScoreSecondaryPatternValue
Item
Gleason Score, Secondary Pattern (1-5)
float
C25667 (NCI Thesaurus Property)
C0175668 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)
GleasonScoreCombinedPatternValue
Item
Gleason Score, Combined (sum of the primary and secondary)
float
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)
Item
Any tertiary elements of Gleason 4 or 5 pattern?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28084 (NCI Thesaurus Property)
C0332326 (UMLS 2011AA Property)
CL.7
Code List
Any tertiary elements of Gleason 4 or 5 pattern?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
SpecimenGleasonScorePercentageValue
Item
Percent (%) (If yes,)
float
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28084 (NCI Thesaurus Property)
C0332326 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
SpecimenHighGradeProstaticIntraepithelialNeoplasiaInd-3
Item
Prostate intraepithelial neoplasia (PIN), High Grade
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C5541 (NCI Thesaurus Property)
C1168327 (UMLS 2011AA Property)
ProstatePathologyAtypicalSmallAcinarProliferationDiagnosisInd-2
Item
Atypical small acinar proliferation (ASAP)
boolean
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C37268 (NCI Thesaurus Property-2)
C1332353 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CoreBiopsyProstateGlandNeoplasmPerformedCount
Item
Total number cores (Left side)
float
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CoreBiopsyProstateGlandNeoplasmPerformedCount
Item
Total number cores (Left side)
float
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount
Item
Number cores positive (Left side)
float
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount
Item
Number cores positive (Left side)
float
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PositiveMalignantNeoplasmProstateSpecimenNumber
Item
Specimen/Core No. (CRF text recommended - CRF only shows Specimen/Core #1, 2, 3, 4)
text
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
PositiveMalignantNeoplasmRightProstateSpecimenPercentageValue
Item
Percent involved Right side
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25228 (NCI Thesaurus Property)
C0205090 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
PositiveMalignantNeoplasmLeftProstateSpecimenPercentageValue
Item
Percent involved Left side
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25229 (NCI Thesaurus Property)
C0205091 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
T Stage, Clinical
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.10
Code List
T Stage, Clinical
CL Item
Tumor Incidental Histologic Finding In 5% Or Less Of Tissue Resected (T1a)
CL Item
Tumor Incidental Histologic Finding In More Than 5% Of Tissue Resected (T1b)
CL Item
Tumor Identified By Needle Biopsy (eg, Because Of Elevated Psa) (T1c)
CL Item
Tumor Involves One Lobe (T2a)
CL Item
Tumor Involves Both Lobes (T2b)
CL Item
Tumor Involves Both Lobes (T2c)
Item Group
Untitled/disease History (continued)
TransrectalUltrasoundProstateAssessmentDate
Item
Date of Transrectal Ultrasound (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
TransrectalUltrasoundProstateAssessmentVolumeMeasurement
Item
Volume of gland/Prostate gland size (cubic centimetres)
float
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25335 (NCI Thesaurus ValueDomain-2)
C0449468 (UMLS 2011AA ValueDomain-2)
TransrectalUltrasoundThickMidlineEchoProstateAreaInd-2
Item
Hypoechoic area
boolean
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property-2)
C0205146 (UMLS 2011AA Property-2)
C0749762 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TransrectalUltrasoundThickMidlineEchoProstateAreaMeasurement
Item
Size (cm) (If yes,)
float
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property-2)
C0205146 (UMLS 2011AA Property-2)
C0749762 (NCI Metathesaurus Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25244 (NCI Thesaurus ValueDomain-2)
C0205146 (UMLS 2011AA ValueDomain-2)
PatientMedicalExaminationDate
Item
Date of exam (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25305 (NCI Thesaurus Property)
C0582103 (UMLS 2011AA Property)
ProstateMalignantNeoplasmPalpableNoduleInd-3
Item
Was the nodule palpable (at baseline)
boolean
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25606 (NCI Thesaurus Property)
C0522499 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
Nodule is (If yes, )
text
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25606 (NCI Thesaurus Property)
C0522499 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.13
Code List
Nodule is (If yes, )
CL Item
Mildly Suspicious For Cancer (Mildly suspicious for prostate cancer)
CL Item
Moderately Suspicious For Cancer (Moderately suspicious for prostate cancer)
CL Item
Highly Suspicious For Cancer (Highly suspicious for prostate cancer)
TumorMaximumDiameterMeasurement
Item
Maximum Diameter (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25564 (NCI Thesaurus Property-2)
C0806909 (UMLS 2011AA Property-2)
BaselinePSADate
Item
Date of Baseline PSA (closest to randomization yyyy mmm dd)
date
C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue
Item
Baseline PSA Value
float
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeDate
Item
Date of PSA prior to androgen deprivation therapy (if applicable yyyy mmm dd)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C15481 (NCI Thesaurus Property-4)
C0279492 (UMLS 2011AA Property-4)
CL025479 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue
Item
PSA Value prior to androgen deprivation therapy (if applicable)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C15481 (NCI Thesaurus Property-4)
C0279492 (UMLS 2011AA Property-4)
CL025479 (NCI Metathesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
PSA
Item
PSA Value (total)
float
C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
Item
Units (* ng/ml, mg/L)
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
CL.16
Code List
Units (* ng/ml, mg/L)
CL Item
Micrograms Per Liter (mcg/L)
CL Item
Nanograms Per Milliliter (ng/mL)
Item
Units (* ng/ml, mg/L)
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
CL.16
Code List
Units (* ng/ml, mg/L)
CL Item
Micrograms Per Liter (mcg/L)
CL Item
Nanograms Per Milliliter (ng/mL)
Item
Units (* ng/ml, mg/L)
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
CL.16
Code List
Units (* ng/ml, mg/L)
CL Item
Micrograms Per Liter (mcg/L)
CL Item
Nanograms Per Milliliter (ng/mL)
PSA date
Item
Date of PSA Assessment (yyyy mmm dd)
date
C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Therapy For Lower Urinary Tract Symptoms/prostate Cancer Prevention/prostate Cancer
HormoneTherapy5Alpha-ReductaseInhibitorPriorAdministeredInd-2
Item
5 alpha-reductase inhibitor
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C2319 (NCI Thesaurus Property-3)
