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42992

Descrizione

ACOSOG-Z1031 OPEN Registration Worksheet Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8036B060-D675-EB4B-E040-BB89AD434531

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8036B060-D675-EB4B-E040-BB89AD434531

Keywords

  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 17/09/21 17/09/21 -
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17 settembre 2021

DOI

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Creative Commons BY-NC 3.0 Legacy

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    Endometrial Cancer NCT00265759 Registration - ACOSOG-Z1031 OPEN Registration Worksheet - 3014513v1.0

    No Instruction available.

    1. StudyEvent: ACOSOG-Z1031 OPEN Registration Worksheet
      1. No Instruction available.
    Header Module
    Descrizione

    Header Module

    Institution CTEP ID
    Descrizione

    TreatingInstitutionTextCode

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25705
    UMLS 2011AA ObjectClass
    C1522326
    NCI Thesaurus ObjectClass-2
    C19992
    UMLS 2011AA ObjectClass-2
    C1516607
    NCI Metathesaurus Property
    CL281747
    Institution Name
    Descrizione

    Institution Name

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Protocol Number
    Descrizione

    Protocol ID ACOSOG

    Tipo di dati

    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
    Protocol Title
    Descrizione

    Protocol Title

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986303
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus Property
    C42774
    Registration Step
    Descrizione

    Registration Number

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Treating Investigator
    Descrizione

    TreatingPhysicianOrParticipatingInvestigatorName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass-2
    C37998
    UMLS 2011AA ObjectClass-2
    C1518602
    NCI Thesaurus ObjectClass-3
    C51883
    UMLS 2011AA ObjectClass-3
    C1710470
    NCI Thesaurus ObjectClass-4
    C25936
    UMLS 2011AA ObjectClass-4
    C0035173
    NCI Thesaurus Property
    C25191
    UMLS 2011AA Property
    C1547383
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Site Registrar
    Descrizione

    Protocol Registrar

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS CUI-2
    C0557514
    NCI Thesaurus ObjectClass
    C25357
    Cooperative Group (Credit)
    Descrizione

    ClinicalTrialsCooperativeGroupRegisteringInstitutionIdentifierCode

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C41206
    UMLS 2011AA ObjectClass
    C1272753
    NCI Thesaurus ObjectClass-2
    C25645
    NCI Thesaurus ObjectClass-3
    C18205
    UMLS 2011AA ObjectClass-2
    C1521808
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    Investigator (Credit)
    Descrizione

    InvestigatorName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Comments (Enter case notes optional)
    Descrizione

    Research Comments

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Patient Information
    Descrizione

    Patient Information

    Date of Birth (month day year)
    Descrizione

    PersonBirthDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    Gender of a Person
    Descrizione

    PersonGenderTextType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C17357
    UMLS 2011AA Property
    C0079399
    Ethnicity
    Descrizione

    EthnicGroupCategoryText

    Tipo di dati

    text

    Alias
    NCI Thesaurus Property
    C25372
    UMLS 2011AA Property
    C0683312
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16564
    UMLS 2011AA ObjectClass
    C0015031
    Country of Residence
    Descrizione

    PersonAddressCountryName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ValueDomain
    C25464
    UMLS 2011AA ValueDomain
    C0454664
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    NCI Thesaurus ValueDomain-2
    C42614
    UMLS 2011AA ValueDomain-2
    C0027365
    Zip code
    Descrizione

    PersonAddressPostalCode

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Race
    Descrizione

    Racial Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0034510
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    Method of Payment
    Descrizione

    PatientPaymentType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    General Information
    Descrizione

    General Information

    Pt ID# (Local Patient Identifier)
    Descrizione

    PatientIdentifier

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25364
    UMLS 2011AA ValueDomain
    C0600091
    Last (initial)
    Descrizione

    Patient Initials Last

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1517741
    NCI Thesaurus Property
    C25536
    NCI Thesaurus Property-2
    C25551
    First (initial)
    Descrizione

