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ID

8933

Descrição

Confirmation of Registration Form (Form 25-A) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD163BF2-874D-4FBE-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD163BF2-874D-4FBE-E034-0003BA12F5E7

Palavras-chave

  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Transferido a

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT00066703 Registration - Confirmation of Registration Form (Form 25-A) - 2168101v3.0

    No Instruction available.

    1. StudyEvent: Confirmation of Registration Form (Form 25-A)
      1. No Instruction available.
    Ccrr Module For Registration Form (form 25-a)
    Descrição

    Ccrr Module For Registration Form (form 25-a)

    Patient ID No.
    Descrição

    PatientStudyID,CoordinatingGroup

    Tipo de dados

    text

    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient's Date of Birth
    Descrição

    Birth Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0421451
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    Participating Center/Affiliate
    Descrição

    ParticipatingCenter/Affiliate

    Tipo de dados

    text

    Center Code
    Descrição

    ParticipatingGroupCode

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    PMD Code
    Descrição

    PMDCode

    Tipo de dados

    text

    Premenopausal
    Descrição

    Premenopausal

    Tipo de dados

    boolean

    Randomized within 12 weeks after definite surgery prior to commencing any adjuvant systemic therapy
    Descrição

    Randomizedwithin12weeksafterdefinitesurgerypriortocommencinganyadjuvantsystemictherapy

    Tipo de dados

    boolean

    Histologically proven, resected breast cancer
    Descrição

    Histologicallyproven,resectedbreastcancer

    Tipo de dados

    boolean

    Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation
    Descrição

    Estrogenand/orprogesteronereceptorPostitivetumorwhichisdefinedas>or=10%oftumorcellspositivebyimmunohistochemicalevaluation

    Tipo de dados

    boolean

    The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure.
    Descrição

    Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.

    Tipo de dados

    boolean

    Total mastectomy OR breast-conserving procedure with radiotherapy to the conserved breast planned. Margins must be clear of invasive cancer and DCIS. Documented clear margins of resection in pathology report.
    Descrição

    TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

    Tipo de dados

    boolean

    Either axillary lymph node dissection OR negative axillary node biopsy and workup.
    Descrição

    EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.

    Tipo de dados

    boolean

    No locally advanced inoperable or inflammatory breast cancer
    Descrição

    Nolocallyadvancedinoperableorinflammatorybreastcancer

    Tipo de dados

    boolean

    no bilateral invasive breast cancer.
    Descrição

    Nobilateralinvasivebreastcancer.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Final margins negative
    Descrição

    Finalmarginsnegative

    Tipo de dados

    boolean

    No clinically detectable residual axillary disease.
    Descrição

    Noclinicallydetectableresidualaxillarydisease.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
    Descrição

    Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.

    Tipo de dados

    boolean

    No history of prior ipsilateral or contralateral invasive breast cancer.
    Descrição

    Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    No previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma.
    Descrição

    NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.

    Tipo de dados

    boolean

    No non-malignant systemic diseases that would prevent prolonged follow-up.
    Descrição

    Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    No prior bilateral oophorectomy or ovarian reduction.
    Descrição

    Nopriorbilateraloophorectomyorovarianreduction.

    Tipo de dados

    boolean

    No history of noncompliance to medical regimens and no considered potentially unreliable.
    Descrição

    Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.

    Tipo de dados

    boolean

    Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
    Descrição

    Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
    Descrição

    Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    No endocrine therapy after breast cancer diagnosis.
    Descrição

    Noendocrinetherapyafterbreastcancerdiagnosis.

    Tipo de dados

    boolean

    No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
    Descrição

    NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.

    Tipo de dados

    boolean

    No neoadjuvant or adjuvant chemotherapy.
    Descrição

    Noneoadjuvantoradjuvantchemotherapy.

