ID

8931

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

Lien

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

Mots-clés

  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le

9 janvier 2015

DOI

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Licence

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

    Type de données

    text

    Patient Initials
    Description

    Patient Initials

    Type de données

    text

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

    Birth Date

    Type de données

    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
    Description

    ParticipatingCenter/Affiliate

    Type de données

    text

    Center Code
    Description

    ParticipatingGroupCode

    Type de données

    text

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

    PMDCode

    Type de données

    text

    Premenopausal
    Description

    Premenopausal

    Type de données

    boolean

    Suitable for adding chemotherapy to the adjuvant systemic therapy
    Description

    Suitableforaddingchemotherapytotheadjuvantsystemictherapy

    Type de données

    boolean

    Randomized within 12 weeks after definite surgery
    Description

    Randomizedwithin12weeksafterdefinitesurgery

    Type de données

    boolean

    To be selected by subsequent randomization to the TEXT trial
    Description

    TobeselectedbysubsequentrandomizationtotheTEXTtrial

    Type de données

    boolean

    Tamoxifen
    Description

    Tamoxifen

    Type de données

    boolean

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

    Exemestane

    Type de données

    boolean

    Histologically proven, resected breast cancer
    Description

    Histologicallyproven,resectedbreastcancer

    Type de données

    boolean

    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

    Type de données

    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.
    Description

    Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.

    Type de données

    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.
    Description

    TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

    Type de données

    boolean

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

    EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.

    Type de données

    boolean

    No locally advanced inoperable or inflammatory breast cancer
    Description

    Nolocallyadvancedinoperableorinflammatorybreastcancer

    Type de données

    boolean

    no bilateral invasive breast cancer.
    Description

    Nobilateralinvasivebreastcancer.

    Type de données

    boolean

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

    Finalmarginsnegative

    Type de données

    boolean

    No clinically detectable residual axillary disease.
    Description

    Noclinicallydetectableresidualaxillarydisease.

    Type de données

    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.
    Description

    Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.

    Type de données

    boolean

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

    Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

    Type de données

    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.
    Description

    NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.

    Type de données

    boolean

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

    Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

    Type de données

    boolean

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

    Nopriorbilateraloophorectomyorovarianreduction.

    Type de données

    boolean

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

    Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.

    Type de données

    boolean

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

    Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

    Type de données

    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.
    Description

    Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.

    Type de données

    boolean

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

    Noendocrinetherapyafterbreastcancerdiagnosis.

    Type de données

    boolean

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

    NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.

    Type de données

    boolean

    Has not received neoadjuvant or adjuvant chemotherapy.
    Description

    Noneoadjuvantoradjuvantchemotherapy.

    Type de données

    boolean

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

    Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

    Type de données

    boolean

    Accessible for follow-up.
    Description

    Accessibleforfollow-up.

    Type de données

    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.
    Description

    Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.

    Type de données

    boolean

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

    AreallanswerstotheEligibilityChecklistYES?

    Type de données

    boolean

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

    Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?

    Type de données

    boolean

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

    DateInformedConsentFormsignedbypatient

    Type de données

    text

    Date informed consent form signed by investigator
    Description

    DateInformedConsentFormsignedbyInvestigator

    Type de données

    text

    Is protocol-required pathology material available
    Description

    SpecimenCollectedIBCSGStatus

    Type de données

    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

    Type de données

    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?

    Type de données

    text

    Other reason, specify (QL forms not completed)
    Description

    no,otherreason,specify(QLformsnotcompleted)

    Type de données

    text

    Date baseline QL forms were completed
    Description

    DatebaselineQLformswerecompleted

    Type de données

    text

    Tumor Laterality
    Description

    PrimaryTumorLateralityType

    Type de données

    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
    Description

    RightBreastLymphNodeAssessmentStatus

    Type de données

    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
    Description

    LeftBreastLymphNodeAssessmentStatus

    Type de données

    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
    Intended method of ovarian function suppression
    Description

    Intendedmethodofovarianfunctionsuppression

    Type de données

    text

    Intended chemotherapy
    Description

    Intendedchemotherapy

    Type de données

    text

    Intended endocrine agent
    Description

    Intendedendocrineagent

    Type de données

    text

    Projected Treatment Begin Date
    Description

    Treatment Begin Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Date of Most Extensive Primary Surgery (Left breast/side)
    Description

    PrimarySurgeryDate

    Type de données

    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)
    Description

    PrimarySurgeryDate

    Type de données

    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 (Left breast/side)
    Description

    PrimarySurgeryType

    Type de données

    text

    Most Extensive Primary Surgery (Left breast/side)
    Description

    PrimarySurgeryType

    Type de données

    text

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

    Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

    Type de données

    boolean

    Specimen ID Number (Left breast/side)
    Description

    SpecimenIdentifierNumber

    Type de données

    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

    Type de données

    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

    Type de données

    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
    Description

    PathologyInstituteCode

    Type de données

    text

    Full name of person randomizing at participating center
    Description

    Fullnameofpersonrandomizingatparticipatingcenter

    Type de données

    text

    Fax Number
    Description

    PersonFaxNumber

    Type de données

    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
    Description

    OrganizationPhoneNumber

    Type de données

    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

    Type de données

    text

    Treating physician
    Description

    TreatingPhysicianName

    Type de données

    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
    Description

    PatientInternationalBreastCancerStudyGroupIdentifierNumber

    Type de données

    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
    Description

    TreatmentArmIBCSGType

    Type de données

    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

    Type de données

    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

    Type de données

    text

    NCI Investigator Number Code
    Description

    NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText

    Type de données

    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
    Description

    Investigator Signature

    Type de données

    text

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

    Investigator Signature Date

    Type de données

    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 26-A)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Ccrr Module For Registration Form (form 26 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
    Suitableforaddingchemotherapytotheadjuvantsystemictherapy
    Item
    Suitable for adding chemotherapy to the adjuvant systemic therapy
    boolean
    Randomizedwithin12weeksafterdefinitesurgery
    Item
    Randomized within 12 weeks after definite surgery
    boolean
    TobeselectedbysubsequentrandomizationtotheTEXTtrial
    Item
    To be selected by subsequent randomization to the TEXT trial
    boolean
    Tamoxifen
    Item
    Tamoxifen
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    Exemestane
    Item
    Exemestane
    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
    Has not received 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
    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)
    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)
    Treatment Begin Date
    Item
    Projected Treatment Begin Date
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (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)
    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 (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)
    Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
    Item
    Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
    boolean
    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-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    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-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
    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-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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