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ID

783

Description

Confirmation of Registration Form (Form 26-A) A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD162886-D685-4FAB-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD162886-D685-4FAB-E034-0003BA12F5E7

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT00066807 Registration - Confirmation of Registration Form (Form 26-A) - 2167967v3.0

    No Instruction available.

    1. StudyEvent: Confirmation of Registration Form (Form 26-A)
      1. No Instruction available.
    Ccrr Module For Registration Form (form 26 A)
    Description

    Ccrr Module For Registration Form (form 26 A)

    Patient ID No.
    Description

    PatientStudyID,CoordinatingGroup

    Data type

    text

    Patient Initials
    Description

    PatientInitialsName

    Data type

    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
    Patient's Date of Birth
    Description

    PatientBirthDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    Participating Center/Affiliate
    Description

    ParticipatingCenter/Affiliate

    Data type

    text

    Center Code
    Description

    ParticipatingGroupCode

    Data type

    text

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

    PMDCode

    Data type

    text

    Premenopausal
    Description

    Premenopausal

    Data type

    text

    Suitable for adding chemotherapy to the adjuvant systemic therapy
    Description

    Suitableforaddingchemotherapytotheadjuvantsystemictherapy

    Data type

    text

    Randomized within 12 weeks after definite surgery
    Description

    Randomizedwithin12weeksafterdefinitesurgery

    Data type

    text

    To be selected by subsequent randomization to the TEXT trial
    Description

    TobeselectedbysubsequentrandomizationtotheTEXTtrial

    Data type

    text

    Tamoxifen
    Description

    Tamoxifen

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Exemestane
    Description

    Exemestane

    Data type

    text

    Histologically proven, resected breast cancer
    Description

    Histologicallyproven,resectedbreastcancer

    Data type

    text

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

    Estrogenand/orprogesteronereceptorPostitivetumorwhichisdefinedas>or=10%oftumorcellspositivebyimmunohistochemicalevaluation

    Data type

    text

    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.
    Description

    Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.

    Data type

    text

    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.
    Description

    TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

    Data type

    text

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

    EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.

    Data type

    text

    No locally advanced inoperable or inflammatory breast cancer
    Description

    Nolocallyadvancedinoperableorinflammatorybreastcancer

    Data type

    text

    no bilateral invasive breast cancer.
    Description

    Nobilateralinvasivebreastcancer.

    Data type

    text

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

    Finalmarginsnegative

    Data type

    text

    No clinically detectable residual axillary disease.
    Description

    Noclinicallydetectableresidualaxillarydisease.

    Data type

    text

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

    Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.

    Data type

    text

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

    Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

    Data type

    text

    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.
    Description

    NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.

    Data type

    text

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

    Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

    Data type

    text

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

    Nopriorbilateraloophorectomyorovarianreduction.

    Data type

    text

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

    Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.

    Data type

    text

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

    Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

    Data type

    text

    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.
    Description

    Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.

    Data type

    text

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

    Noendocrinetherapyafterbreastcancerdiagnosis.

    Data type

    text

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

    NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.

    Data type

    text

    Has not received neoadjuvant or adjuvant chemotherapy.
    Description

    Noneoadjuvantoradjuvantchemotherapy.

    Data type

    text

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

    Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

    Data type

    text

    Accessible for follow-up.
    Description

    Accessibleforfollow-up.

    Data type

    text

    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.
    Description

    Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.

    Data type

    text

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

    AreallanswerstotheEligibilityChecklistYES?

    Data type

    text

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

    Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?

    Data type

    text

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

    DateInformedConsentFormsignedbypatient

    Data type

    text

    Date informed consent form signed by investigator
    Description

    DateInformedConsentFormsignedbyInvestigator

    Data type

    text

    Is protocol-required pathology material available
    Description

    SpecimenCollectedIBCSGStatus

    Data type

    text

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

    SpecimenCollectedIBCSGSpecify

    Data type

    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?
    Description

    HavebaselineQLCoreandmoduleformsbeencompleted?