    Tipo de dados

    boolean

    No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study.
    Descrição

    Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

    Tipo de dados

    boolean

    Accessible for follow-up.
    Descrição

    Accessibleforfollow-up.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
    Descrição

    Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Are all answers to the Eligibility Checklist YES?
    Descrição

    AreallanswerstotheEligibilityChecklistYES?

    Tipo de dados

    boolean

    Has informed consent form been signed and dated by the patient and investigator?
    Descrição

    Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Date informed consent form signed by patient
    Descrição

    DateInformedConsentFormsignedbypatient

    Tipo de dados

    text

    Date informed consent form signed by investigator
    Descrição

    DateInformedConsentFormsignedbyInvestigator

    Tipo de dados

    text

    Is protocol-required pathology material available
    Descrição

    SpecimenCollectedIBCSGStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25452
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    give reason
    Descrição

    SpecimenCollectedIBCSGSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25452
    Have baseline QL Core and module forms been completed?
    Descrição

    HavebaselineQLCoreandmoduleformsbeencompleted?

    Tipo de dados

    text

    Other reason, specify (QL forms not completed)
    Descrição

    no,otherreason,specify(QLformsnotcompleted)

    Tipo de dados

    text

    Date baseline QL forms were completed
    Descrição

    DatebaselineQLformswerecompleted

    Tipo de dados

    text

    Was the patient randomized to Trial 26-02
    Descrição

    PatientRandomizationIBCSGInd-2

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    NCI Metathesaurus ObjectClass
    C0030705
    Will adjuvant chemotherapy be given?
    Descrição

    Willadjuvantchemotherapybegiven?

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Projected Treatment Begin Date
    Descrição

    ProjectedTreatmentBeginDate

    Tipo de dados

    date

    Tumor Laterality
    Descrição

    PrimaryTumorLateralityType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C25251
    UMLS 2011AA ObjectClass-2
    C0205225
    NCI Thesaurus Property
    C25185
    UMLS 2011AA Property
    C0332304
    Right Breast/Side
    Descrição

    RightBreastLymphNodeAssessmentStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25228
    UMLS 2011AA ObjectClass
    C0205090
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus ObjectClass-3
    C12745
    UMLS 2011AA ObjectClass-3
    C0024204
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Left Breast/Side
    Descrição

    LeftBreastLymphNodeAssessmentStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25229
    UMLS 2011AA ObjectClass
    C0205091
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus ObjectClass-3
    C12745
    UMLS 2011AA ObjectClass-3
    C0024204
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Date of Most Extensive Primary Surgery (Left breast/side)
    Descrição

    PrimarySurgeryDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ObjectClass
    C25251
    UMLS 2011AA ObjectClass
    C0205225
    NCI Thesaurus ObjectClass-2
    C15329
    UMLS 2011AA ObjectClass-2
    C0543467
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Date of Most Extensive Primary Surgery (Left breast/side)
    Descrição

    PrimarySurgeryDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ObjectClass
    C25251
    UMLS 2011AA ObjectClass
    C0205225
    NCI Thesaurus ObjectClass-2
    C15329
    UMLS 2011AA ObjectClass-2
    C0543467
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Most Extensive Primary Surgery (Right breast/side)
    Descrição

    PrimarySurgeryType

    Tipo de dados

    text

    Most Extensive Primary Surgery (Right breast/side)
    Descrição

    PrimarySurgeryType

    Tipo de dados

    text

    Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
    Descrição

    Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

    Tipo de dados

    boolean

    Specimen ID Number (Right breast/side)
    Descrição

    SpecimenIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    Specimen ID Number (Left breast/side)
    Descrição

    SpecimenID

    Tipo de dados

    float

    Lab Facility Name
    Descrição

    SpecimenLabIdentifierName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C37984
    UMLS 2011AA ObjectClass
    C0022877
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    Pathology Institute Code
    Descrição

    PathologyInstituteCode

    Tipo de dados

    text

    Full name of person randomizing at Participating Center
    Descrição

    RandomizationPersonName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass-2
    C25196
    UMLS 2011AA ObjectClass-2
    C0034656
    Fax Number
    Descrição

    PersonFaxNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    NCI Thesaurus ValueDomain-2
    C25210
    UMLS 2011AA ValueDomain-2
    C0085205
    Phone Number
    Descrição

    OrganizationPhoneNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    NCI Thesaurus ObjectClass
    C19711
    UMLS 2011AA ObjectClass
    C1522486
    Full name of investigator responsible for confirming eligibility
    Descrição

    Fullnameofinvestigatorresponsibleforconfirmingeligibility

    Tipo de dados

    text

    Treating physician
    Descrição

    TreatingPhysicianName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25741
    UMLS 2011AA ObjectClass
    C0031831
    NCI Thesaurus ObjectClass-2
    C25705
    UMLS 2011AA ObjectClass-2
    C1522326
    IBCSG Patient ID
    Descrição

    PatientInternationalBreastCancerStudyGroupIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25530
    UMLS 2011AA Property-2
    C1512890
    Assigned Treatment Arm
    Descrição

    TreatmentArmIBCSGType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C32141
    UMLS 2011AA Property
    C1140618
    NCI Thesaurus ObjectClass
    C15368
    Randomization Date
    Descrição

    ProtocolRandomizationDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    Name of person who perfomed randomization at Randomization Center
    Descrição

    NameofpersonwhoperfomedrandomizationatRandomizationCenter

    Tipo de dados

    text

    NCI Investigator Number Code
    Descrição

    NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C19202
    UMLS 2011AA ObjectClass
    C1513882
    NCI Thesaurus ObjectClass-2
    C19924
    UMLS 2011AA ObjectClass-2
    C1521895
    Investigator Signature
    Descrição

    Investigator Signature

    Tipo de dados

    text

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

    Investigator Signature Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089

    Similar models

    No Instruction available.

