ID
9024
Descripción
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
Palabras clave
Versiones (2)
- 27/8/12 27/8/12 -
- 9/1/15 9/1/15 - Martin Dugas
Subido en
9 de enero de 2015
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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)
Descripción
Eligibility Checklist
Descripción
Randomizedwithin12weeksafterdefinitivesurgery.
Tipo de datos
boolean
Descripción
Premenopausal[estrodiol(E2)inpremenopausalrange]followingsurgery.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Randomizedaftercompletingchemotherapyandwithin6monthsofthefinaldoseofchemotherapyassoonaspremenopausalstatusisconfirmed.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Premenopausal[estrodiol(E2)inpremenopausalrange]between2weeksand6monthsaftercompletingchemotherapy.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Histologicallyproven,resectedbreastcancer.
Tipo de datos
boolean
Descripción
Estrogenand/orprogesteronereceptorPOSITIVEtumorwhichisdefinedas.Or=10%ofthetumorcellspositivebyimmunohistochemicalevaluation.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.Patientswhoreceivedneoadjuvanttherapymusthavehadop
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Totalmastectomy(withorwithoutradiotherapyplanned)ORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
EitheraxillarylymphnodedissectionORnegativeaxillarysentinelnodebiopsyandworkup.PatientswithH&Epositiveaxillarynodesrequireaxillarydissection,exceptforpatientswithmicroscopicallypositive(pN1mi:micrometastasis<2mm)axillary
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Eligibility Checklist
Descripción
Nolocallyadvancedinoperableorinflammatorybreastcancer.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nobilateralinvasivebreastcancer.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Finalmarginsnegative
Tipo de datos
boolean
Descripción
Noclinicallydetectableresidualaxillarydisease.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nosupraclavicularnodeinvolvementorevidenceofdistantmetastaticdisease.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nopriorbilateraloophorectomyorovarianradiation,andnoplanforoophorectomywithinfiveyears
Tipo de datos
text
Descripción
(exceptifrandomizedtoOFS).
Tipo de datos
boolean
Descripción
Nohistoryofnoncompliancetomedicalregimensandnotconsideredpotentiallyunreliable.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nomorethansixmonthsofendocrinetreatment(adjuvantandneoadjuvant)afterbreastcancerdiagnosis.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
NoTamoxifen,otherSERM(e.g.Raloxifene),orHRTwithin1yearpriortodiagnosis.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
HasnottakenGnRHanalogueforbreastcancertreatment.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Nopsychiatric,addictiveorotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Accessibleforfollow-up.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
ArealltheanswerstotheEligibilityChecklistYES?
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
PatientConsentSignedIndicator
Tipo de datos
boolean
Descripción
DateInformedConsentFormsignedbypatient
Tipo de datos
text
Descripción
DateInformedConsentFormsignedbyInvestigator
Tipo de datos
text
Descripción
SpecimenCollectedIBCSGStatus
Tipo de datos
text
Alias
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property
- C25452
- NCI Thesaurus ValueDomain
- C25688
- UMLS 2011AA ValueDomain
- C0449438
Descripción
SpecimenCollectedIBCSGSpecify
Tipo de datos
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property
- C25452
Descripción
HavebaselineQLCoreandmoduleformsbeencompleted?
Tipo de datos
text
Descripción
no,otherreason,specify(QLformsnotcompleted)
Tipo de datos
text
Descripción
DatebaselineQLformswerecompleted
Tipo de datos
text
Descripción
Stratification Factors
Descripción
PriorChemotherapyAdministeredIBCSGInd-2
Tipo de datos
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
Descripción
PrimaryTumorLateralityType
Tipo de datos
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
Descripción
RightBreastLymphNodeAssessmentStatus
Tipo de datos
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
Descripción
LeftBreastLymphNodeAssessmentStatus
Tipo de datos
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
Descripción
IntendedmethodofovarianfunctionsuppressionifpatientisrandomizedtoOFS:
Tipo de datos
text
Descripción
ChemotherapyLastAdministeredDate
Tipo de datos
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
Descripción
PrimarySurgeryDate
Tipo de datos
date
Descripción
PrimarySurgeryDate
Tipo de datos
date
Descripción
PrimarySurgeryType
Tipo de datos
text
Descripción
PrimarySurgeryType
Tipo de datos
text
Descripción
Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
Tipo de datos
boolean
Descripción
SpecimenID
Tipo de datos
float
Descripción
SpecimenID
Tipo de datos
float
Descripción
SpecimenLabIdentifierName
Tipo de datos
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
Descripción
PathologyInstituteCode
Tipo de datos
text
Descripción
RandomizationPersonName
Tipo de datos
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
Descripción
PersonFaxNumber
Tipo de datos
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
Descripción
OrganizationPhoneNumber
Tipo de datos
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
Descripción
Fullnameofinvestigatorresponsibleforconfirmingeligibility
Tipo de datos
text
Descripción
TreatingPhysicianName
Tipo de datos
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
Descripción
PatientInternationalBreastCancerStudyGroupIdentifierNumber
Tipo de datos
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
Descripción
TreatmentArmIBCSGType
Tipo de datos
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
- NCI Thesaurus Property
- C32141
- UMLS 2011AA Property
- C1140618
- NCI Thesaurus ObjectClass
- C15368
Descripción
ProtocolRandomizationDate
Tipo de datos
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
Descripción
NameofpersonwhoperformedrandomizationatRandomizationCenter
Tipo de datos
text
Descripción
NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText
Tipo de datos
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
Descripción
Investigator Signature
Tipo de datos
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS CUI-1
- C2346576
- NCI Thesaurus Property
- C25678
- NCI Thesaurus ObjectClass
- C17089
Descripción
Investigator Signature Date
Tipo de datos
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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