ID

8931

Beschrijving

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

Trefwoorden

  1. 26-08-12 26-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Breast Cancer NCT00066807 Registration - Confirmation of Registration Form (Form 26-A) - 2167967v3.0

No Instruction available.

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

Ccrr Module For Registration Form (form 26 A)

Patient ID No.
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Patient Initials
Beschrijving

Patient Initials

Datatype

text

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

Birth Date

Datatype

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
Beschrijving

ParticipatingCenter/Affiliate

Datatype

text

Center Code
Beschrijving

ParticipatingGroupCode

Datatype

text

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

PMDCode

Datatype

text

Premenopausal
Beschrijving

Premenopausal

Datatype

boolean

Suitable for adding chemotherapy to the adjuvant systemic therapy
Beschrijving

Suitableforaddingchemotherapytotheadjuvantsystemictherapy

Datatype

boolean

Randomized within 12 weeks after definite surgery
Beschrijving

Randomizedwithin12weeksafterdefinitesurgery

Datatype

boolean

To be selected by subsequent randomization to the TEXT trial
Beschrijving

TobeselectedbysubsequentrandomizationtotheTEXTtrial

Datatype

boolean

Tamoxifen
Beschrijving

Tamoxifen

Datatype

boolean

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

Exemestane

Datatype

boolean

Histologically proven, resected breast cancer
Beschrijving

Histologicallyproven,resectedbreastcancer

Datatype

boolean

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

Estrogenand/orprogesteronereceptorPostitivetumorwhichisdefinedas>or=10%oftumorcellspositivebyimmunohistochemicalevaluation

Datatype

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.
Beschrijving

Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.

Datatype

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.
Beschrijving

TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

Datatype

boolean

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

EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.

Datatype

boolean

No locally advanced inoperable or inflammatory breast cancer
Beschrijving

Nolocallyadvancedinoperableorinflammatorybreastcancer

Datatype

boolean

no bilateral invasive breast cancer.
Beschrijving

Nobilateralinvasivebreastcancer.

Datatype

boolean

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

Finalmarginsnegative

Datatype

boolean

No clinically detectable residual axillary disease.
Beschrijving

Noclinicallydetectableresidualaxillarydisease.

Datatype

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.
Beschrijving

Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.

Datatype

boolean

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

Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

Datatype

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.
Beschrijving

NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.

Datatype

boolean

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

Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

Datatype

boolean

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

Nopriorbilateraloophorectomyorovarianreduction.

Datatype

boolean

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

Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.

Datatype

boolean

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

Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

Datatype

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.
Beschrijving

Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.

Datatype

boolean

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

Noendocrinetherapyafterbreastcancerdiagnosis.

Datatype

boolean

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

NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.

Datatype

boolean

Has not received neoadjuvant or adjuvant chemotherapy.
Beschrijving

Noneoadjuvantoradjuvantchemotherapy.

Datatype

boolean

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

Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

Datatype

boolean

Accessible for follow-up.
Beschrijving

Accessibleforfollow-up.

Datatype

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.
Beschrijving

Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.

Datatype

boolean

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

AreallanswerstotheEligibilityChecklistYES?

Datatype

boolean

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

Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?

Datatype

boolean

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

DateInformedConsentFormsignedbypatient

Datatype

text

Date informed consent form signed by investigator
Beschrijving

DateInformedConsentFormsignedbyInvestigator

Datatype

text

Is protocol-required pathology material available
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
give reason
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
Have baseline QL Core and module forms been completed?
Beschrijving

HavebaselineQLCoreandmoduleformsbeencompleted?

Datatype

text

Other reason, specify (QL forms not completed)
Beschrijving

no,otherreason,specify(QLformsnotcompleted)

Datatype

text

Date baseline QL forms were completed
Beschrijving

DatebaselineQLformswerecompleted

Datatype

text

Tumor Laterality
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
Right Breast/Side
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
Left Breast/Side
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
Intended method of ovarian function suppression
Beschrijving

Intendedmethodofovarianfunctionsuppression

Datatype

text

Intended chemotherapy
Beschrijving

Intendedchemotherapy

Datatype

text

Intended endocrine agent
Beschrijving

Intendedendocrineagent

Datatype

text

Projected Treatment Begin Date
Beschrijving

Treatment Begin Date

Datatype

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)
Beschrijving

PrimarySurgeryDate

Datatype

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)
Beschrijving

PrimarySurgeryDate

Datatype

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)
Beschrijving

PrimarySurgeryType

Datatype

text

Most Extensive Primary Surgery (Left breast/side)
Beschrijving

PrimarySurgeryType

Datatype

text

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

Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

Datatype

boolean

Specimen ID Number (Left breast/side)
Beschrijving

SpecimenIdentifierNumber

Datatype

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)
Beschrijving

SpecimenIdentifierNumber

Datatype

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
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
Pathology Institute Code
Beschrijving

PathologyInstituteCode

Datatype

text

Full name of person randomizing at participating center
Beschrijving

Fullnameofpersonrandomizingatparticipatingcenter

Datatype

text

Fax Number
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
Phone number
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
Full name of investigator responsible for confirming eligibility
Beschrijving

Fullnameofinvestigatorresponsibleforconfirmingeligibility

Datatype

text

Treating physician
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
IBCSG Patient ID
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
Assigned Treatment Arm
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
Randomization Date
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
Name of person who perfomed randomization at Randomization Center
Beschrijving

NameofpersonwhoperfomedrandomizationatRandomizationCenter

Datatype

text

NCI Investigator Number Code
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
Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

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

Similar models

No Instruction available.

  1. StudyEvent: Confirmation of Registration Form (Form 26-A)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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
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)
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)
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)
Code List
Left Breast/Side
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
Item
Intended method of ovarian function suppression
text
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
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
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
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
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)
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)

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial