ID

7474

Description

SOUTHWEST ONCOLOGY GROUP S0337 Prestudy Form Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FE24D648-5D97-43D5-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FE24D648-5D97-43D5-E034-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 8/11/14 8/11/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Bladder Cancer NCT00445601 Pre-Study - SOUTHWEST ONCOLOGY GROUP S0337 Prestudy Form - 2388922v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0337 Prestudy Form
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution/Affiliate
Description

Institution Name

Data type

text

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

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

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

Disease Description

Performance Status
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Date of Initial Pathologic Diagnosis
Description

CancerInitialDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Date of Most Recent Prior Recurrence
Description

RecurrentDiseasePriorOnsetMostRecentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C14173
UMLS 2011AA ObjectClass
C2945760
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25279
UMLS 2011AA Property-2
C0332162
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Date Current Staging Assessment Completed (Note: if patient has only had initial diagnosis, enter same date for all three dates above)
Description

CurrentStageCompleteAssessmentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25471
UMLS 2011AA ObjectClass
C0521116
NCI Thesaurus ObjectClass-2
C16899
UMLS 2011AA ObjectClass-2
C1300072
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Histologic Grade (Current)
Description

BladderTumorHistologicGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12414
UMLS 2011AA ObjectClass-2
C0005682
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain-2
C18000
UMLS 2011AA ValueDomain-2
C0919553
Clinical T Stage (Highest - at current diagnosis/depth of invasion)
Description

BladderTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus ObjectClass-2
C12414
UMLS 2011AA ObjectClass-2
C0005682
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
Is the patient believed, based upon endoscopic inspection, to have urothelial cancer of the prostate or more distant urethra (or urethra at all in women)
Description

UrethraNeoplasmMalignantNeoplasmEndoscopyPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C3428
UMLS 2011AA ObjectClass-2
C0041971
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C16546
UMLS 2011AA Property-2
C0014245
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of endoscopy
Description

EndoscopyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16546
UMLS 2011AA ObjectClass
C0014245
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Date of negative urine culture (OR negative urinalysis See Section 5.4 for details)
Description

UrineSpecimenNegativeCultureProcedureDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25300
UMLS 2011AA Property
C0430400
NCI Thesaurus Property-2
C38757
UMLS 2011AA Property-2
C1513916
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Laboratory Values
Description

Laboratory Values

Collection Date (MM DD YYYY)
Description

SpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property
C2745955
Peripheral Platelet Count (/mcL)
Description

Platelets

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
WBC (X 10^3/mcL)
Description

Leukocytes (WBC)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Hemoglobin (g/dL)
Description

LaboratoryProcedureHemoglobinResultSpecifiedValue

Data type

float

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
Hematocrit (%)
Description

LaboratoryProcedureHematocritOutcomePercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C64796
UMLS 2011AA Property-2
C0018935
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Total Bilirubin (mg/dL)
Description

TotalBilirubinHepaticLabUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass-2
C305
UMLS 2011AA ObjectClass-2
C0005437
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Total bilirubin ULN (mg/dL)
Description

Bilirubin, Total ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25706
mg/dL
SGOT (U/L)
Description

SGOT (AST)

Data type

float

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

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT (U/L)
Description

HepaticSGPT(ALT)LabUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
SGPT (ALT) ULN (U/L)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Alkaline Phosphatase (U/L)
Description

HepaticAlkalinePhosphataseLabValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Serum Creatinine (mg/dL)
Description

PatientCreatinineSerumValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13325
UMLS 2011AA Property
C0229671
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
mg/dL
Serum Creatinine ULN (mg/dL)
Description

Creatinine, serum ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
mg/dL
Risk Factors
Description

Risk Factors

Smoking Status
Description

Smoking history

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1519384
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C18772
Family history of bladder cancer (select one)
Description

BladderCancerFamilyHistoryType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C12414
UMLS 2011AA ObjectClass
C0005682
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C17726
UMLS 2011AA Property
C0241889
Symptoms leading to current bladder cancer diagnosis (select all that apply)
Description

BladderCancerDiagnosisSymptomType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12414
UMLS 2011AA ObjectClass
C0005682
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

BladderCancerDiagnosisSymptomSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C12414
UMLS 2011AA ObjectClass
C0005682
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Turbt History
Description

Turbt History

Date (*Best estimate if exact date unknown)
Description

Surgery Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1628561
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus Property
C25275
Check box if no prior TURBT
Description

SurgicalProcedureNoPriorTransurethralResectionPerformedText

Data type

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C15705
UMLS 2011AA Property-4
C1519630
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Prior Treatment Related To This Bladder Cancer
Description

Prior Treatment Related To This Bladder Cancer

Prior Intravesical Therapy
Description

PriorTherapyIntravesicalAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C13415
UMLS 2011AA Property
C0442124
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
No. of Courses of Immunotherapy
Description

PriorImmunotherapyTreatmentCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Specify agent
Description

PriorImmunotherapyOtherAgent

Data type

text

No. of Courses of Chemotherapy
Description

PriorChemotherapyIntravesicalTreatmentCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C13415
UMLS 2011AA Property
C0442124
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Date last course stopped
Description

PriorTreatmentRegimenEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Date last course stopped
Description

PriorTreatmentRegimenEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Type of Chemotherapy (select all that apply)
Description

