ID
9024
Description
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
Lien
Mots-clés
Versions (2)
- 27/08/2012 27/08/2012 -
- 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 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)
Description
Eligibility Checklist
Description
Randomizedwithin12weeksafterdefinitivesurgery.
Type de données
boolean
Description
Premenopausal[estrodiol(E2)inpremenopausalrange]followingsurgery.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Randomizedaftercompletingchemotherapyandwithin6monthsofthefinaldoseofchemotherapyassoonaspremenopausalstatusisconfirmed.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Premenopausal[estrodiol(E2)inpremenopausalrange]between2weeksand6monthsaftercompletingchemotherapy.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Histologicallyproven,resectedbreastcancer.
Type de données
boolean
Description
Estrogenand/orprogesteronereceptorPOSITIVEtumorwhichisdefinedas.Or=10%ofthetumorcellspositivebyimmunohistochemicalevaluation.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.Patientswhoreceivedneoadjuvanttherapymusthavehadop
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Totalmastectomy(withorwithoutradiotherapyplanned)ORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
EitheraxillarylymphnodedissectionORnegativeaxillarysentinelnodebiopsyandworkup.PatientswithH&Epositiveaxillarynodesrequireaxillarydissection,exceptforpatientswithmicroscopicallypositive(pN1mi:micrometastasis<2mm)axillary
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Eligibility Checklist
Description
Nolocallyadvancedinoperableorinflammatorybreastcancer.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nobilateralinvasivebreastcancer.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Finalmarginsnegative
Type de données
boolean
Description
Noclinicallydetectableresidualaxillarydisease.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nosupraclavicularnodeinvolvementorevidenceofdistantmetastaticdisease.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nopriorbilateraloophorectomyorovarianradiation,andnoplanforoophorectomywithinfiveyears
Type de données
text
Description
(exceptifrandomizedtoOFS).
Type de données
boolean
Description
Nohistoryofnoncompliancetomedicalregimensandnotconsideredpotentiallyunreliable.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nomorethansixmonthsofendocrinetreatment(adjuvantandneoadjuvant)afterbreastcancerdiagnosis.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
NoTamoxifen,otherSERM(e.g.Raloxifene),orHRTwithin1yearpriortodiagnosis.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
HasnottakenGnRHanalogueforbreastcancertreatment.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Nopsychiatric,addictiveorotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Accessibleforfollow-up.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
ArealltheanswerstotheEligibilityChecklistYES?
Type de données
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
PatientConsentSignedIndicator
Type de données
boolean
Description
DateInformedConsentFormsignedbypatient
Type de données
text
Description
DateInformedConsentFormsignedbyInvestigator
Type de données
text
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
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
Description
HavebaselineQLCoreandmoduleformsbeencompleted?
Type de données
text
Description
no,otherreason,specify(QLformsnotcompleted)
Type de données
text
Description
DatebaselineQLformswerecompleted
Type de données
text
Description
Stratification Factors
Description
PriorChemotherapyAdministeredIBCSGInd-2
Type de données
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
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
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
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
Description
IntendedmethodofovarianfunctionsuppressionifpatientisrandomizedtoOFS:
Type de données
text
Description
ChemotherapyLastAdministeredDate
Type de données
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
Description
PrimarySurgeryDate
Type de données
date
Description
PrimarySurgeryDate
Type de données
date
Description
PrimarySurgeryType
Type de données
text
Description
PrimarySurgeryType
Type de données
text
Description
Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
Type de données
boolean
Description
SpecimenID
Type de données
float
Description
SpecimenID
Type de données
float
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
Description
PathologyInstituteCode
Type de données
text
Description
RandomizationPersonName
Type de données
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
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
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
Description
Fullnameofinvestigatorresponsibleforconfirmingeligibility
Type de données
text
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
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
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
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
Description
NameofpersonwhoperformedrandomizationatRandomizationCenter
Type de données
text
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
Description
Investigator Signature
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS CUI-1
- C2346576
- NCI Thesaurus Property
- C25678
- NCI Thesaurus ObjectClass
- C17089
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
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C0006141 (UMLS 2011AA ObjectClass-2)
C12745 (NCI Thesaurus ObjectClass-3)
C0024204 (UMLS 2011AA ObjectClass-3)
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C0031809 (UMLS 2011AA Property)
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