ID

9146

Beschreibung

ACOSOG-Z1072 Registration Worksheet Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6EC42FC0-2010-95F5-E040-BB89AD432658

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6EC42FC0-2010-95F5-E040-BB89AD432658

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00723294 Registration - ACOSOG-Z1072 Registration Worksheet - 2919301v1.0

Englisch

Instructions: Mark the appropriate line for each Inclusion and Exclusion Criterion below. Each criterion must be answered and all protocol criteria must be met prior to registering the patient into this study. (If any items are marked "N/A" [not applicable], patient is still eligible to be registered into the study.) NOTE: Each criterion must be addressed and documented in the patient's medical record.)

1 Formulare  
Header Module
Beschreibung

Header Module

Protocol Number
Beschreibung

Protocol ID ACOSOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1515944
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C19712
Patient ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Initials (L F M)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Number
Beschreibung

Institution Number

Datentyp

text

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

Institution Name

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Are data amended (if data are amended, please circle in red when using paper form)
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Eligibility Criteria
Beschreibung

Eligibility Criteria

Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy (NOTE: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. NOTE: Results of ER, PR, HER-2/neu and Oncotye DX if needed must be obtained on pre-registration needle core biopsy material. See Testing Guidelines Section 3.1)
Beschreibung

InvasiveBreastCarcinomaHistologicallyConfirmedIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property-2
C0205462
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
Beschreibung

BreastBiopsyIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
Tumor size <= 2.0 cm in greatest diameter (Specifically, the tumor must measure <=2.0 cm in the axis parallel to the treatment probe and <=1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility)
Beschreibung

BreastCarcinomaTwoCentimeterPresentIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C49668
UMLS 2011AA Property-2
C0475210
NCI Thesaurus Property-3
C66833
UMLS 2011AA Property-3
C0205448
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Tumor enhancement on pre-study MRI
Beschreibung

MeasurableDiseaseEnhancingLesionPresentIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C37894
UMLS 2011AA ObjectClass-2
C1513040
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C28746
UMLS 2011AA Property-2
C1333400
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Tumor with < 25% intraductal components in the aggregate
Beschreibung

TumorHistologicVariationIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25713
UMLS 2011AA Property-2
C0205419
No prior or planned neoadjuvant chemotherapy for breast cancer
Beschreibung

PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C9245
UMLS 2011AA Property
C0853879
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential)
Beschreibung

PatientNegativePregnancyTestIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Adequate breast size for safe cryoablation (Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation)
Beschreibung

BreastSizeDocumentedIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
NCI Thesaurus Property-2
C25356
UMLS 2011AA Property-2
C1301725
Instructions
Beschreibung

Instructions

Patient consented to optional blood sample collection
Beschreibung

PatientOptionalConsentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25603
UMLS 2011AA Property
C1518600
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
Patient's Initial Consent given for blood specimen use for research on the patient's cancer?
Beschreibung

BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient's Initial Consent given for blood specimen use for research unrelated to the patient's cancer?
Beschreibung

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?
Beschreibung

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?
Beschreibung

TissueSpecimenResearchConsentUnrelatedInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25328
UMLS 2011AA ValueDomain-2
C0445356
Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research
Beschreibung

Permission to contact Patient

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C1522577
NCI Thesaurus Property
C67527
UMLS CUI-2
C0521104
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C16452
NCI Thesaurus ValueDomain
C38148
Description Of Primary Disease
Beschreibung

Description Of Primary Disease

MedDRA Code (10006285 [Breast cancer, NOS])
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
Primary Site (Tumor Breast)
Beschreibung

MalignantNeoplasmPrimarySiteText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
Histologic Type (check one)
Beschreibung

BreastTumorHistologicCategory

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Other specify
Beschreibung

Histologic Type, other

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Nuclear Grade (check one)
Beschreibung

