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7615

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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

Länk

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

Nyckelord

Versioner (3)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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

    Engelsk

    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 Formulär  
    Header Module
    Beskrivning

    Header Module

    Protocol Number
    Beskrivning

    Protocol ID ACOSOG

    Datatyp

    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
    Beskrivning

    Patient Study ID

    Datatyp

    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)
    Beskrivning

    Patient Initials

    Datatyp

    text

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

    Institution Number

    Datatyp

    text

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

    Institution Name

    Datatyp

    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)
    Beskrivning

    Data amended

    Datatyp

    boolean

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

    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)
    Beskrivning

    InvasiveBreastCarcinomaHistologicallyConfirmedIndicator

    Datatyp

    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
    Beskrivning

    BreastBiopsyIndicator

    Datatyp

    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)
    Beskrivning

    BreastCarcinomaTwoCentimeterPresentIndicator

    Datatyp

    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
    Beskrivning

    MeasurableDiseaseEnhancingLesionPresentIndicator

    Datatyp

    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
    Beskrivning

    TumorHistologicVariationIndicator

    Datatyp

    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
    Beskrivning

    PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator

    Datatyp

    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)
    Beskrivning

    PatientNegativePregnancyTestIndicator

    Datatyp

    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)
    Beskrivning

    BreastSizeDocumentedIndicator

    Datatyp

    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
    Beskrivning

    Instructions

    Patient consented to optional blood sample collection
    Beskrivning

    PatientOptionalConsentInd-2

    Datatyp

    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?
    Beskrivning

    BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Datatyp

    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?
    Beskrivning

    BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

    Datatyp

    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?
    Beskrivning

    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Datatyp

    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?
    Beskrivning

    TissueSpecimenResearchConsentUnrelatedInd-3

    Datatyp

    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
    Beskrivning

    PatientContactConsentInd-3

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property-2
    C1511481
    NCI Thesaurus Property-3
    C16452
    UMLS 2011AA Property-3
    C0009452
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Description Of Primary Disease
    Beskrivning

    Description Of Primary Disease

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

    MedDRACode

    Datatyp

    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)
    Beskrivning

    MalignantNeoplasmPrimarySiteText

    Datatyp

    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)
    Beskrivning

    BreastTumorHistologicCategory

    Datatyp

    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
    Beskrivning

    Histologic Type, other

    Datatyp

    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)
    Beskrivning

    BreastNeoplasmNuclearGradeCategory

    Datatyp

    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
    Beskrivning

    Biopsy Data

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

    SurgicalProcedureCoreBiopsyPerformedDate

    Datatyp

    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
    Beskrivning

    BiopsyNeedleBiopsyGaugePerformedValue

    Datatyp

    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)
    Beskrivning

    BiopsyMammotomeClipPlacementPerformedInd-2

    Datatyp

    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
    Beskrivning

    BiopsyMammotomeClipPlacementPerformedName

    Datatyp

    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 %)
    Beskrivning

    InvasiveBreastCarcinomaHistologicallyConfirmedCellPercentageValue

    Datatyp

    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)
    Beskrivning

    BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

    Datatyp

    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)
    Beskrivning

    FISHCytologyResultType

    Datatyp

    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)
    Beskrivning

    Laboratory Procedure Date

    Datatyp

    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)
    Beskrivning

    Laboratory Procedure Date

    Datatyp

    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
    Beskrivning

    Estrogen/progesterone Data

    ER Status (check one)
    Beskrivning

    ERLevelTumorStatus

    Datatyp

    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)
    Beskrivning

    PgRStatusType

    Datatyp

    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)
    Beskrivning

    PregnancyTestPerformedInd-2

    Datatyp

    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)
    Beskrivning

    PregnancyLaboratoryProcedureNotPerformedReason

    Datatyp

    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
    Beskrivning

    PregnancyLaboratoryProcedureNotPerformedSpecify

    Datatyp

    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)
    Beskrivning

    LastMenstrualCycleOnsetDate

    Datatyp

    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)
    Beskrivning

    Laboratory Procedure Date

    Datatyp

    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)
    Beskrivning

    Laboratory Procedure Date

    Datatyp

    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)
    Beskrivning

    DataUnknownText

    Datatyp

    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
    Beskrivning

    Ultrasound/mammogram

    Is oncotype analysis planned (check one)
    Beskrivning

    LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2

    Datatyp

    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)
    Beskrivning

    TumorTotalVolumeStatus

    Datatyp

    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)
    Beskrivning

    DiagnosticImagingUltrasoundImagingPerformedDate

    Datatyp

    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)
    Beskrivning

    TumorSecondDimensionMeasurement

    Datatyp

    float

    Måttenheter
    • 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)
    Beskrivning

    TumorSecondDimensionMeasurement

    Datatyp

    float

    Måttenheter
    • 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)
    Beskrivning

    TumorThirdDimensionMeasurement

    Datatyp

    float

    Måttenheter
    • 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)
    Beskrivning

    TumorThirdDimensionMeasurement

    Datatyp

    float

    Måttenheter
    • 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)
    Beskrivning

    MammogramPerformedDate

    Datatyp

    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)
    Beskrivning

    TumorLargestDimensionMeasurement

    Datatyp

    float

    Måttenheter
    • 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)
    Beskrivning

    TumorLargestDimensionMeasurement

    Datatyp

    float

    Måttenheter
    • 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)
    Beskrivning

    BreastMalignantNeoplasmMammogramMicrocalcificationStatus

    Datatyp

    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
    Tillbaka till toppen

    Similar models

    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 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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)
    PatientContactConsentInd-3
    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)
    C0030705 (UMLS 2011AA ObjectClass)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property-2)
    C16452 (NCI Thesaurus Property-3)
    C0009452 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA 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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