    Patient Initials First

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C0205435
    NCI Thesaurus Property
    C25536
    NCI Thesaurus Property-2
    C25509
    Middle (initial optional)
    Descrizione

    PatientMiddleInitialsName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    NCI Thesaurus Property-2
    C25569
    UMLS 2011AA Property-2
    C0444598
    E-mail (for Registration Confirmation)
    Descrizione

    ResponsiblePersonE-mailAddressText

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C42775
    UMLS 2011AA Property
    C1705961
    Has patient previously been registered to an ACOSOG study
    Descrizione

    PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C16124
    UMLS 2011AA ObjectClass-2
    C1514463
    NCI Thesaurus Property
    C19712
    UMLS 2011AA Property
    C1515944
    NCI Metathesaurus Property
    CL238692
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)
    Descrizione

    Patient Study ID

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Date Informed Consent Signed (month day year)
    Descrizione

    InformedConsentFormSignedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Was HIPAA Authorization included in Study Informed Consent (mark one)
    Descrizione

    HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C62504
    UMLS 2011AA ObjectClass
    C0600593
    NCI Thesaurus Property
    C41192
    UMLS 2011AA Property
    C1524004
    HIPAA Authorization Date (If no month day year)
    Descrizione

    PatientSignedDischargeMedicalRecordDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25679
    NCI Metathesaurus Property
    C0012621
    NCI Thesaurus Property-2
    C45258
    UMLS 2011AA Property
    C0025102
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Patient must have an ECOG performance status of <= 2 (Zubrod)
    Descrizione

    EasternCooperativeOncologyGroupPerformanceStatusAssessmentIndicator

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C25491
    UMLS 2011AA ObjectClass
    C1512162
    NCI Metathesaurus ObjectClass
    CL092952
    ECOG Performance Status (Zubrod 0, 1, 2)
    Descrizione

    ECOG Performance Status

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension)
    Descrizione

    PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25581
    UMLS 2011AA Property
    C1518419
    NCI Thesaurus Property-2
    C25411
    UMLS 2011AA Property-2
    C0205179
    NCI Thesaurus Property-3
    C4872
    UMLS 2011AA Property-3
    C0678222
    NCI Thesaurus Property-4
    C25171
    UMLS 2011AA Property-4
    C0013893
    NCI Thesaurus Property-5
    C19987
    UMLS 2011AA Property-5
    C0242656
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
    Descrizione

    PatientMenopauseInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3231
    UMLS 2011AA Property
    C0025320
    Patient, as documented by the treating physician, is clinically staged as one of the following T4 a-c for whom modified radical mastectomy with negative margins is the goal, T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal, T2 for whom lumpectomy at first attempt is the goal
    Descrizione

    PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25411
    UMLS 2011AA Property-2
    C0205179
    NCI Thesaurus Property-3
    C9305
    UMLS 2011AA Property-3
    C0006826
    NCI Thesaurus Property-4
    C25629
    UMLS 2011AA Property-4
    C0332152
    NCI Thesaurus Property-5
    C25171
    UMLS 2011AA Property-5
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient has an ER+ tumor with an Allred score of 6, 7 or 8 (Note: Patients with >66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
    Descrizione

    BreastCarcinomaTumorMarkerPositiveFindingEstrogenReceptorStatusInd-3

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C4872
    UMLS 2011AA ObjectClass
    C0678222
    NCI Thesaurus ObjectClass-2
    C17220
    UMLS 2011AA ObjectClass-2
    C0041365
    NCI Thesaurus Property
    C38758
    UMLS 2011AA Property
    C1514241
    NCI Thesaurus Property-2
    C16150
    UMLS 2011AA Property-2
    C1516974
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Patient must have mammogram and ultrasound within 42 days prior to registration
    Descrizione

    MammogramPerformedInd-3

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C20178
    UMLS 2011AA ObjectClass
    C0024671
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    Date of mammogram (<= 42 days prior to registration mm/dd/yyyy)
    Descrizione