BreastNeoplasmNuclearGradeCategory

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C13361
UMLS 2011AA Property
C0521447
NCI Thesaurus Property-2
C48309
UMLS 2011AA Property-2
C0441800
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
Biopsy Data
Beschreibung

Biopsy Data

Date of core needle biopsy (mm/dd/yyyy)
Beschreibung

SurgicalProcedureCoreBiopsyPerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C15680
UMLS 2011AA Property
C1318309
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
Needle gauge
Beschreibung

BiopsyNeedleBiopsyGaugePerformedValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C15190
UMLS 2011AA Property-2
C0936232
NCI Thesaurus Property-3
C73120
UMLS 2011AA Property-3
C0456564
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Biopsy clip placed at time of biopsy (check one)
Beschreibung

BiopsyMammotomeClipPlacementPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C47950
UMLS 2011AA Property-2
C1708928
NCI Thesaurus Property-3
C41148
UMLS 2011AA Property-3
C1524072
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Name of biopsy clip
Beschreibung

BiopsyMammotomeClipPlacementPerformedName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C47950
UMLS 2011AA Property-2
C1708928
NCI Thesaurus Property-3
C41148
UMLS 2011AA Property-3
C1524072
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
% Intraductal component (DCIS %)
Beschreibung

InvasiveBreastCarcinomaHistologicallyConfirmedCellPercentageValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property-2
C0205462
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
HER2 results/IHC (check one)
Beschreibung

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Datentyp

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
HER2 results/FISH (check one)
Beschreibung

FISHCytologyResultType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Date (mm/dd/yyyy)
Beschreibung

Laboratory Procedure Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date (mm/dd/yyyy)
Beschreibung

Laboratory Procedure Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Estrogen/progesterone Data
Beschreibung

Estrogen/progesterone Data

ER Status (check one)
Beschreibung

ERLevelTumorStatus

Datentyp

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 (check one)
Beschreibung

PgRStatusType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
Pregnancy test done (check one)
Beschreibung

PregnancyTestPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
Reason pregnancy test not performed (If no check one)
Beschreibung

PregnancyLaboratoryProcedureNotPerformedReason

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Beschreibung

PregnancyLaboratoryProcedureNotPerformedSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Date of Onset of Most Recent Menstrual Period (mm/dd/yyyy)
Beschreibung

LastMenstrualCycleOnsetDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Metathesaurus ObjectClass
C0025329
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Date (mm/dd/yyyy)
Beschreibung

Laboratory Procedure Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date (mm/dd/yyyy)
Beschreibung

Laboratory Procedure Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Not Applicable (Patient is post-menopausal)
Beschreibung

DataUnknownText

Datentyp

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
Ultrasound/mammogram
Beschreibung

Ultrasound/mammogram

Is oncotype analysis planned (check one)
Beschreibung

LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
Is adequate tumor volume present (If yes check one)
Beschreibung

TumorTotalVolumeStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property-2
C25335
UMLS 2011AA Property-2
C0449468
Date of Ultrasound (mm/dd/yyyy)
Beschreibung

DiagnosticImagingUltrasoundImagingPerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C17230
UMLS 2011AA Property-2
C0041618
Dimension 2 (Tumor size width cm)
Beschreibung

TumorSecondDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Dimension 2 (Tumor size width cm)
Beschreibung

TumorSecondDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Dimension 3 (Tumor size depth cm)
Beschreibung

TumorThirdDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25260
UMLS 2011AA Property
C0205437
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Dimension 3 (Tumor size depth cm)
Beschreibung

TumorThirdDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25260
UMLS 2011AA Property
C0205437
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Date of mammogram (mm/dd/yyyy)
Beschreibung

MammogramPerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20178
UMLS 2011AA ObjectClass
C0024671
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Dimension 1 (Tumor size length cm)
Beschreibung

TumorLargestDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Dimension 1 (Tumor size length cm)
Beschreibung

TumorLargestDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Calcifications (check one)
Beschreibung

