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

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA065B-0F5E-629F-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Registration - Confirmation of Registration Form (Form 24-A) - 2072688v3.0

English

CONFIRMATION OF REGISTRATIN FORM (Form 24-A)

1 forms  
  1. StudyEvent: Confirmation of Registration Form (Form 24-A)
    1. CONFIRMATION OF REGISTRATIN FORM (Form 24-A)
Ccrr Module For Confirmation Of Registration Form (form 24-a)
Description

Ccrr Module For Confirmation Of Registration Form (form 24-a)

Patient ID No. (Study No.)
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (f m fl sl)
Description

Patient Initials

Data type

text

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

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Participating Center/Affiliate
Description

ParticipatingCenter/Affiliate

Data type

text

Center Code
Description

ParticipatingGroupCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
PMD Code (Swiss centers ONLY)
Description

PMDCode

Data type

text

Eligibility Checklist
Description

Eligibility Checklist

Randomized within 12 weeks after definitive surgery.
Description

Randomizedwithin12weeksafterdefinitivesurgery.

Data type

boolean

Premenopausal [estrodiol (E2) in premenopausal range] following surgery.
Description

Premenopausal[estrodiol(E2)inpremenopausalrange]followingsurgery.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Randomized after completing chemotherapy and within 6 months of the final dose of chemotherapy as soon as premenopausal status is confirmed.
Description

Randomizedaftercompletingchemotherapyandwithin6monthsofthefinaldoseofchemotherapyassoonaspremenopausalstatusisconfirmed.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Premenopausal [estrodiol (E2) in premenopausal range] between 2 weeks and 6 months after completing chemotherapy.
Description

Premenopausal[estrodiol(E2)inpremenopausalrange]between2weeksand6monthsaftercompletingchemotherapy.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Histologically proven, resected breast cancer.
Description

Histologicallyproven,resectedbreastcancer.

Data type

boolean

Estrogen and/or progesterone receptor POSITIVE tumor which is defined as . Or = 10% of the tumor cells positive by immunohistochemical evaluation.
Description

Estrogenand/orprogesteronereceptorPOSITIVEtumorwhichisdefinedas.Or=10%ofthetumorcellspositivebyimmunohistochemicalevaluation.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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. Patients who received neoadjuvant therapy must have had op
Description

Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.Patientswhoreceivedneoadjuvanttherapymusthavehadop

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total mastectomy (with or without radiotherapy planned) 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.
Description

Totalmastectomy(withorwithoutradiotherapyplanned)ORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Either axillary lymph node dissection OR negative axillary sentinel node biopsy and workup. Patients with H&E positive axillary nodes require axillary dissection, except for patients with microscopically positive (pN1 mi: micrometastasis < 2mm) axillary
Description

EitheraxillarylymphnodedissectionORnegativeaxillarysentinelnodebiopsyandworkup.PatientswithH&Epositiveaxillarynodesrequireaxillarydissection,exceptforpatientswithmicroscopicallypositive(pN1mi:micrometastasis<2mm)axillary

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Eligibility Checklist
Description

Eligibility Checklist

No locally advanced inoperable or inflammatory breast cancer.
Description

Nolocallyadvancedinoperableorinflammatorybreastcancer.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No bilateral invasive breast cancer.
Description

Nobilateralinvasivebreastcancer.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Final margins negative (referring to DCIS and invasive cancer, not LCIS.)
Description

Finalmarginsnegative

Data type

boolean

No clinically detectable residual axillary disease.
Description

Noclinicallydetectableresidualaxillarydisease.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No supraclavicular node involvement or evidence of distant metastatic disease.
Description

Nosupraclavicularnodeinvolvementorevidenceofdistantmetastaticdisease.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No history of prior ipsilateral or contralateral invasive breast cancer.
Description

Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

Data type

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.
Description

NopreviousorconcomitantmalignancyEXCEPTadequatelytreatedbasalorsquamouscellcarcinomaoftheskin,orinsitucarcinomaofthecervixorbladder,orcontra-oripsilateralinsitubreastcarcinoma.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No non-malignant systemic diseases that would prevent prolonged follow-up.
Description

Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No prior bilateral oophorectomy or ovarian radiation, and no plan for oophorectomy within five years
Description

Nopriorbilateraloophorectomyorovarianradiation,andnoplanforoophorectomywithinfiveyears

Data type

text

(except if randomized to OFS).
Description

(exceptifrandomizedtoOFS).

Data type

boolean

No history of noncompliance to medical regimens and not considered potentially unreliable.
Description

Nohistoryofnoncompliancetomedicalregimensandnotconsideredpotentiallyunreliable.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
Description

Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

Data type

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.
Description

Notplanningtouseadditionalhormonaltreatmentapartfromrandomizedtreatmentduringthenextfiveyears,includingalltypesofhormonalcontraception.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No more than six months of endocrine treatment (adjuvant and neoadjuvant) after breast cancer diagnosis.
Description

Nomorethansixmonthsofendocrinetreatment(adjuvantandneoadjuvant)afterbreastcancerdiagnosis.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No Tamoxifen, other SERM (e.g. Raloxifene), or HRT within 1 year prior to diagnosis.
Description

NoTamoxifen,otherSERM(e.g.Raloxifene),orHRTwithin1yearpriortodiagnosis.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has not taken GnRH analogue for breast cancer treatment.
Description

HasnottakenGnRHanalogueforbreastcancertreatment.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No psychiatric, addictive or other disorder which compromises ability to give informed consent for participation in study.
Description

Nopsychiatric,addictiveorotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Accessible for follow-up.
Description

Accessibleforfollow-up.

Data type

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.
Description

Informedandagreedtodataandtissuematerialtransferandhandling,inaccordancewithnationaldataprotectionguidelines.

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Are all the answers to the Eligibility Checklist YES? (must be yes to randomize)
Description

ArealltheanswerstotheEligibilityChecklistYES?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has Informed Consent Form been signed and dated by the patient and Investigator? (must be yes to randomize)
Description

PatientConsentSignedIndicator

Data type

boolean

Date Informed Consent Form signed by patient ( must be entered to randomize)
Description

DateInformedConsentFormsignedbypatient

Data type

text

Date Informed Consent Form signed by Investigator (must be entered to randomize)
Description

DateInformedConsentFormsignedbyInvestigator

Data type

text

Is protocol-required pathology material available
Description

SpecimenCollectedIBCSGStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
give reason
Description

SpecimenCollectedIBCSGSpecify

Data type

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?
Description

HavebaselineQLCoreandmoduleformsbeencompleted?

Data type

text

Other reason, specify (QL forms not completed)
Description

no,otherreason,specify(QLformsnotcompleted)

Data type

text

Date baseline QL forms were completed
Description

DatebaselineQLformswerecompleted

Data type

text

Stratification Factors
Description

Stratification Factors

Prior adjuvant and/or neoadjuvant chemotherapy
Description

PriorChemotherapyAdministeredIBCSGInd-2

Data type

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
Tumor Laterality
Description

PrimaryTumorLateralityType

Data type

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
Description

RightBreastLymphNodeAssessmentStatus

Data type

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
Description

LeftBreastLymphNodeAssessmentStatus

Data type

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 if patient is randomized to OFS:
Description

IntendedmethodofovarianfunctionsuppressionifpatientisrandomizedtoOFS:

Data type

text

Date of the last dose of chemotherapy
Description

ChemotherapyLastAdministeredDate

Data type

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
Date of Most Extensive Primary Surgery (day month year)
Description

