ID

43223

Description

E2108 Step 1 On-Study Form - ARM S Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2ED499-121B-8389-E040-BB89AD4330F7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2ED499-121B-8389-E040-BB89AD4330F7

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01242800 On-Study - E2108 Step 1 On-Study Form - ARM S - 3130381v1.0

English

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 forms  
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
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
Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Unnamed2
Description

Unnamed2

Patient Initials (Last, First)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol Number
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
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
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
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
Unnamed4
Description

Unnamed4

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Unnamed3
Description

Unnamed3

ECOG Performance Status (Day 1 of this cycle)
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
Height (cm)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months, or 2 age </= 55 years with no spontaneous menses within the past 12 months e.g. spontaneous or secondary to hysterectomy AND with an FSH level in the postmenopausal range according to local institutional/laboratory standards or > 34.4 IU/L if the institutional range is not available, or 3 history of bilateral oophorectomy, or 4 receiving gonadotropin releasing hormone to suppress ovarian function during the entire period of planned hormonal therapy. Premenopausal: Defined as spontaneous menses occurring within 3 months prior to pre-randomization, and no prior history of bilateral oophorectomy. Perimenopausal: Not meeting criteria for premenopausal or postmenopausal)
Description

PatientMenopauseStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Disease Description
Description

Disease Description

Is primary tumor palpable?
Description

Palpable Tumor

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0746412
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass-2
C25606
Her2/neu expression status by immunohistochemistry
Description

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Data type

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C16487
UMLS 2011AA ObjectClass-2
C0010802
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus Property-3
C61381
UMLS 2011AA Property-3
C0312586
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
FISH HER2/neu chromosome 17 Ratio
Description

FISHAssessmentChromosome17ResultHER2NeuNumber

Data type

float

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13212
UMLS 2011AA Property-2
C0008659
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C17756
UMLS 2011AA ValueDomain-2
C0242957
Mark an 'X' if unknown
Description

DataUnknownText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
ER Status
Description

ERLevelTumorStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
PgR Status
Description

PgRStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
Date of biopsy confirming diagnosis of primary tumor
Description

FirstBiopsyPositiveDate

Data type

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
Biopsy type
Description

BiopsyProcedure

Data type

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
Disease Description
Description

Disease Description

Date of Initial Diagnosis of Metastatic Disease (M D Y)
Description

MetastaticDiseaseInitialDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C14174
UMLS 2011AA ObjectClass
C0036525
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Opposite Breast
Description

OppositeBreastInvolvedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass-2
C25602
UMLS 2011AA ObjectClass-2
C1521805
Mark an 'X' if unknown
Description

DataUnknownText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Distant Lymph Nodes
Description

DistantLymphNodeInvolvedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass-2
C25321
UMLS 2011AA ObjectClass-2
C0443203
NCI Thesaurus Property
C25547
Distant Skin/subcutaneous Tissue
Description

DistantTissueSubcutaneousInvolvedSkinInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass-2
C12801
UMLS 2011AA ObjectClass-2
C0040300
NCI Thesaurus Property
C25547
NCI Thesaurus Property-2
C13353
UMLS 2011AA Property
C0443315
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C12470
UMLS 2011AA ValueDomain-2
C1123023
Bone
Description

BoneInvolvedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C25547
Bone Marrow
Description

BoneMarrowInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Lung
Description

LungInvolvedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus Property
C25547
Biopsy type
Description

BiopsyProcedure

Data type

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
Liver
Description

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12392
UMLS 2011AA Property-2
C0023884
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Pleura
Description

PleuraInvolvedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12469
UMLS 2011AA ObjectClass
C0032225
NCI Thesaurus Property
C25547
Brain
Description

BrainInvolvedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12439
UMLS 2011AA ObjectClass
C0006104
NCI Thesaurus Property
C25547
Other CNS
Description

OtherCNSInvolvedSiteInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C12438
UMLS 2011AA ObjectClass-2
C3714787
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25547
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other
Description

MalignantNeoplasmMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
Other specify
Description

TumorExtensionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25270
UMLS 2011AA Property
C0231448
Date of biopsy confirming diagnosis of metastatic disease (If only one site of metastatic disease coded above:)
Description

BiopsyMetastasisConfirmedPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C19151
UMLS 2011AA Property-2
C0027627
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-3
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Iib - Local-regional Recurrence
Description