BreastMalignantNeoplasmMammogramMicrocalcificationStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C20178
UMLS 2011AA Property
C0024671
NCI Thesaurus Property-2
C8433
UMLS 2011AA Property-2
C0520594
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
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Ähnliche Modelle

Instructions: Mark the appropriate line for each Inclusion and Exclusion Criterion below. Each criterion must be answered and all protocol criteria must be met prior to registering the patient into this study. (If any items are marked "N/A" [not applicable], patient is still eligible to be registered into the study.) NOTE: Each criterion must be addressed and documented in the patient's medical record.)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
Protocol ID ACOSOG
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1515944 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19712 (NCI Thesaurus Property-2)
Patient Study ID
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-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 Number
Item
Institution Number
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)
Data amended
Item
Are data amended (if data are amended, please circle in red when using paper form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Eligibility Criteria
Item
Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy (NOTE: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. NOTE: Results of ER, PR, HER-2/neu and Oncotye DX if needed must be obtained on pre-registration needle core biopsy material. See Testing Guidelines Section 3.1)
text
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.2
Code List
Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy (NOTE: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. NOTE: Results of ER, PR, HER-2/neu and Oncotye DX if needed must be obtained on pre-registration needle core biopsy material. See Testing Guidelines Section 3.1)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
CL.3
Code List
No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Tumor size <= 2.0 cm in greatest diameter (Specifically, the tumor must measure <=2.0 cm in the axis parallel to the treatment probe and <=1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility)
text
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C49668 (NCI Thesaurus Property-2)
C0475210 (UMLS 2011AA Property-2)
C66833 (NCI Thesaurus Property-3)
C0205448 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.4
Code List
Tumor size <= 2.0 cm in greatest diameter (Specifically, the tumor must measure <=2.0 cm in the axis parallel to the treatment probe and <=1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Tumor enhancement on pre-study MRI
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C1513040 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C28746 (NCI Thesaurus Property-2)
C1333400 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.5
Code List
Tumor enhancement on pre-study MRI
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Tumor with < 25% intraductal components in the aggregate
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25713 (NCI Thesaurus Property-2)
C0205419 (UMLS 2011AA Property-2)
CL.6
Code List
Tumor with < 25% intraductal components in the aggregate
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No prior or planned neoadjuvant chemotherapy for breast cancer
text
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C9245 (NCI Thesaurus Property)
C0853879 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.7
Code List
No prior or planned neoadjuvant chemotherapy for breast cancer
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.8
Code List
Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential)
CL Item
N/a (N/A)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Adequate breast size for safe cryoablation (Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property-2)
C1301725 (UMLS 2011AA Property-2)
CL.9
Code List
Adequate breast size for safe cryoablation (Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Instructions
PatientOptionalConsentInd-2
Item
Patient consented to optional blood sample collection
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Patient's Initial Consent given for blood specimen use for research on the patient's cancer?
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Patient's Initial Consent given for blood specimen use for research unrelated to the patient's cancer?
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
Permission to contact Patient
Item
Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research
boolean
C16960 (NCI Thesaurus ObjectClass)
C1522577 (UMLS CUI-1)
C67527 (NCI Thesaurus Property)
C0521104 (UMLS CUI-2)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
Item Group
Description Of Primary Disease
MedDRACode
Item
MedDRA Code (10006285 [Breast cancer, NOS])
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
MalignantNeoplasmPrimarySiteText
Item
Primary Site (Tumor Breast)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
Item
Histologic Type (check one)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.16
Code List
Histologic Type (check one)
CL Item
Infiltrating Ductal Carcinoma (Infiltrating ductal)
CL Item
Other Specify (Other)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
Item
Nuclear Grade (check one)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property-2)
C0441800 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.17
Code List