    MammogramPerformedDate

    Tipo di dati

    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
    Date of Ultrasound (<= 42 days prior to registration mm/dd/yyyy)
    Descrizione

    DiagnosticImagingUltrasoundImagingPerformedDate

    Tipo di dati

    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
    If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
    Descrizione

    PriorCancerDiagnosisIndicator

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
    Descrizione

    DermalLymphaticsInvasionInd-3

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25478
    UMLS 2011AA ObjectClass
    C0221928
    NCI Thesaurus ObjectClass-2
    C12746
    UMLS 2011AA ObjectClass-2
    C0024235
    NCI Thesaurus Property
    C20625
    UMLS 2011AA Property
    C1269955
    Prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent (Patients whose diagnosis was established by incisional biopsy are not eligible)
    Descrizione

    PriorCancerTreatmentInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Thesaurus Property
    C49236
    UMLS 2011AA Property
    C0087111
    Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
    Descrizione

    PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C15445
    UMLS 2011AA Property
    C0279025
    NCI Thesaurus Property-2
    C4872
    UMLS 2011AA Property-2
    C0678222
    NCI Thesaurus Property-3
    C25171
    UMLS 2011AA Property-3
    C0013893
    NCI Thesaurus Property-4
    C25382
    UMLS 2011AA Property-4
    C1521801
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
    Descrizione

    DistantMetastasisPresentInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ObjectClass
    C25321
    UMLS 2011AA ObjectClass
    C0443203
    NCI Thesaurus ObjectClass-2
    C19151
    UMLS 2011AA ObjectClass-2
    C0027627
    Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
    Descrizione

    TotalMastectomyPerformedInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C15281
    UMLS 2011AA ObjectClass
    C0024886
    Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
    Descrizione

    PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator

    Tipo di dati

    boolean

    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
    Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
    Descrizione

    SentinelNodeBiopsyInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Randomization
    Descrizione

    Randomization

    Treatment Arm
    Descrizione

    AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    NCI Thesaurus ObjectClass
    C19712
    UMLS 2011AA ObjectClass
    C1515944
    NCI Thesaurus ObjectClass-2
    C15538
    UMLS 2011AA ObjectClass-2
    C1522541

    Similar models

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    1. StudyEvent: ACOSOG-Z1031 OPEN Registration Worksheet
      1. No Instruction available.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header Module
    TreatingInstitutionTextCode
    Item
    Institution CTEP ID
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25705 (NCI Thesaurus ObjectClass)
    C1522326 (UMLS 2011AA ObjectClass)
    C19992 (NCI Thesaurus ObjectClass-2)
    C1516607 (UMLS 2011AA ObjectClass-2)
    CL281747 (NCI Metathesaurus Property)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    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)
    Protocol Title
    Item
    Protocol Title
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986303 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C42774 (NCI Thesaurus Property)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    TreatingPhysicianOrParticipatingInvestigatorName
    Item
    Treating Investigator
    text
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C37998 (NCI Thesaurus ObjectClass-2)
    C1518602 (UMLS 2011AA ObjectClass-2)
    C51883 (NCI Thesaurus ObjectClass-3)
    C1710470 (UMLS 2011AA ObjectClass-3)
    C25936 (NCI Thesaurus ObjectClass-4)
    C0035173 (UMLS 2011AA ObjectClass-4)
    C25191 (NCI Thesaurus Property)
    C1547383 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    Protocol Registrar
    Item
    Site Registrar
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1507394 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C0557514 (UMLS CUI-2)
    C25357 (NCI Thesaurus ObjectClass)
    ClinicalTrialsCooperativeGroupRegisteringInstitutionIdentifierCode
    Item
    Cooperative Group (Credit)
    text
    C41206 (NCI Thesaurus ObjectClass)
    C1272753 (UMLS 2011AA ObjectClass)
    C25645 (NCI Thesaurus ObjectClass-2)
    C18205 (NCI Thesaurus ObjectClass-3)
    C1521808 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    InvestigatorName
    Item
    Investigator (Credit)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    Research Comments
    Item
    Comments (Enter case notes optional)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Item Group
    Patient Information
    PersonBirthDate
    Item
    Date of Birth (month day year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA Property)
    Item
    Gender of a Person
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C17357 (NCI Thesaurus Property)
    C0079399 (UMLS 2011AA Property)
    Code List
    Gender of a Person
    CL Item
    Female Gender (Female)
    C46110 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    CL Item
    Male Gender (Male)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Ethnicity
    text
    C25372 (NCI Thesaurus Property)
    C0683312 (UMLS 2011AA Property)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16564 (NCI Thesaurus ObjectClass)
    C0015031 (UMLS 2011AA ObjectClass)
    Code List
    Ethnicity
    CL Item
    A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
    C17459 (NCI Thesaurus)
    C0086409 (UMLS 2011AA)
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    PersonAddressCountryName
    Item
    Country of Residence
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25464 (NCI Thesaurus ValueDomain)
    C0454664 (UMLS 2011AA ValueDomain)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    C0027365 (UMLS 2011AA ValueDomain-2)
    PersonAddressPostalCode
    Item
    Zip code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    Item
    Race
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    Code List
    Race
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not Reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Method of Payment
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    Code List
    Method of Payment
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    General Information
    PatientIdentifier
    Item
    Pt ID# (Local Patient Identifier)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus ValueDomain)
    C0600091 (UMLS 2011AA ValueDomain)
    Patient Initials Last
    Item
    Last (initial)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1517741 (UMLS CUI-2)
    C25536 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    Patient Initials First
    Item
    First (initial)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C0205435 (UMLS CUI-2)
    C25536 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    PatientMiddleInitialsName
    Item
    Middle (initial optional)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    C25569 (NCI Thesaurus Property-2)
    C0444598 (UMLS 2011AA Property-2)
    ResponsiblePersonE-mailAddressText
    Item
    E-mail (for Registration Confirmation)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C42775 (NCI Thesaurus Property)
    C1705961 (UMLS 2011AA Property)
    PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
    Item
    Has patient previously been registered to an ACOSOG study
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16124 (NCI Thesaurus ObjectClass-2)
    C1514463 (UMLS 2011AA ObjectClass-2)
    C19712 (NCI Thesaurus Property)
    C1515944 (UMLS 2011AA Property)
    CL238692 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Patient Study ID
    Item
    Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (month day year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
    Item
    Was HIPAA Authorization included in Study Informed Consent (mark one)
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C62504 (NCI Thesaurus ObjectClass)
    C0600593 (UMLS 2011AA ObjectClass)
    C41192 (NCI Thesaurus Property)
    C1524004 (UMLS 2011AA Property)
    PatientSignedDischargeMedicalRecordDate
    Item