C1318898 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason
Item
Reason for use
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property-2)
C1318898 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText
Item
Agent (If yes,)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property-2)
C1318898 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
NonsteroidalAntiandrogenTherapyPriorAdministeredInd-2
Item
Non-steroidal antiandrogen
boolean
C15368 (NCI Thesaurus ObjectClass)
CL316360 (NCI Metathesaurus ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText
Item
Agent (If yes,)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL316360 (NCI Metathesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Agent Start Date
Item
Date Agent Started (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent Start Date
Item
Date Agent Started (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent Start Date
Item
Date Agent Started (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent Start Date
Item
Date Agent Started (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Date Agent Ended (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Date Agent Ended (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Date Agent Ended (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Date Agent Ended (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2
Item
LHRH analogues
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus Property)
C1518384 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C2022 (NCI Thesaurus Property-3)
C1268900 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText
Item
Agent (If yes,)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus Property)
C1518384 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C2022 (NCI Thesaurus Property-3)
C1268900 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Prior Surgery
Item
Prior Surgery (for prostate cancer other than biopsy or TURP?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
RTTreatmentInd-3
Item
Radiation Therapy (for prostate cancer?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
TherapyComplementaryandAlternativeMedicineAdministeredInd-2
Item
Complementary and alternative medicines (*e.g. Saw palmetto, Vitamin B/E, Selenium, Lycopene)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15178 (NCI Thesaurus Property)
C0002346 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
TherapyComplementaryandAlternativeMedicineAdministeredText
Item
Agent (If yes, )
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15178 (NCI Thesaurus Property)
C0002346 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item Group
Adverse Event Status
AdverseEventSymptomInd-2
Item
Has the patient experienced any symptoms in the 14 days prior to randomization
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
CL.24
Code List
CTC Adverse Event Term
CL Item
Fatigue (Fatigue)
CL Item
Constipation (Constipation)
CL Item
Urinary Frequency (Urinary frequency)
CL Item
Impotence (Erectile dysfunction)
Item
Grade (Worst this time period - Consult grade definitions in CTCAE version 4.0 handbook and enter appropriate code below. - If event not present, leave event grade field blank.)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.25
Code List
Grade (Worst this time period - Consult grade definitions in CTCAE version 4.0 handbook and enter appropriate code below. - If event not present, leave event grade field blank.)
CL Item
Absent Adverse Event (0)
C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item Group
Other Major Medical Problems
PatientMedicalHistoryBaselineProblemInd-2
Item
Have there been any major ongoing medical problems? (If yes, please enter details below:)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Disease/ConditionNameType
Item
Disease/Condition
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL308231 (NCI Metathesaurus ObjectClass)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
Item Group
Correlative Studies
PatientTissueBankingConsentStatus
Item
Did the patient agree to allow tissue from tumor to be collected for tumor banking?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C0087095 (NCI Metathesaurus Property)
TissueSpecimenCollectedInd-2
Item
Was tissue collected for tumor banking (If yes,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
TissueSampleNotCollectedReasonText
Item
Reason
text
C19697 (NCI Thesaurus ObjectClass)
C1292533 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25452 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
C0392360 (UMLS 2011AA ValueDomain-2)
Item Group
Quality Of Life Questionnaire
Item
Was QoL Questionnaire completed?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
CL.29
Code List
Was QoL Questionnaire completed?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed (yyyy mmm dd Please submit quality of life questionnaires)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
Item
Reason Questionnaire was not Completed (check one)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
CL.30
Code List
Reason Questionnaire was not Completed (check one)
CL Item
Questionnaire Not Completed Due To Institutional Error (Questionnaire not completed due to institutional error)
CL Item
Other Reason (Other reason)
PatientIncompleteQuestionnaireOtherSpecify
Item
Other reason, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
Item Group
Planned Therapeutic Action
Item
Planned Therapeutic Action for this patient (*Radical therapy must begin within 90 days of the date of the randomization)
text
C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
CL.31
Code List
Planned Therapeutic Action for this patient (*Radical therapy must begin within 90 days of the date of the randomization)
CL Item
Radical Prostatectomy (Radical prostatectomy)
C15399 (NCI Thesaurus)
C0194810 (UMLS 2011AA)
CL Item
Radical Radiation Therapy (Radical radiation therapy)
Item
Radiation Therapy Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)
CL.32
Code List
Radiation Therapy Type
CL Item
External Beam Radiation Therapy (External beam)
C15751 (NCI Thesaurus)
C1517033 (UMLS 2011AA)
CL Item
Prostate Implant Brachytherapy (Permanent prostate brachytherapy)
CL044586 (NCI Metathesaurus)
CL Item
High-dose Rate Brachytherapy (High dose rate temporary brachytherapy)
C15651 (NCI Thesaurus)
C0454270 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Supporting Documentation
Item Group
Investigator Signature
Person Completing Form Last Name
Item
Person Completing Form, 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
Person Completing Form, 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)
Form Completion Date
Item
Date Form Originally Completed (yyyy - mmm - dd)
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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