PrimarySurgeryDate

Data type

date

Date of Most Extensive Primary Surgery (day month year)
Description

PrimarySurgeryDate

Data type

date

Most Extensive Primary Surgery (Left breast/side)
Description

PrimarySurgeryType

Data type

text

Most Extensive Primary Surgery (Left breast/side)
Description

PrimarySurgeryType

Data type

text

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

Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

Data type

boolean

Specimen ID Number (Left breast/side)
Description

SpecimenID

Data type

float

Specimen ID Number (Left breast/side)
Description

SpecimenID

Data type

float

Lab Facility Name
Description

SpecimenLabIdentifierName

Data type

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
Description

PathologyInstituteCode

Data type

text

Full name of person randomizing at Participating Center
Description

RandomizationPersonName

Data type

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
Fax Number
Description

PersonFaxNumber

Data type

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
Description

OrganizationPhoneNumber

Data type

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
Description

Fullnameofinvestigatorresponsibleforconfirmingeligibility

Data type

text

Treating physician
Description

TreatingPhysicianName

Data type

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
Description

PatientInternationalBreastCancerStudyGroupIdentifierNumber

Data type

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
Description

TreatmentArmIBCSGType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus ObjectClass
C15368
Randomization Date
Description

ProtocolRandomizationDate

Data type

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 performed randomization at Randomization Center
Description

NameofpersonwhoperformedrandomizationatRandomizationCenter

Data type

text

NCI Investigator Number Code
Description

NationalCancerInstitutePrincipalInvestigatorIdentifierIBCSGText

Data type

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
Description

Investigator Signature

Data type

text

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

Investigator Signature Date

Data type

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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Similar models

CONFIRMATION OF REGISTRATIN FORM (Form 24-A)