    1. StudyEvent: Confirmation of Registration Form (Form 25-A)
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Ccrr Module For Registration Form (form 25-a)
    PatientStudyID,CoordinatingGroup
    Item
    Patient ID No.
    text
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Birth Date
    Item
    Patient's Date of Birth
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0421451 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    ParticipatingCenter/Affiliate
    Item
    Participating Center/Affiliate
    text
    ParticipatingGroupCode
    Item
    Center Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    PMDCode
    Item
    PMD Code
    text
    Premenopausal
    Item
    Premenopausal
    boolean
    Randomizedwithin12weeksafterdefinitesurgerypriortocommencinganyadjuvantsystemictherapy
    Item
    Randomized within 12 weeks after definite surgery prior to commencing any adjuvant systemic therapy
    boolean
    Histologicallyproven,resectedbreastcancer
    Item
    Histologically proven, resected breast cancer
    boolean
    Estrogenand/orprogesteronereceptorPostitivetumorwhichisdefinedas>or=10%oftumorcellspositivebyimmunohistochemicalevaluation
    Item
    Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation
    boolean
    Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.
    Item
    The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure.
    boolean
    TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.
    Item
    Total mastectomy OR breast-conserving procedure with radiotherapy to the conserved breast planned. Margins must be clear of invasive cancer and DCIS. Documented clear margins of resection in pathology report.
    boolean
    EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.
    Item
    Either axillary lymph node dissection OR negative axillary node biopsy and workup.
    boolean
    Nolocallyadvancedinoperableorinflammatorybreastcancer
    Item
    No locally advanced inoperable or inflammatory breast cancer
    boolean
    Nobilateralinvasivebreastcancer.
    Item
    no bilateral invasive breast cancer.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Finalmarginsnegative
    Item
    Final margins negative
    boolean
    Noclinicallydetectableresidualaxillarydisease.
    Item
    No clinically detectable residual axillary disease.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.
    Item
    No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
    boolean
    Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.
    Item
    No history of prior ipsilateral or contralateral invasive breast cancer.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.
    Item
    No previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma.
    boolean
    Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.
    Item
    No non-malignant systemic diseases that would prevent prolonged follow-up.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Nopriorbilateraloophorectomyorovarianreduction.
    Item
    No prior bilateral oophorectomy or ovarian reduction.
    boolean
    Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.
    Item
    No history of noncompliance to medical regimens and no considered potentially unreliable.
    boolean
    Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.
    Item
    Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.
    Item
    Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Noendocrinetherapyafterbreastcancerdiagnosis.
    Item
    No endocrine therapy after breast cancer diagnosis.
    boolean
    NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.
    Item
    No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
    boolean
    Noneoadjuvantoradjuvantchemotherapy.
    Item
    No neoadjuvant or adjuvant chemotherapy.
    boolean
    Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.
    Item
    No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study.
    boolean
    Accessibleforfollow-up.
    Item
    Accessible for follow-up.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.
    Item
    Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    AreallanswerstotheEligibilityChecklistYES?
    Item
    Are all answers to the Eligibility Checklist YES?
    boolean
    Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?
    Item
    Has informed consent form been signed and dated by the patient and investigator?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    DateInformedConsentFormsignedbypatient
    Item
    Date informed consent form signed by patient
    text
    DateInformedConsentFormsignedbyInvestigator
    Item
    Date informed consent form signed by investigator
    text
    Item
    Is protocol-required pathology material available
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Is protocol-required pathology material available
    CL Item
    Available Now (Available now)
    CL Item
    Available Within 3 Months (Available within 3 months)
    CL Item
    Not Available (Not available)
    SpecimenCollectedIBCSGSpecify
    Item
    give reason
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus Property)
    Item
    Have baseline QL Core and module forms been completed?
    text
    Code List
    Have baseline QL Core and module forms been completed?
    CL Item
    No, Patient Meets Exception Criterial Listed In Protocol (no, patient meets exception criterial listed in protocol)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No, But We Intend To Present Baseline Ql Forms To Be Completed By The Patient Prior To Starting Theray (no, BUT we intend to present baseline QL forms to be completed by the patient prior to starting theray)
    CL Item
    No, Other Reason, Specify (no, other reason, specify)
    no,otherreason,specify(QLformsnotcompleted)
    Item