Iib - Local-regional Recurrence

Axillary Node(s) and/or Soft Tissue
Description

Local-RegionalBreastAxillaryLymphNodeProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C12904
UMLS 2011AA Property
C0729594
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Infraclavicular Node(s)
Description

Local-RegionalBreastInfraclavicularLymphNodeProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C63705
UMLS 2011AA Property
C0229743
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Skin of breast
Description

Local-RegionalBreastIpsilateralSkinProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C12470
UMLS 2011AA Property
C1123023
NCI Thesaurus Property-3
C25308
UMLS 2011AA Property-2
C0441989
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25755
UMLS 2011AA ValueDomain-2
C0871261
Internal mammary node
Description

Local-RegionalBreastInternalMammaryLymphNodeProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C32853
UMLS 2011AA Property
C0229755
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Breast
Description

Local-RegionalBreastIpsilateralProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C25308
UMLS 2011AA Property
C0441989
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Supraclavicular Node(s)
Description

Local-RegionalBreastSupraclavicularLymphNodeProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C12903
UMLS 2011AA Property
C0229730
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Skin of the chest wall
Description

Local-RegionalBreastSkinChestWallProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25331
NCI Thesaurus Property-2
C12470
UMLS 2011AA Property
C1123023
NCI Thesaurus Property-3
C62484
UMLS 2011AA Property-2
C0205076
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25755
UMLS 2011AA ValueDomain-2
C0871261
Status Of Local-regional Disease
Description

Status Of Local-regional Disease

Skin nodules present?
Description

BreastSkinNodulePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property-2
C3373
UMLS 2011AA Property-2
C0037287
Sum of longest diameter of largest five nodules (If yes,)
Description

BreastSkinNodulePresentSumLongestDiameterValue

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C3373
UMLS 2011AA Property-2
C0037287
NCI Thesaurus ValueDomain
C25558
UMLS 2011AA ValueDomain
C1522425
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25483
UMLS 2011AA ValueDomain-3
C0439534
cm
Ulceration present?
Description

BreastUlcerationPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property-2
C25757
UMLS 2011AA Property-2
C0041582
Area of Ulceration (If yes,)
Description

BreastUlcerationPresentLongestDimensionValue

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C25757
UMLS 2011AA Property-2
C0041582
NCI Thesaurus ValueDomain
C25558
UMLS 2011AA ValueDomain
C1522425
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25483
UMLS 2011AA ValueDomain-3
C0439534
cm
Area of Ulceration
Description

BreastUlcerationPresentLongestPerpendicularAxisValue

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C25757
UMLS 2011AA Property-2
C0041582
NCI Thesaurus ValueDomain
C25558
UMLS 2011AA ValueDomain
C1522425
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C54649
UMLS 2011AA ValueDomain-3
C1295725
cm
Tumor Mobility
Description

BreastNeoplasmMobilityPresentType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C25626
UMLS 2011AA Property-2
C0150312
NCI Thesaurus Property-3
C77919
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Is direct invasion of tumor into skin present?
Description

BreastMalignantNeoplasmInvasionSkinPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C12470
UMLS 2011AA Property-2
C1123023
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus Property-4
C75004
UMLS 2011AA Property-4
C2699153
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Longest dimension of skin invasion (If yes,)
Description

BreastMalignantNeoplasmInvasionSkinPresentLongestDimensionValue

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C12470
UMLS 2011AA Property-2
C1123023
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus Property-4
C75004
UMLS 2011AA Property-4
C2699153
NCI Thesaurus ValueDomain
C25558
UMLS 2011AA ValueDomain
C1522425
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25483
UMLS 2011AA ValueDomain-3
C0439534
cm
Asymptomatic tumor in the intact breast present?
Description

BreastAsymptomaticMalignantNeoplasmPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C3833
UMLS 2011AA Property-3
C0231221
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature 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
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Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-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)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
Baseline Step 1 (Baseline step 1)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
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)
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)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (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
Unnamed4
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Unnamed3
Item
ECOG Performance Status (Day 1 of this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
ECOG Performance Status (Day 1 of this cycle)
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)
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months, or 2 age </= 55 years with no spontaneous menses within the past 12 months e.g. spontaneous or secondary to hysterectomy AND with an FSH level in the postmenopausal range according to local institutional/laboratory standards or > 34.4 IU/L if the institutional range is not available, or 3 history of bilateral oophorectomy, or 4 receiving gonadotropin releasing hormone to suppress ovarian function during the entire period of planned hormonal therapy. Premenopausal: Defined as spontaneous menses occurring within 3 months prior to pre-randomization, and no prior history of bilateral oophorectomy. Perimenopausal: Not meeting criteria for premenopausal or postmenopausal)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.3
Code List
Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months, or 2 age </= 55 years with no spontaneous menses within the past 12 months e.g. spontaneous or secondary to hysterectomy AND with an FSH level in the postmenopausal range according to local institutional/laboratory standards or > 34.4 IU/L if the institutional range is not available, or 3 history of bilateral oophorectomy, or 4 receiving gonadotropin releasing hormone to suppress ovarian function during the entire period of planned hormonal therapy. Premenopausal: Defined as spontaneous menses occurring within 3 months prior to pre-randomization, and no prior history of bilateral oophorectomy. Perimenopausal: Not meeting criteria for premenopausal or postmenopausal)
CL Item
Postmenopausal (Postmenopausal)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus-3)
C0232970 (UMLS 2011AA-4)
C15421 (NCI Thesaurus-5)
C0232970 (UMLS 2011AA-6)
CL Item
Premenopausal (Premenopausal)
C15491 (NCI Thesaurus)
C0279752 (UMLS 2011AA)
CL Item
Perimenopausal (Perimenopausal)
C15692 (NCI Thesaurus)
C3839366 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Disease Description
Palpable Tumor
Item
Is primary tumor palpable?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0746412 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C25606 (NCI Thesaurus ObjectClass-2)
Item
Her2/neu expression status by immunohistochemistry
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass-2)
C0010802 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C61381 (NCI Thesaurus Property-3)
C0312586 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.5
Code List
Her2/neu expression status by immunohistochemistry
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
CL Item
Not Done: C49484 (not done)
C49484 (NCI Thesaurus)
C1272696 (UMLS 2011AA)
FISHAssessmentChromosome17ResultHER2NeuNumber
Item
FISH HER2/neu chromosome 17 Ratio
float
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property-2)
C0008659 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)
DataUnknownText
Item
Mark an 'X' if unknown
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
Item
ER Status
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL.6
Code List
ER Status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (NOT DONE)
CL281691 (NCI Metathesaurus)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
PgR Status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
CL.7
Code List
PgR Status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (NOT DONE)
CL281691 (NCI Metathesaurus)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
FirstBiopsyPositiveDate
Item
Date of biopsy confirming diagnosis of primary tumor
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
Biopsy type
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
CL.20
Code List
Biopsy type
CL Item
Incisional (Incisional)
CL Item
Needle Biopsy (Needle biopsy)
C15190 (NCI Thesaurus)
C0936232 (UMLS 2011AA)
MetastaticDiseaseInitialDiagnosisDate
Item
Date of Initial Diagnosis of Metastatic Disease (M D Y)
date
C14174 (NCI Thesaurus ObjectClass)
C0036525 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Opposite Breast
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25602 (NCI Thesaurus ObjectClass-2)
C1521805 (UMLS 2011AA ObjectClass-2)
CL.9
Code List
Opposite Breast
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DataUnknownText
Item
Mark an 'X' if unknown
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
Item
Distant Lymph Nodes
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus ObjectClass-2)
C0443203 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
CL.10
Code List
Distant Lymph Nodes
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Distant Skin/subcutaneous Tissue
text
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus ObjectClass-2)
C0040300 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
C13353 (NCI Thesaurus Property-2)
C0443315 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12470 (NCI Thesaurus ValueDomain-2)
C1123023 (UMLS 2011AA ValueDomain-2)
CL.11
Code List
Distant Skin/subcutaneous Tissue
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)
Item
Bone
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.12
Code List
Bone