PriorIntravesicalChemotherapyType

Data type

text

Specify Agent
Description

PriorIntravesicalChemotherapyOtherAgent

Data type

text

Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 forms
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0337 Prestudy Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
float
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Disease Description
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.1
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
CancerInitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
RecurrentDiseasePriorOnsetMostRecentDate
Item
Date of Most Recent Prior Recurrence
date
C14173 (NCI Thesaurus ObjectClass)
C2945760 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25279 (NCI Thesaurus Property-2)
C0332162 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
CurrentStageCompleteAssessmentDate
Item
Date Current Staging Assessment Completed (Note: if patient has only had initial diagnosis, enter same date for all three dates above)
date
C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ObjectClass-2)
C1300072 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Histologic Grade (Current)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12414 (NCI Thesaurus ObjectClass-2)
C0005682 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)
CL.2
Code List
Histologic Grade (Current)
CL Item
Well Differentiated (Well differentiated (G1))
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderately Differentiated (Moderately differentiated (G2))
C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)
Item
Clinical T Stage (Highest - at current diagnosis/depth of invasion)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C12414 (NCI Thesaurus ObjectClass-2)
C0005682 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
CL.3
Code List
Clinical T Stage (Highest - at current diagnosis/depth of invasion)
CL Item
Noninvasive Papillary Carcinoma (Ta)
CL Item
Tumor Invades Subepithelial Connective Tissue (T1)
UrethraNeoplasmMalignantNeoplasmEndoscopyPresentInd-2
Item
Is the patient believed, based upon endoscopic inspection, to have urothelial cancer of the prostate or more distant urethra (or urethra at all in women)
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C3428 (NCI Thesaurus ObjectClass-2)
C0041971 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C16546 (NCI Thesaurus Property-2)
C0014245 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
EndoscopyDate
Item
Date of endoscopy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16546 (NCI Thesaurus ObjectClass)
C0014245 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
UrineSpecimenNegativeCultureProcedureDate
Item
Date of negative urine culture (OR negative urinalysis See Section 5.4 for details)
date
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25300 (NCI Thesaurus Property)
C0430400 (UMLS 2011AA Property)
C38757 (NCI Thesaurus Property-2)
C1513916 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Laboratory Values
SpecimenCollectedDate
Item
Collection Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Platelets
Item
Peripheral Platelet Count (/mcL)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Leukocytes (WBC)
Item
WBC (X 10^3/mcL)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (g/dL)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHematocritOutcomePercentageValue
Item
Hematocrit (%)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64796 (NCI Thesaurus Property-2)
C0018935 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
TotalBilirubinHepaticLabUnspecifiedValue
Item
Total Bilirubin (mg/dL)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus ObjectClass-2)
C0005437 (UMLS 2011AA ObjectClass-2)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Bilirubin, Total ULN
Item
Total bilirubin ULN (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
SGOT (AST)
Item
SGOT (U/L)
float
C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HepaticSGPT(ALT)LabUnspecifiedValue
Item
SGPT (U/L)
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HepaticAlkalinePhosphataseLabValue
Item
Alkaline Phosphatase (U/L)
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
PatientCreatinineSerumValue
Item
Serum Creatinine (mg/dL)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
Creatinine, serum ULN
Item
Serum Creatinine ULN (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Item Group
Risk Factors
Item
Smoking Status
text
C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
CL.5
Code List
Smoking Status
CL Item
Currently Smoking (Currently smoking)
CL Item
Smoked In The Past (Smoked in the past)
CL Item
Never Smoked (Never smoked)
Item
Family history of bladder cancer (select one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C17726 (NCI Thesaurus Property)
C0241889 (UMLS 2011AA Property)
CL.6
Code List
Family history of bladder cancer (select one)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes But Other Relative (Yes, but other relative)
CL Item
Yes First Degree Relative (Yes, first degree relative)
Item
Symptoms leading to current bladder cancer diagnosis (select all that apply)
text
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
Symptoms leading to current bladder cancer diagnosis (select all that apply)
CL Item
Gross Hematuria (Gross hematuria)
CL Item
Irritative Voiding Symptoms (Irritative voiding symptoms)
CL Item
Microscopic Hematuria (Microscopic hematuria)
CL Item
Other Specify (Other)
BladderCancerDiagnosisSymptomSpecify
Item
Other, specify
text
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Turbt History
Surgery Date
Item
Date (*Best estimate if exact date unknown)
date
C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
SurgicalProcedureNoPriorTransurethralResectionPerformedText
Item
Check box if no prior TURBT
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C15705 (NCI Thesaurus Property-4)
C1519630 (UMLS 2011AA Property-4)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
Prior Treatment Related To This Bladder Cancer
PriorTherapyIntravesicalAdministeredInd-3
Item
Prior Intravesical Therapy
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C13415 (NCI Thesaurus Property)
C0442124 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PriorImmunotherapyTreatmentCount
Item
No. of Courses of Immunotherapy
float
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PriorImmunotherapyOtherAgent
Item
Specify agent
text
PriorChemotherapyIntravesicalTreatmentCount
Item
No. of Courses of Chemotherapy
float
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C13415 (NCI Thesaurus Property-2)
C0442124 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PriorTreatmentRegimenEndDate
Item
Date last course stopped
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
PriorTreatmentRegimenEndDate
Item
Date last course stopped
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
Item
Type of Chemotherapy (select all that apply)
text
CL.9
Code List
Type of Chemotherapy (select all that apply)
CL Item
Mmc (MMC)
CL Item
Thiotepa (Thiotepa)
C875 (NCI Thesaurus)
C0039871 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PriorIntravesicalChemotherapyOtherAgent
Item
Specify Agent
text
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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