    Data type

    text

    Other reason, specify (QL forms not completed)
    Description

    no,otherreason,specify(QLformsnotcompleted)

    Data type

    text

    Date baseline QL forms were completed
    Description

    DatebaselineQLformswerecompleted

    Data type

    text

    Tumor Laterality
    Description

    PrimaryTumorLateralityType

    Data type

    text

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

    RightBreastLymphNodeAssessmentStatus

    Data type

    text

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

    LeftBreastLymphNodeAssessmentStatus

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25229
    UMLS 2011AA ObjectClass
    C0205091
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Intended method of ovarian function suppression
    Description

    Intendedmethodofovarianfunctionsuppression

    Data type

    text

    Intended chemotherapy
    Description

    Intendedchemotherapy

    Data type

    text

    Intended endocrine agent
    Description

    Intendedendocrineagent

    Data type

    text

    Projected Treatment Begin Date
    Description

    TreatmentProjectedBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25631
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    Date of Most Extensive Primary Surgery (Left breast/side)
    Description

    PrimarySurgeryDate

    Data type

    date

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

    PrimarySurgeryDate

    Data type

    date

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

    PrimarySurgeryType

    Data type

    text

    Most Extensive Primary Surgery (Left breast/side)
    Description

    PrimarySurgeryType

    Data type

    text

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

    Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

    Data type

    text

    Specimen ID Number (Left breast/side)
    Description

    SpecimenIdentifierNumber

    Data type

    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)
    Description

    SpecimenIdentifierNumber

    Data type

    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
    Lab Facility Name
    Description

    SpecimenLabIdentifierName

    Data type

    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
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    Pathology Institute Code
    Description

    PathologyInstituteCode

    Data type

    text

    Full name of person randomizing at participating center
    Description

    Fullnameofpersonrandomizingatparticipatingcenter

    Data type

    text

    Fax Number
    Description

    PersonFaxNumber

    Data type

    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
    C25210
    UMLS 2011AA ValueDomain
    C0085205
    Phone number
    Description

    OrganizationPhoneNumber

    Data type

    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
    Description

    Fullnameofinvestigatorresponsibleforconfirmingeligibility

    Data type

    text

    Treating physician
    Description

    TreatingPhysicianName

    Data type

    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
    C25705
    UMLS 2011AA ObjectClass
    C1522326
    IBCSG Patient ID
    Description

    PatientInternationalBreastCancerStudyGroupIdentifierNumber

    Data type

    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
    C25530
    UMLS 2011AA Property
    C1512890
    Assigned Treatment Arm
    Description

    TreatmentArmIBCSGType

    Data type

    text

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

    ProtocolRandomizationDate

    Data type

    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
    Description

    NameofpersonwhoperfomedrandomizationatRandomizationCenter

    Data type

    text

    NCI Investigator Number Code
    Description

    NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText

    Data type

    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
    C19924
    UMLS 2011AA ObjectClass
    C1521895
    Investigator Signature
    Description

    InvestigatorSignatureText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Date
    Description

    InvestigatorSignatureDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173

    Similar models

    No Instruction available.