    Other reason, specify (QL forms not completed)
    text
    DatebaselineQLformswerecompleted
    Item
    Date baseline QL forms were completed
    text
    PatientRandomizationIBCSGInd-2
    Item
    Was the patient randomized to Trial 26-02
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    C0030705 (NCI Metathesaurus ObjectClass)
    Willadjuvantchemotherapybegiven?
    Item
    Will adjuvant chemotherapy be given?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    ProjectedTreatmentBeginDate
    Item
    Projected Treatment Begin Date
    date
    Item
    Tumor Laterality
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25251 (NCI Thesaurus ObjectClass-2)
    C0205225 (UMLS 2011AA ObjectClass-2)
    C25185 (NCI Thesaurus Property)
    C0332304 (UMLS 2011AA Property)
    Code List
    Tumor Laterality
    CL Item
    Bilateral (Bilateral)
    C13332 (NCI Thesaurus)
    C0238767 (UMLS 2011AA)
    CL Item
    Left (Left)
    C25229 (NCI Thesaurus)
    C0205091 (UMLS 2011AA)
    CL Item
    Right (Right)
    C25228 (NCI Thesaurus)
    C0205090 (UMLS 2011AA)
    Item
    Right Breast/Side
    text
    C25228 (NCI Thesaurus ObjectClass)
    C0205090 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C12745 (NCI Thesaurus ObjectClass-3)
    C0024204 (UMLS 2011AA ObjectClass-3)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Right Breast/Side
    CL Item
    0 (0)
    C0919414 (NCI Metathesaurus)
    CL Item
    1 (1)
    Item
    Left Breast/Side
    text
    C25229 (NCI Thesaurus ObjectClass)
    C0205091 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C12745 (NCI Thesaurus ObjectClass-3)
    C0024204 (UMLS 2011AA ObjectClass-3)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Left Breast/Side
    CL Item
    0 (0)
    C0919414 (NCI Metathesaurus)
    CL Item
    1 (1)
    PrimarySurgeryDate
    Item
    Date of Most Extensive Primary Surgery (Left breast/side)
    date
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass-2)
    C0543467 (UMLS 2011AA ObjectClass-2)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    PrimarySurgeryDate
    Item
    Date of Most Extensive Primary Surgery (Left breast/side)
    date
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass-2)
    C0543467 (UMLS 2011AA ObjectClass-2)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Most Extensive Primary Surgery (Right breast/side)
    text
    Code List
    Most Extensive Primary Surgery (Right breast/side)
    CL Item
    Less Than Mastectomy (Less than mastectomy)
    CL Item
    Mastectomy (Mastectomy)
    C15277 (NCI Thesaurus)
    C0024881 (UMLS 2011AA)
    Item
    Most Extensive Primary Surgery (Right breast/side)
    text
    Code List
    Most Extensive Primary Surgery (Right breast/side)
    CL Item
    Less Than Mastectomy (Less than mastectomy)
    CL Item
    Mastectomy (Mastectomy)
    C15277 (NCI Thesaurus)
    C0024881 (UMLS 2011AA)
    Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
    Item
    Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
    boolean
    SpecimenIdentifierNumber
    Item
    Specimen ID Number (Right breast/side)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    SpecimenID
    Item
    Specimen ID Number (Left breast/side)
    float
    SpecimenLabIdentifierName
    Item
    Lab Facility Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus ObjectClass)
    C0022877 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    PathologyInstituteCode
    Item
    Pathology Institute Code
    text
    RandomizationPersonName
    Item
    Full name of person randomizing at Participating Center
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25196 (NCI Thesaurus ObjectClass-2)
    C0034656 (UMLS 2011AA ObjectClass-2)
    PersonFaxNumber
    Item
    Fax Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    C25210 (NCI Thesaurus ValueDomain-2)
    C0085205 (UMLS 2011AA ValueDomain-2)
    OrganizationPhoneNumber
    Item
    Phone Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    C19711 (NCI Thesaurus ObjectClass)
    C1522486 (UMLS 2011AA ObjectClass)
    Fullnameofinvestigatorresponsibleforconfirmingeligibility
    Item
    Full name of investigator responsible for confirming eligibility
    text
    TreatingPhysicianName
    Item
    Treating physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25741 (NCI Thesaurus ObjectClass)
    C0031831 (UMLS 2011AA ObjectClass)
    C25705 (NCI Thesaurus ObjectClass-2)
    C1522326 (UMLS 2011AA ObjectClass-2)
    PatientInternationalBreastCancerStudyGroupIdentifierNumber
    Item
    IBCSG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25530 (NCI Thesaurus Property-2)
    C1512890 (UMLS 2011AA Property-2)
    Item
    Assigned Treatment Arm
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C32141 (NCI Thesaurus Property)
    C1140618 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    Code List
    Assigned Treatment Arm
    CL Item
    Triptorelin For 5 Years Plus Exemestane For 5 Years (Triptorelin for 5 years plus Exemestane for 5 years)
    CL Item
    Triptorelin For 5 Years Plus Tamoxifen For 5 Years (Triptorelin for 5 years plus Tamoxifen for 5 years)
    ProtocolRandomizationDate
    Item
    Randomization Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    NameofpersonwhoperfomedrandomizationatRandomizationCenter
    Item
    Name of person who perfomed randomization at Randomization Center
    text
    NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText
    Item
    NCI Investigator Number Code
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19202 (NCI Thesaurus ObjectClass)
    C1513882 (UMLS 2011AA ObjectClass)
    C19924 (NCI Thesaurus ObjectClass-2)
    C1521895 (UMLS 2011AA ObjectClass-2)
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)

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