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Marrow
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
CL.13
Code List
Bone Marrow
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)
Item
Lung
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.14
Code List
Lung
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Biopsy type
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
CL.20
Code List
Biopsy type
CL Item
Incisional (Incisional)
CL Item
Needle Biopsy (Needle biopsy)
C15190 (NCI Thesaurus)
C0936232 (UMLS 2011AA)
Item
Liver
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.15
Code List
Liver
CL Item
No (NO)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
Item
Pleura
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12469 (NCI Thesaurus ObjectClass)
C0032225 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.16
Code List
Pleura
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Brain
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.17
Code List
Brain
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Other CNS
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus ObjectClass-2)
C3714787 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.18
Code List
Other CNS
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Other
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
CL.19
Code List
Other
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
TumorExtensionSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)
BiopsyMetastasisConfirmedPerformedDate
Item
Date of biopsy confirming diagnosis of metastatic disease (If only one site of metastatic disease coded above:)
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Local-RegionalBreastAxillaryLymphNodeProgressionInd-3
Item
Axillary Node(s) and/or Soft Tissue
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C12904 (NCI Thesaurus Property-2)
C0729594 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Local-RegionalBreastInfraclavicularLymphNodeProgressionInd-3
Item
Infraclavicular Node(s)
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C63705 (NCI Thesaurus Property-2)
C0229743 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Local-RegionalBreastIpsilateralSkinProgressionInd-3
Item
Skin of breast
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property)
C25308 (NCI Thesaurus Property-3)
C0441989 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
Local-RegionalBreastInternalMammaryLymphNodeProgressionInd-3
Item
Internal mammary node
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C32853 (NCI Thesaurus Property-2)
C0229755 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Local-RegionalBreastIpsilateralProgressionInd-3
Item
Breast
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C25308 (NCI Thesaurus Property-2)
C0441989 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Local-RegionalBreastSupraclavicularLymphNodeProgressionInd-3
Item
Supraclavicular Node(s)
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C12903 (NCI Thesaurus Property-2)
C0229730 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Local-RegionalBreastSkinChestWallProgressionInd-3
Item
Skin of the chest wall
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property)
C62484 (NCI Thesaurus Property-3)
C0205076 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
Item Group
Status Of Local-regional Disease
BreastSkinNodulePresentInd-2
Item
Skin nodules present?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C3373 (NCI Thesaurus Property-2)
C0037287 (UMLS 2011AA Property-2)
BreastSkinNodulePresentSumLongestDiameterValue
Item
Sum of longest diameter of largest five nodules (If yes,)
float
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3373 (NCI Thesaurus Property-2)
C0037287 (UMLS 2011AA Property-2)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25483 (NCI Thesaurus ValueDomain-3)
C0439534 (UMLS 2011AA ValueDomain-3)
BreastUlcerationPresentInd-2
Item
Ulceration present?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25757 (NCI Thesaurus Property-2)
C0041582 (UMLS 2011AA Property-2)
BreastUlcerationPresentLongestDimensionValue
Item
Area of Ulceration (If yes,)
float
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25757 (NCI Thesaurus Property-2)
C0041582 (UMLS 2011AA Property-2)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25483 (NCI Thesaurus ValueDomain-3)
C0439534 (UMLS 2011AA ValueDomain-3)
BreastUlcerationPresentLongestPerpendicularAxisValue
Item
Area of Ulceration
float
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25757 (NCI Thesaurus Property-2)
C0041582 (UMLS 2011AA Property-2)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C54649 (NCI Thesaurus ValueDomain-3)
C1295725 (UMLS 2011AA ValueDomain-3)
Item
Tumor Mobility
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25626 (NCI Thesaurus Property-2)
C0150312 (UMLS 2011AA Property-2)
C77919 (NCI Thesaurus Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.30
Code List
Tumor Mobility
CL Item
Attached To Fascia (Attached to fascia)
CL Item
Chest Wall Fixation (Chest wall fixation)
CL Item
Free (Free)
BreastMalignantNeoplasmInvasionSkinPresentInd-2
Item
Is direct invasion of tumor into skin present?
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C75004 (NCI Thesaurus Property-4)
C2699153 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BreastMalignantNeoplasmInvasionSkinPresentLongestDimensionValue
Item
Longest dimension of skin invasion (If yes,)
float
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C75004 (NCI Thesaurus Property-4)
C2699153 (UMLS 2011AA Property-4)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25483 (NCI Thesaurus ValueDomain-3)
C0439534 (UMLS 2011AA ValueDomain-3)
BreastAsymptomaticMalignantNeoplasmPresentInd-2
Item
Asymptomatic tumor in the intact breast present?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C3833 (NCI Thesaurus Property-3)
C0231221 (UMLS 2011AA Property-3)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature 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)
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