    1. StudyEvent: Confirmation of Registration Form (Form 26-A)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Ccrr Module For Registration Form (form 26 A)
    PatientStudyID,CoordinatingGroup
    Item
    Patient ID No.
    text
    PatientInitialsName
    Item
    Patient Initials
    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)
    PatientBirthDate
    Item
    Patient's Date of Birth
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus ValueDomain)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA 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
    Item
    Premenopausal
    text
    Code List
    Premenopausal
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Suitable for adding chemotherapy to the adjuvant systemic therapy
    text
    Code List
    Suitable for adding chemotherapy to the adjuvant systemic therapy
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Randomized within 12 weeks after definite surgery
    text
    Code List
    Randomized within 12 weeks after definite surgery
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    To be selected by subsequent randomization to the TEXT trial
    text
    Code List
    To be selected by subsequent randomization to the TEXT trial
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Tamoxifen
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    Code List
    Tamoxifen
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Exemestane
    text
    Code List
    Exemestane
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Histologically proven, resected breast cancer
    text
    Code List
    Histologically proven, resected breast cancer
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation
    text
    Code List
    Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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.
    text
    Code List
    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.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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.
    text
    Code List
    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.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Either axillary lymph node dissection OR negative axillary node biopsy and workup.
    text
    Code List
    Either axillary lymph node dissection OR negative axillary node biopsy and workup.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No locally advanced inoperable or inflammatory breast cancer
    text
    Code List
    No locally advanced inoperable or inflammatory breast cancer
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    no bilateral invasive breast cancer.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    no bilateral invasive breast cancer.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Final margins negative
    text
    Code List
    Final margins negative
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No clinically detectable residual axillary disease.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    No clinically detectable residual axillary disease.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
    text
    Code List
    No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No history of prior ipsilateral or contralateral invasive breast cancer.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    No history of prior ipsilateral or contralateral invasive breast cancer.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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.
    text
    Code List
    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.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No non-malignant systemic diseases that would prevent prolonged follow-up.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    No non-malignant systemic diseases that would prevent prolonged follow-up.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No prior bilateral oophorectomy or ovarian reduction.
    text
    Code List
    No prior bilateral oophorectomy or ovarian reduction.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No history of noncompliance to medical regimens and no considered potentially unreliable.
    text
    Code List
    No history of noncompliance to medical regimens and no considered potentially unreliable.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No endocrine therapy after breast cancer diagnosis.
    text
    Code List
    No endocrine therapy after breast cancer diagnosis.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
    text
    Code List
    No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Has not received neoadjuvant or adjuvant chemotherapy.
    text
    Code List
    Has not received neoadjuvant or adjuvant chemotherapy.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study.
    text
    Code List
    No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Accessible for follow-up.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Accessible for follow-up.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Are all answers to the Eligibility Checklist YES?
    text
    Code List
    Are all answers to the Eligibility Checklist YES?
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Has informed consent form been signed and dated by the patient and investigator?
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Has informed consent form been signed and dated by the patient and investigator?
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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
    Item
    Tumor Laterality
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    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)
    C0006141 (UMLS 2011AA ObjectClass)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    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)
    C0006141 (UMLS 2011AA ObjectClass)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    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)
    Item
    Intended method of ovarian function suppression
    text
    Code List
    Intended method of ovarian function suppression
    CL Item
    Triptorelin For 5 Years (triptorelin for 5 years)
    CL Item
    Surgical Oophorectomy (surgical oophorectomy)
    CL Item
    Ovarian Irradiation (ovarian irradiation)
    Item
    Intended chemotherapy
    text
    Code List
    Intended chemotherapy
    CL Item
    Not Containing Anthracycline Or Taxane (not containing anthracycline or taxane)
    CL Item
    Containing Anthracycline Or Taxane (containing anthracycline or taxane)
    Item
    Intended endocrine agent
    text
    Code List
    Intended endocrine agent
    CL Item
    Selected By Randomization In The Text Trial (selected by randomization in the TEXT trial)
    CL Item
    Tamoxifen, Chosen By Clinician/patient (Tamoxifen, chosen by clinician/patient)
    CL Item
    Exemestane, Chosen By Clinician/patient (Exemestane, chosen by clinician/patient)
    TreatmentProjectedBeginDate
    Item
    Projected Treatment Begin Date
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    PrimarySurgeryDate
    Item
    Date of Most Extensive Primary Surgery (Left breast/side)
    date
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass)
    C0543467 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    PrimarySurgeryDate
    Item
    Date of Most Extensive Primary Surgery (Left breast/side)
    date
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass)
    C0543467 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Most Extensive Primary Surgery (Left breast/side)
    text
    Code List
    Most Extensive Primary Surgery (Left breast/side)
    CL Item
    Mastectomy, Nos (Mastectomy)
    CL Item
    Less than mastectomy (Less than mastectomy)
    Item
    Most Extensive Primary Surgery (Left breast/side)
    text
    Code List
    Most Extensive Primary Surgery (Left breast/side)
    CL Item
    Mastectomy, Nos (Mastectomy)
    CL Item
    Less than mastectomy (Less than mastectomy)
    Item
    Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
    text
    Code List
    Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    SpecimenIdentifierNumber
    Item
    Specimen ID Number (Left 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)
    SpecimenIdentifierNumber
    Item
    Specimen ID Number (Left 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)
    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)
    C0370003 (UMLS 2011AA ObjectClass)
    PathologyInstituteCode
    Item
    Pathology Institute Code
    text
    Fullnameofpersonrandomizingatparticipatingcenter
    Item
    Full name of person randomizing at participating center
    text
    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)
    C0085205 (UMLS 2011AA ValueDomain)
    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)
    C1522326 (UMLS 2011AA ObjectClass)
    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)
    C1512890 (UMLS 2011AA Property)
    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
    Chemotherapy Plus Ofs Plus Tamoxifen Or Exemestane For 5 Years (Chemotherapy plus OFS plus Tamoxifen or Exemestane for 5 years)
    CL Item
    Ofs Plus Tamoxifen Or Exemestane For 5 Years (OFS plus Tamoxifen or Exemestane 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)
    C1521895 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureText
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureDate
    Item
    Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)

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