Nuclear Grade (check one)
CL Item
Low (Low)
CL124342 (NCI Metathesaurus)
CL Item
Intermediate (Intermediate)
C0205103 (NCI Metathesaurus)
CL Item
High (High)
C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)
Item Group
Biopsy Data
SurgicalProcedureCoreBiopsyPerformedDate
Item
Date of core needle biopsy (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
BiopsyNeedleBiopsyGaugePerformedValue
Item
Needle gauge
float
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15190 (NCI Thesaurus Property-2)
C0936232 (UMLS 2011AA Property-2)
C73120 (NCI Thesaurus Property-3)
C0456564 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
BiopsyMammotomeClipPlacementPerformedInd-2
Item
Biopsy clip placed at time of biopsy (check one)
boolean
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C47950 (NCI Thesaurus Property-2)
C1708928 (UMLS 2011AA Property-2)
C41148 (NCI Thesaurus Property-3)
C1524072 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BiopsyMammotomeClipPlacementPerformedName
Item
Name of biopsy clip
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C47950 (NCI Thesaurus Property-2)
C1708928 (UMLS 2011AA Property-2)
C41148 (NCI Thesaurus Property-3)
C1524072 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
InvasiveBreastCarcinomaHistologicallyConfirmedCellPercentageValue
Item
% Intraductal component (DCIS %)
float
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
HER2 results/IHC (check one)
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.19
Code List
HER2 results/IHC (check one)
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)
Item
HER2 results/FISH (check one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.20
Code List
HER2 results/FISH (check one)
CL Item
Amplified (Amplified)
CL Item
Not Amplified (Not amplified)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
Laboratory Procedure Date
Item
Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Estrogen/progesterone Data
Item
ER Status (check one)
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.21
Code List
ER Status (check one)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
PgR Status (check one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
CL.22
Code List
PgR Status (check one)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PregnancyTestPerformedInd-2
Item
Pregnancy test done (check one)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
Item
Reason pregnancy test not performed (If no check one)
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.24
Code List
Reason pregnancy test not performed (If no check one)
CL Item
Patient Is Female But Is Not Of Childbearing Potential (Patient is female but is not of childbearing potential)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PregnancyLaboratoryProcedureNotPerformedSpecify
Item
Other, specify
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LastMenstrualCycleOnsetDate
Item
Date of Onset of Most Recent Menstrual Period (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C0025329 (NCI Metathesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Laboratory Procedure Date
Item
Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
DataUnknownText
Item
Not Applicable (Patient is post-menopausal)
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 Group
Ultrasound/mammogram
LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2
Item
Is oncotype analysis planned (check one)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
Item
Is adequate tumor volume present (If yes check one)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25335 (NCI Thesaurus Property-2)
C0449468 (UMLS 2011AA Property-2)
CL.26
Code List
Is adequate tumor volume present (If yes check one)
CL Item
Cannot Undergo Cryoablation (Cannot undergo cryoablation)
CL Item
Need Additional Cores (Need additional cores)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DiagnosticImagingUltrasoundImagingPerformedDate
Item
Date of Ultrasound (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17230 (NCI Thesaurus Property-2)
C0041618 (UMLS 2011AA Property-2)
TumorSecondDimensionMeasurement
Item
Dimension 2 (Tumor size width cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorSecondDimensionMeasurement
Item
Dimension 2 (Tumor size width cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorThirdDimensionMeasurement
Item
Dimension 3 (Tumor size depth cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25260 (NCI Thesaurus Property)
C0205437 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorThirdDimensionMeasurement
Item
Dimension 3 (Tumor size depth cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25260 (NCI Thesaurus Property)
C0205437 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
MammogramPerformedDate
Item
Date of mammogram (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
TumorLargestDimensionMeasurement
Item
Dimension 1 (Tumor size length cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorLargestDimensionMeasurement
Item
Dimension 1 (Tumor size length cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
Item
Calcifications (check one)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C20178 (NCI Thesaurus Property)
C0024671 (UMLS 2011AA Property)
C8433 (NCI Thesaurus Property-2)
C0520594 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.27
Code List
Calcifications (check one)
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present (Present)
C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)
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