    HIPAA Authorization Date (If no month day year)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    C0012621 (NCI Metathesaurus Property)
    C45258 (NCI Thesaurus Property-2)
    C0025102 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Item Group
    Inclusion Criteria
    EasternCooperativeOncologyGroupPerformanceStatusAssessmentIndicator
    Item
    Patient must have an ECOG performance status of <= 2 (Zubrod)
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS 2011AA ObjectClass)
    CL092952 (NCI Metathesaurus ObjectClass)
    Item
    ECOG Performance Status (Zubrod 0, 1, 2)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    Code List
    ECOG Performance Status (Zubrod 0, 1, 2)
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2
    Item
    Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25581 (NCI Thesaurus Property)
    C1518419 (UMLS 2011AA Property)
    C25411 (NCI Thesaurus Property-2)
    C0205179 (UMLS 2011AA Property-2)
    C4872 (NCI Thesaurus Property-3)
    C0678222 (UMLS 2011AA Property-3)
    C25171 (NCI Thesaurus Property-4)
    C0013893 (UMLS 2011AA Property-4)
    C19987 (NCI Thesaurus Property-5)
    C0242656 (UMLS 2011AA Property-5)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientMenopauseInd-2
    Item
    Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3231 (NCI Thesaurus Property)
    C0025320 (UMLS 2011AA Property)
    PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2
    Item
    Patient, as documented by the treating physician, is clinically staged as one of the following T4 a-c for whom modified radical mastectomy with negative margins is the goal, T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal, T2 for whom lumpectomy at first attempt is the goal
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25411 (NCI Thesaurus Property-2)
    C0205179 (UMLS 2011AA Property-2)
    C9305 (NCI Thesaurus Property-3)
    C0006826 (UMLS 2011AA Property-3)
    C25629 (NCI Thesaurus Property-4)
    C0332152 (UMLS 2011AA Property-4)
    C25171 (NCI Thesaurus Property-5)
    C0013893 (UMLS 2011AA Property-5)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    BreastCarcinomaTumorMarkerPositiveFindingEstrogenReceptorStatusInd-3
    Item
    Patient has an ER+ tumor with an Allred score of 6, 7 or 8 (Note: Patients with >66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
    boolean
    C4872 (NCI Thesaurus ObjectClass)
    C0678222 (UMLS 2011AA ObjectClass)
    C17220 (NCI Thesaurus ObjectClass-2)
    C0041365 (UMLS 2011AA ObjectClass-2)
    C38758 (NCI Thesaurus Property)
    C1514241 (UMLS 2011AA Property)
    C16150 (NCI Thesaurus Property-2)
    C1516974 (UMLS 2011AA Property-2)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    MammogramPerformedInd-3
    Item
    Patient must have mammogram and ultrasound within 42 days prior to registration
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C20178 (NCI Thesaurus ObjectClass)
    C0024671 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    MammogramPerformedDate
    Item
    Date of mammogram (<= 42 days prior to registration 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)
    DiagnosticImagingUltrasoundImagingPerformedDate
    Item
    Date of Ultrasound (<= 42 days prior to registration 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)
    Item
    If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Code List
    If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Applicable (NA)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item Group
    Exclusion Criteria
    DermalLymphaticsInvasionInd-3
    Item
    Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25478 (NCI Thesaurus ObjectClass)
    C0221928 (UMLS 2011AA ObjectClass)
    C12746 (NCI Thesaurus ObjectClass-2)
    C0024235 (UMLS 2011AA ObjectClass-2)
    C20625 (NCI Thesaurus Property)
    C1269955 (UMLS 2011AA Property)
    PriorCancerTreatmentInd-2
    Item
    Prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent (Patients whose diagnosis was established by incisional biopsy are not eligible)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C49236 (NCI Thesaurus Property)
    C0087111 (UMLS 2011AA Property)
    PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
    Item
    Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C15445 (NCI Thesaurus Property)
    C0279025 (UMLS 2011AA Property)
    C4872 (NCI Thesaurus Property-2)
    C0678222 (UMLS 2011AA Property-2)
    C25171 (NCI Thesaurus Property-3)
    C0013893 (UMLS 2011AA Property-3)
    C25382 (NCI Thesaurus Property-4)
    C1521801 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    DistantMetastasisPresentInd-2
    Item
    Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25321 (NCI Thesaurus ObjectClass)
    C0443203 (UMLS 2011AA ObjectClass)
    C19151 (NCI Thesaurus ObjectClass-2)
    C0027627 (UMLS 2011AA ObjectClass-2)
    TotalMastectomyPerformedInd-2
    Item
    Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C15281 (NCI Thesaurus ObjectClass)
    C0024886 (UMLS 2011AA ObjectClass)
    PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator
    Item
    Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
    boolean
    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)
    SentinelNodeBiopsyInd-2
    Item
    Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    Item Group
    Randomization
    Item
    Treatment Arm
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    C19712 (NCI Thesaurus ObjectClass)
    C1515944 (UMLS 2011AA ObjectClass)
    C15538 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS 2011AA ObjectClass-2)
    Code List
    Treatment Arm
    CL Item
    Patient Chosen Arm (Patient chosen arm)

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