ID

7305

Description

ANZGOG-0902 Enrollment Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90675395-7527-57AA-E040-BB89AD43454D

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90675395-7527-57AA-E040-BB89AD43454D

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 8/4/15 8/4/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Cervical Cancer NCT01414608 Pre-Study - ANZGOG-0902 Enrollment - 3139029v1.0

No Instruction available.

  1. StudyEvent: ANZGOG-0902 Enrollment
    1. No Instruction available.
Header
Description

Header

Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Date of Birth
Description

PersonBirthDate

Data type

date

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

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution
Description

Institution Name

Data type

text

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

Inclusion Criteria

Stage
Description

GynecologicTumorGroupingFIGO2009CervicalCarcinomaStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property
C25523
UMLS 2011AA Property
C1522242
Age
Description

PatientAgeValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
ECOG 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
Histologic Type
Description

GynecologicTumorHistologicCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Laboratory Eligibility Data
Description

Laboratory Eligibility Data

Date of Assessment
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
WBC
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
ANC
Description

LaboratoryProcedureNeutrophilResultTotalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Platelets
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
Bilirubin
Description

LaboratoryProcedureTotalBilirubinResultValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
SGOT (AST)
Description

SGOT (AST)

Data type

float

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

SGPT (ALT)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGPT (ALT) ULN
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
Serum creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Serum Creatinine ULN
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
Creatinine Clearance
Description

Creatinine Clearance

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0373595
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Consent
Description

Consent

Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Consent for correlative studies and specimen banking signed
Description

PatientCorrelativeStudySpecimenConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C16100
UMLS 2011AA Property-3
C1511524
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Exclusion Criteria
Description

Exclusion Criteria

Prior Pelvic Radiation Therapy
Description

PriorRTPelvicAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25399
UMLS 2011AA Property
C0030797
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Positive para-aortic nodes
Description

ParaaorticRegionLymphNodeInvolvedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass-2
C25316
UMLS 2011AA ObjectClass-2
C0456269
Is patient receiving brachytherapy
Description

BrachytherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prior Chemotherapy
Description

PriorChemotherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Distant metastases present?
Description

DistantMetastasisPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass-2
C19151
UMLS 2011AA ObjectClass-2
C0027627
Crohn's disease
Description

AdditionalPathologicFindingsCrohn'sDiseaseInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25406
UMLS 2011AA ObjectClass
C1524062
NCI Metathesaurus ObjectClass
C1317598
NCI Metathesaurus Property
C0010346
Patients must not have sensory/motor neuropathy >= grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0
Description

CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C54722
UMLS 2011AA Property
C0205251
NCI Thesaurus Property-2
C4731
UMLS 2011AA Property-2
C0031117
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Hysterectomy
Description

HysterectomyPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15256
UMLS 2011AA ObjectClass
C0020699
Does the patient have a history of the presence of other invasive malignancies, other than non-melanoma skin cancer, within the past 5 years?
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Is the patient pregnant or nursing
Description

PatientPregnancyInd-3b

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Is the patient HIV seropositive
Description

HumanImmunodeficiencyVirusDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Stratification Factors
Description

Stratification Factors

Is there lymph node involvement
Description

LymphNodeInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C25547
Lymph Nodes Type
Description

LymphomaLymphNodeAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass-2
C3208
UMLS 2011AA ObjectClass-2
C0024299
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25421
UMLS 2011AA Property-2
C0002808
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Method of Evaluation
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Footer Module
Description

Footer Module

Investigator Name
Description

InvestigatorName

Data type

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
Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Investigator's signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089

Similar models

No Instruction available.

  1. StudyEvent: ANZGOG-0902 Enrollment
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PersonBirthDate
Item
Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
Institution Number
Item
Institution Code
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Item Group
Inclusion Criteria
Item
Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25523 (NCI Thesaurus Property)
C1522242 (UMLS 2011AA Property)
Code List
Stage
CL Item
Stage Ib1 (IB1)
CL Item
Stage Ib2 (IB2)
CL Item
Stage Iia (IIA)
CL Item
Stage Iib (IIB)
CL Item
Stage Iiib (IIIB)
CL Item
Stage Iva (IVA)
PatientAgeValue
Item
Age
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG 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)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
Code List
Histologic Type
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Adenosquamous (Adenosquamous carcinoma)
Item Group
Laboratory Eligibility Data
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Leukocytes (WBC)
Item
WBC
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)
LaboratoryProcedureNeutrophilResultTotalValue
Item
ANC
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C12533 (NCI Thesaurus Property)
C0027950 (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-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Platelets
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SGOT (AST)
Item
SGOT (AST)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
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)
SGPT (ALT)
Item
SGPT (ALT)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN
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)
Creatinine, Serum
Item
Serum creatinine
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, serum ULN
Item
Serum Creatinine ULN
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)
Creatinine Clearance
Item
Creatinine Clearance
float
C20200 (NCI Thesaurus Property)
C0373595 (UMLS CUI-1)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Item Group
Consent
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientCorrelativeStudySpecimenConsentInd-3
Item
Consent for correlative studies and specimen banking signed
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Exclusion Criteria
PriorRTPelvicAdministeredInd-3
Item
Prior Pelvic Radiation Therapy
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25399 (NCI Thesaurus Property)
C0030797 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ParaaorticRegionLymphNodeInvolvedInd-2
Item
Positive para-aortic nodes
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25316 (NCI Thesaurus ObjectClass-2)
C0456269 (UMLS 2011AA ObjectClass-2)
BrachytherapyAdministeredInd-3
Item
Is patient receiving brachytherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorChemotherapyAdministeredInd-3
Item
Prior Chemotherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
DistantMetastasisPresentInd-2
Item
Distant metastases present?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
AdditionalPathologicFindingsCrohn'sDiseaseInd-3
Item
Crohn's disease
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25406 (NCI Thesaurus ObjectClass)
C1524062 (UMLS 2011AA ObjectClass)
C1317598 (NCI Metathesaurus ObjectClass)
C0010346 (NCI Metathesaurus Property)
CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2
Item
Patients must not have sensory/motor neuropathy >= grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C54722 (NCI Thesaurus Property)
C0205251 (UMLS 2011AA Property)
C4731 (NCI Thesaurus Property-2)
C0031117 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
HysterectomyPerformedInd-3
Item
Hysterectomy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
Does the patient have a history of the presence of other invasive malignancies, other than non-melanoma skin cancer, within the past 5 years?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientPregnancyInd-3b
Item
Is the patient pregnant or nursing
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
HumanImmunodeficiencyVirusDiagnosisInd-3
Item
Is the patient HIV seropositive
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Stratification Factors
LymphNodeInvolvementInd-3
Item
Is there lymph node involvement
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Item
Lymph Nodes Type
text
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass-2)
C0024299 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
Code List
Lymph Nodes Type
CL Item
Common Pelvic (common pelvic)
CL Item
External/internal Iliac (external/internal iliac)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Code List
Method of Evaluation
CL Item
Pet/ct Scan (PET/CT scan)
CL Item
Ct/mri Scan (CT/MRI scan)
CL Item
Biopsy (Biopsy)
C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
C15189 (NCI Thesaurus-3)
C0005558 (UMLS 2011AA-4)
CL Item
Surgery (Surgery)
C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)
Item Group
Footer Module
InvestigatorName
Item
Investigator 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)
Investigator Signature Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature
Item
Investigator's signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

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