ID

8931

Beschreibung

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

Stichworte

Versionen (2)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00066807 Registration - Confirmation of Registration Form (Form 26-A) - 2167967v3.0

Englisch

No Instruction available.

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

Ccrr Module For Registration Form (form 26 A)

Patient ID No.
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

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

Birth Date

Datentyp

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
Beschreibung

ParticipatingCenter/Affiliate

Datentyp

text

Center Code
Beschreibung

ParticipatingGroupCode

Datentyp

text

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

PMDCode

Datentyp

text

Premenopausal
Beschreibung

Premenopausal

Datentyp

boolean

Suitable for adding chemotherapy to the adjuvant systemic therapy
Beschreibung

Suitableforaddingchemotherapytotheadjuvantsystemictherapy

Datentyp

boolean

Randomized within 12 weeks after definite surgery
Beschreibung

Randomizedwithin12weeksafterdefinitesurgery

Datentyp

boolean

To be selected by subsequent randomization to the TEXT trial
Beschreibung

TobeselectedbysubsequentrandomizationtotheTEXTtrial

Datentyp

boolean

Tamoxifen
Beschreibung

Tamoxifen

Datentyp

boolean

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

Exemestane

Datentyp

boolean

Histologically proven, resected breast cancer
Beschreibung

Histologicallyproven,resectedbreastcancer

Datentyp

boolean

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

Estrogenand/orprogesteronereceptorPostitivetumorwhichisdefinedas>or=10%oftumorcellspositivebyimmunohistochemicalevaluation

Datentyp

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.
Beschreibung

Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.

Datentyp

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.
Beschreibung

TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

Datentyp

boolean

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

EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.

Datentyp

boolean

No locally advanced inoperable or inflammatory breast cancer
Beschreibung

Nolocallyadvancedinoperableorinflammatorybreastcancer

Datentyp

boolean

no bilateral invasive breast cancer.
Beschreibung

Nobilateralinvasivebreastcancer.

Datentyp

boolean

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

Finalmarginsnegative

Datentyp

boolean

No clinically detectable residual axillary disease.
Beschreibung

Noclinicallydetectableresidualaxillarydisease.

Datentyp

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.
Beschreibung

Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.

Datentyp

boolean

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

Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

Datentyp

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.
Beschreibung

NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.

Datentyp

boolean

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

Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

Datentyp

boolean

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

Nopriorbilateraloophorectomyorovarianreduction.

Datentyp

boolean

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

Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.

Datentyp

boolean

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

Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

Datentyp

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.
Beschreibung

Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.

Datentyp

boolean

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

Noendocrinetherapyafterbreastcancerdiagnosis.

Datentyp

boolean

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

NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.

Datentyp

boolean

Has not received neoadjuvant or adjuvant chemotherapy.
Beschreibung

Noneoadjuvantoradjuvantchemotherapy.

Datentyp

boolean

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

Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

Datentyp

boolean

Accessible for follow-up.
Beschreibung

Accessibleforfollow-up.

Datentyp

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.
Beschreibung

Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.

Datentyp

boolean

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

AreallanswerstotheEligibilityChecklistYES?

Datentyp

boolean

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

Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?

Datentyp

boolean

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

DateInformedConsentFormsignedbypatient

Datentyp

text

Date informed consent form signed by investigator
Beschreibung

DateInformedConsentFormsignedbyInvestigator

Datentyp

text

Is protocol-required pathology material available
Beschreibung

SpecimenCollectedIBCSGStatus

Datentyp

text

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

SpecimenCollectedIBCSGSpecify

Datentyp

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?
Beschreibung

HavebaselineQLCoreandmoduleformsbeencompleted?

Datentyp

text

Other reason, specify (QL forms not completed)
Beschreibung

no,otherreason,specify(QLformsnotcompleted)

Datentyp

text

Date baseline QL forms were completed
Beschreibung

DatebaselineQLformswerecompleted

Datentyp

text

Tumor Laterality
Beschreibung

PrimaryTumorLateralityType

Datentyp

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
Beschreibung

RightBreastLymphNodeAssessmentStatus

Datentyp

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
Beschreibung

LeftBreastLymphNodeAssessmentStatus

Datentyp

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
Beschreibung

Intendedmethodofovarianfunctionsuppression

Datentyp

text

Intended chemotherapy
Beschreibung

Intendedchemotherapy

Datentyp

text

Intended endocrine agent
Beschreibung

Intendedendocrineagent

Datentyp

text

Projected Treatment Begin Date
Beschreibung

Treatment Begin Date

Datentyp

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)
Beschreibung

PrimarySurgeryDate

Datentyp

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)
Beschreibung

PrimarySurgeryDate

Datentyp

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)
Beschreibung

PrimarySurgeryType

Datentyp

text

Most Extensive Primary Surgery (Left breast/side)
Beschreibung

PrimarySurgeryType

Datentyp

text

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

Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

Datentyp

boolean

Specimen ID Number (Left breast/side)
Beschreibung

SpecimenIdentifierNumber

Datentyp

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)
Beschreibung

SpecimenIdentifierNumber

Datentyp

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
Beschreibung

SpecimenLabIdentifierName

Datentyp

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
Beschreibung

PathologyInstituteCode

Datentyp

text

Full name of person randomizing at participating center
Beschreibung

Fullnameofpersonrandomizingatparticipatingcenter

Datentyp

text

Fax Number
Beschreibung

PersonFaxNumber

Datentyp

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
Beschreibung

OrganizationPhoneNumber

Datentyp

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
Beschreibung

Fullnameofinvestigatorresponsibleforconfirmingeligibility

Datentyp

text

Treating physician
Beschreibung

TreatingPhysicianName

Datentyp

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
Beschreibung

PatientInternationalBreastCancerStudyGroupIdentifierNumber

Datentyp

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
Beschreibung

TreatmentArmIBCSGType

Datentyp

text

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

ProtocolRandomizationDate

Datentyp

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
Beschreibung

NameofpersonwhoperfomedrandomizationatRandomizationCenter

Datentyp

text

NCI Investigator Number Code
Beschreibung

NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText

Datentyp

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
Beschreibung

Investigator Signature

Datentyp

text

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

Investigator Signature Date

Datentyp

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
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Confirmation of Registration Form (Form 26-A)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
CL.32
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
CL.33
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)
CL.34
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)
CL.35
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)
CL.36
Code List
Left Breast/Side
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
Item
Intended method of ovarian function suppression
text
CL.37
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
CL.38
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
CL.39
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
CL.41
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
CL.41
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)
CL.43
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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