ID
9024
Descrizione
Confirmation of Registration Form (Form 24-A) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA065B-0F5E-629F-E034-0003BA12F5E7
collegamento
Keywords
versioni (2)
- 27/08/12 27/08/12 -
- 09/01/15 09/01/15 - Martin Dugas
Caricato su
9 gennaio 2015
DOI
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Licenza
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Registration - Confirmation of Registration Form (Form 24-A) - 2072688v3.0
CONFIRMATION OF REGISTRATIN FORM (Form 24-A)
- StudyEvent: Confirmation of Registration Form (Form 24-A)
Descrizione
Eligibility Checklist
Descrizione
Randomizedwithin12weeksafterdefinitivesurgery.
Tipo di dati
boolean
Descrizione
Premenopausal[estrodiol(E2)inpremenopausalrange]followingsurgery.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Randomizedaftercompletingchemotherapyandwithin6monthsofthefinaldoseofchemotherapyassoonaspremenopausalstatusisconfirmed.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Premenopausal[estrodiol(E2)inpremenopausalrange]between2weeksand6monthsaftercompletingchemotherapy.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Histologicallyproven,resectedbreastcancer.
Tipo di dati
boolean
Descrizione
Estrogenand/orprogesteronereceptorPOSITIVEtumorwhichisdefinedas.Or=10%ofthetumorcellspositivebyimmunohistochemicalevaluation.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.Patientswhoreceivedneoadjuvanttherapymusthavehadop
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Totalmastectomy(withorwithoutradiotherapyplanned)ORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
EitheraxillarylymphnodedissectionORnegativeaxillarysentinelnodebiopsyandworkup.PatientswithH&Epositiveaxillarynodesrequireaxillarydissection,exceptforpatientswithmicroscopicallypositive(pN1mi:micrometastasis<2mm)axillary
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Eligibility Checklist
Descrizione
Nolocallyadvancedinoperableorinflammatorybreastcancer.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nobilateralinvasivebreastcancer.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Finalmarginsnegative
Tipo di dati
boolean
Descrizione
Noclinicallydetectableresidualaxillarydisease.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nosupraclavicularnodeinvolvementorevidenceofdistantmetastaticdisease.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nopriorbilateraloophorectomyorovarianradiation,andnoplanforoophorectomywithinfiveyears
Tipo di dati
text
Descrizione
(exceptifrandomizedtoOFS).
Tipo di dati
boolean
Descrizione
Nohistoryofnoncompliancetomedicalregimensandnotconsideredpotentiallyunreliable.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nomorethansixmonthsofendocrinetreatment(adjuvantandneoadjuvant)afterbreastcancerdiagnosis.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
NoTamoxifen,otherSERM(e.g.Raloxifene),orHRTwithin1yearpriortodiagnosis.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
HasnottakenGnRHanalogueforbreastcancertreatment.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Nopsychiatric,addictiveorotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Accessibleforfollow-up.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
ArealltheanswerstotheEligibilityChecklistYES?
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descrizione
PatientConsentSignedIndicator
Tipo di dati
boolean
Descrizione
DateInformedConsentFormsignedbypatient
Tipo di dati
text
Descrizione
DateInformedConsentFormsignedbyInvestigator
Tipo di dati
text
Descrizione
SpecimenCollectedIBCSGStatus
Tipo di dati
text
Alias
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property
- C25452
- NCI Thesaurus ValueDomain
- C25688
- UMLS 2011AA ValueDomain
- C0449438
Descrizione
SpecimenCollectedIBCSGSpecify
Tipo di dati
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property
- C25452
Descrizione
HavebaselineQLCoreandmoduleformsbeencompleted?
Tipo di dati
text
Descrizione
no,otherreason,specify(QLformsnotcompleted)
Tipo di dati
text
Descrizione
DatebaselineQLformswerecompleted
Tipo di dati
text
Descrizione
Stratification Factors
Descrizione
PriorChemotherapyAdministeredIBCSGInd-2
Tipo di dati
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
- NCI Thesaurus ObjectClass
- C15632
- UMLS 2011AA ObjectClass
- C0392920
- NCI Thesaurus ObjectClass-2
- C25629
- UMLS 2011AA ObjectClass-2
- C0332152
- NCI Thesaurus Property
- C25382
- UMLS 2011AA Property
- C1521801
Descrizione
PrimaryTumorLateralityType
Tipo di dati
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
Descrizione
RightBreastLymphNodeAssessmentStatus
Tipo di dati
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
Descrizione
LeftBreastLymphNodeAssessmentStatus
Tipo di dati
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
Descrizione
IntendedmethodofovarianfunctionsuppressionifpatientisrandomizedtoOFS:
Tipo di dati
text
Descrizione
ChemotherapyLastAdministeredDate
Tipo di dati
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ObjectClass
- C15632
- UMLS 2011AA ObjectClass
- C0392920
- NCI Thesaurus Property
- C25551
- UMLS 2011AA Property
- C1517741
- NCI Thesaurus Property-2
- C25382
- UMLS 2011AA Property-2
- C1521801
Descrizione
PrimarySurgeryDate
Tipo di dati
date
Descrizione
PrimarySurgeryDate
Tipo di dati
date
Descrizione
PrimarySurgeryType
Tipo di dati
text
Descrizione
PrimarySurgeryType
Tipo di dati
text
Descrizione
Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
Tipo di dati
boolean
Descrizione
SpecimenID
Tipo di dati
float
Descrizione
SpecimenID
Tipo di dati
float
Descrizione
SpecimenLabIdentifierName
Tipo di dati
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
Descrizione
PathologyInstituteCode
Tipo di dati
text
Descrizione
RandomizationPersonName
Tipo di dati
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS 2011AA ValueDomain
- C1547383
- NCI Thesaurus ObjectClass
- C25190
- UMLS 2011AA ObjectClass
- C0027361
- NCI Thesaurus Property
- C25364
- UMLS 2011AA Property
- C0600091
- NCI Thesaurus ObjectClass-2
- C25196
- UMLS 2011AA ObjectClass-2
- C0034656
Descrizione
PersonFaxNumber
Tipo di dati
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
Descrizione
OrganizationPhoneNumber
Tipo di dati
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
Descrizione
Fullnameofinvestigatorresponsibleforconfirmingeligibility
Tipo di dati
text
Descrizione
TreatingPhysicianName
Tipo di dati
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
Descrizione
PatientInternationalBreastCancerStudyGroupIdentifierNumber
Tipo di dati
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
Descrizione
TreatmentArmIBCSGType
Tipo di dati
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
- NCI Thesaurus Property
- C32141
- UMLS 2011AA Property
- C1140618
- NCI Thesaurus ObjectClass
- C15368
Descrizione
ProtocolRandomizationDate
Tipo di dati
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
Descrizione
NameofpersonwhoperformedrandomizationatRandomizationCenter
Tipo di dati
text
Descrizione
NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText
Tipo di dati
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
Descrizione
Investigator Signature
Tipo di dati
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS CUI-1
- C2346576
- NCI Thesaurus Property
- C25678
- NCI Thesaurus ObjectClass
- C17089
Descrizione
Investigator Signature Date
Tipo di dati
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
CONFIRMATION OF REGISTRATIN FORM (Form 24-A)
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C2986440 (UMLS CUI-1)
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C1512698 (UMLS 2011AA ValueDomain)
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C1512698 (UMLS 2011AA ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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C25452 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
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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)
C0238767 (UMLS 2011AA)
C0205091 (UMLS 2011AA)
C0205090 (UMLS 2011AA)
C0205090 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
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C0024204 (UMLS 2011AA ObjectClass-3)
C20989 (NCI Thesaurus Property)
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C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
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)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
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C1521801 (UMLS 2011AA Property-2)
C0024881 (UMLS 2011AA)
C0024881 (UMLS 2011AA)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
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C0022877 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C1547383 (UMLS 2011AA ValueDomain)
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C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
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C25196 (NCI Thesaurus ObjectClass-2)
C0034656 (UMLS 2011AA ObjectClass-2)
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)
C0237753 (UMLS 2011AA ValueDomain)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C19711 (NCI Thesaurus ObjectClass)
C1522486 (UMLS 2011AA ObjectClass)
C1547383 (UMLS 2011AA ValueDomain)
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C0600091 (UMLS 2011AA Property)
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C0031831 (UMLS 2011AA ObjectClass)
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C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
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C0034656 (UMLS 2011AA Property)
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C1513882 (UMLS 2011AA ObjectClass)
C19924 (NCI Thesaurus ObjectClass-2)
C1521895 (UMLS 2011AA ObjectClass-2)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)