ID
9024
Beschrijving
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
Link
Trefwoorden
Versies (2)
- 27-08-12 27-08-12 -
- 09-01-15 09-01-15 - Martin Dugas
Geüploaded op
9 januari 2015
DOI
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Licentie
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)
Beschrijving
Eligibility Checklist
Beschrijving
Randomizedwithin12weeksafterdefinitivesurgery.
Datatype
boolean
Beschrijving
Premenopausal[estrodiol(E2)inpremenopausalrange]followingsurgery.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Randomizedaftercompletingchemotherapyandwithin6monthsofthefinaldoseofchemotherapyassoonaspremenopausalstatusisconfirmed.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Premenopausal[estrodiol(E2)inpremenopausalrange]between2weeksand6monthsaftercompletingchemotherapy.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Histologicallyproven,resectedbreastcancer.
Datatype
boolean
Beschrijving
Estrogenand/orprogesteronereceptorPOSITIVEtumorwhichisdefinedas.Or=10%ofthetumorcellspositivebyimmunohistochemicalevaluation.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.Patientswhoreceivedneoadjuvanttherapymusthavehadop
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Totalmastectomy(withorwithoutradiotherapyplanned)ORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
EitheraxillarylymphnodedissectionORnegativeaxillarysentinelnodebiopsyandworkup.PatientswithH&Epositiveaxillarynodesrequireaxillarydissection,exceptforpatientswithmicroscopicallypositive(pN1mi:micrometastasis<2mm)axillary
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Eligibility Checklist
Beschrijving
Nolocallyadvancedinoperableorinflammatorybreastcancer.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nobilateralinvasivebreastcancer.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Finalmarginsnegative
Datatype
boolean
Beschrijving
Noclinicallydetectableresidualaxillarydisease.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nosupraclavicularnodeinvolvementorevidenceofdistantmetastaticdisease.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nopriorbilateraloophorectomyorovarianradiation,andnoplanforoophorectomywithinfiveyears
Datatype
text
Beschrijving
(exceptifrandomizedtoOFS).
Datatype
boolean
Beschrijving
Nohistoryofnoncompliancetomedicalregimensandnotconsideredpotentiallyunreliable.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nomorethansixmonthsofendocrinetreatment(adjuvantandneoadjuvant)afterbreastcancerdiagnosis.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
NoTamoxifen,otherSERM(e.g.Raloxifene),orHRTwithin1yearpriortodiagnosis.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
HasnottakenGnRHanalogueforbreastcancertreatment.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Nopsychiatric,addictiveorotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Accessibleforfollow-up.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
ArealltheanswerstotheEligibilityChecklistYES?
Datatype
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
PatientConsentSignedIndicator
Datatype
boolean
Beschrijving
DateInformedConsentFormsignedbypatient
Datatype
text
Beschrijving
DateInformedConsentFormsignedbyInvestigator
Datatype
text
Beschrijving
SpecimenCollectedIBCSGStatus
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property
- C25452
- NCI Thesaurus ValueDomain
- C25688
- UMLS 2011AA ValueDomain
- C0449438
Beschrijving
SpecimenCollectedIBCSGSpecify
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property
- C25452
Beschrijving
HavebaselineQLCoreandmoduleformsbeencompleted?
Datatype
text
Beschrijving
no,otherreason,specify(QLformsnotcompleted)
Datatype
text
Beschrijving
DatebaselineQLformswerecompleted
Datatype
text
Beschrijving
Stratification Factors
Beschrijving
PriorChemotherapyAdministeredIBCSGInd-2
Datatype
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
Beschrijving
PrimaryTumorLateralityType
Datatype
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
Beschrijving
RightBreastLymphNodeAssessmentStatus
Datatype
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
Beschrijving
LeftBreastLymphNodeAssessmentStatus
Datatype
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
Beschrijving
IntendedmethodofovarianfunctionsuppressionifpatientisrandomizedtoOFS:
Datatype
text
Beschrijving
ChemotherapyLastAdministeredDate
Datatype
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
Beschrijving
PrimarySurgeryDate
Datatype
date
Beschrijving
PrimarySurgeryDate
Datatype
date
Beschrijving
PrimarySurgeryType
Datatype
text
Beschrijving
PrimarySurgeryType
Datatype
text
Beschrijving
Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
Datatype
boolean
Beschrijving
SpecimenID
Datatype
float
Beschrijving
SpecimenID
Datatype
float
Beschrijving
SpecimenLabIdentifierName
Datatype
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
Beschrijving
PathologyInstituteCode
Datatype
text
Beschrijving
RandomizationPersonName
Datatype
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
Beschrijving
PersonFaxNumber
Datatype
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
Beschrijving
OrganizationPhoneNumber
Datatype
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
Beschrijving
Fullnameofinvestigatorresponsibleforconfirmingeligibility
Datatype
text
Beschrijving
TreatingPhysicianName
Datatype
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
Beschrijving
PatientInternationalBreastCancerStudyGroupIdentifierNumber
Datatype
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
Beschrijving
TreatmentArmIBCSGType
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
- NCI Thesaurus Property
- C32141
- UMLS 2011AA Property
- C1140618
- NCI Thesaurus ObjectClass
- C15368
Beschrijving
ProtocolRandomizationDate
Datatype
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
Beschrijving
NameofpersonwhoperformedrandomizationatRandomizationCenter
Datatype
text
Beschrijving
NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText
Datatype
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
Beschrijving
Investigator Signature
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS CUI-1
- C2346576
- NCI Thesaurus Property
- C25678
- NCI Thesaurus ObjectClass
- C17089
Beschrijving
Investigator Signature Date
Datatype
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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