1 forms
  1. StudyEvent: Confirmation of Registration Form (Form 24-A)
    1. CONFIRMATION OF REGISTRATIN FORM (Form 24-A)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Confirmation Of Registration Form (form 24-a)
PatientStudyID,CoordinatingGroup
Item
Patient ID No. (Study No.)
text
Patient Initials
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA 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 (Swiss centers ONLY)
text
Item Group
Eligibility Checklist
Randomizedwithin12weeksafterdefinitivesurgery.
Item
Randomized within 12 weeks after definitive surgery.
boolean
Premenopausal[estrodiol(E2)inpremenopausalrange]followingsurgery.
Item
Premenopausal [estrodiol (E2) in premenopausal range] following surgery.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Randomizedaftercompletingchemotherapyandwithin6monthsofthefinaldoseofchemotherapyassoonaspremenopausalstatusisconfirmed.
Item
Randomized after completing chemotherapy and within 6 months of the final dose of chemotherapy as soon as premenopausal status is confirmed.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Premenopausal[estrodiol(E2)inpremenopausalrange]between2weeksand6monthsaftercompletingchemotherapy.
Item
Premenopausal [estrodiol (E2) in premenopausal range] between 2 weeks and 6 months after completing chemotherapy.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Histologicallyproven,resectedbreastcancer.
Item
Histologically proven, resected breast cancer.
boolean
Estrogenand/orprogesteronereceptorPOSITIVEtumorwhichisdefinedas.Or=10%ofthetumorcellspositivebyimmunohistochemicalevaluation.
Item
Estrogen and/or progesterone receptor POSITIVE tumor which is defined as . Or = 10% of the tumor cells positive by immunohistochemical evaluation.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.Patientswhoreceivedneoadjuvanttherapymusthavehadop
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. Patients who received neoadjuvant therapy must have had op
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Totalmastectomy(withorwithoutradiotherapyplanned)ORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.
Item
Total mastectomy (with or without radiotherapy planned) 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
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
EitheraxillarylymphnodedissectionORnegativeaxillarysentinelnodebiopsyandworkup.PatientswithH&Epositiveaxillarynodesrequireaxillarydissection,exceptforpatientswithmicroscopicallypositive(pN1mi:micrometastasis<2mm)axillary
Item
Either axillary lymph node dissection OR negative axillary sentinel node biopsy and workup. Patients with H&E positive axillary nodes require axillary dissection, except for patients with microscopically positive (pN1 mi: micrometastasis < 2mm) axillary
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Eligibility Checklist
Nolocallyadvancedinoperableorinflammatorybreastcancer.
Item
No locally advanced inoperable or inflammatory breast cancer.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Nobilateralinvasivebreastcancer.
Item
No bilateral invasive breast cancer.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Finalmarginsnegative
Item
Final margins negative (referring to DCIS and invasive cancer, not LCIS.)
boolean
Noclinicallydetectableresidualaxillarydisease.
Item
No clinically detectable residual axillary disease.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Nosupraclavicularnodeinvolvementorevidenceofdistantmetastaticdisease.
Item
No supraclavicular node involvement or evidence of distant metastatic disease.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.
Item
No non-malignant systemic diseases that would prevent prolonged follow-up.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Nopriorbilateraloophorectomyorovarianradiation,andnoplanforoophorectomywithinfiveyears
Item
No prior bilateral oophorectomy or ovarian radiation, and no plan for oophorectomy within five years
text
(exceptifrandomizedtoOFS).
Item
(except if randomized to OFS).
boolean
Nohistoryofnoncompliancetomedicalregimensandnotconsideredpotentiallyunreliable.
Item
No history of noncompliance to medical regimens and not considered potentially unreliable.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
Nomorethansixmonthsofendocrinetreatment(adjuvantandneoadjuvant)afterbreastcancerdiagnosis.
Item
No more than six months of endocrine treatment (adjuvant and neoadjuvant) after breast cancer diagnosis.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NoTamoxifen,otherSERM(e.g.Raloxifene),orHRTwithin1yearpriortodiagnosis.
Item
No Tamoxifen, other SERM (e.g. Raloxifene), or HRT within 1 year prior to diagnosis.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HasnottakenGnRHanalogueforbreastcancertreatment.
Item
Has not taken GnRH analogue for breast cancer treatment.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Nopsychiatric,addictiveorotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.
Item
No psychiatric, addictive or other disorder which compromises ability to give informed consent for participation in study.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
ArealltheanswerstotheEligibilityChecklistYES?
Item
Are all the answers to the Eligibility Checklist YES? (must be yes to randomize)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientConsentSignedIndicator
Item
Has Informed Consent Form been signed and dated by the patient and Investigator? (must be yes to randomize)
boolean
DateInformedConsentFormsignedbypatient
Item
Date Informed Consent Form signed by patient ( must be entered to randomize)
text
DateInformedConsentFormsignedbyInvestigator
Item
Date Informed Consent Form signed by Investigator (must be entered to randomize)
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)
CL.30
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
CL.31
Code List
Have baseline QL Core and module forms been completed?
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)
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)
no,otherreason,specify(QLformsnotcompleted)
Item
Other reason, specify (QL forms not completed)
text
DatebaselineQLformswerecompleted
Item
Date baseline QL forms were completed
text
Item Group
Stratification Factors
PriorChemotherapyAdministeredIBCSGInd-2
Item
Prior adjuvant and/or neoadjuvant chemotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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)
CL.33
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)
CL.34
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)
CL.35
Code List
Left Breast/Side
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
Item
Intended method of ovarian function suppression if patient is randomized to OFS:
text
CL.36
Code List
Intended method of ovarian function suppression if patient is randomized to OFS:
CL Item
Gnrh Analogue X 5 Years (GnRH analogue x 5 years)
CL Item
Surgical Oophorectomy (Surgical oophorectomy)
CL Item
Ovarian Irradiation (Ovarian irradiation)
ChemotherapyLastAdministeredDate
Item
Date of the last dose of chemotherapy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery (day month year)
date
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery (day month year)
date
Item
Most Extensive Primary Surgery (Left breast/side)
text
CL.38
Code List
Most Extensive Primary Surgery (Left breast/side)
CL Item
Less Than Mastectomy (Less than mastectomy)
CL Item
Mastectomy (Mastectomy)
C15277 (NCI Thesaurus)
C0024881 (UMLS 2011AA)
Item
Most Extensive Primary Surgery (Left breast/side)
text
CL.38
Code List
Most Extensive Primary Surgery (Left breast/side)
CL Item
Less Than Mastectomy (Less than mastectomy)
CL Item
Mastectomy (Mastectomy)
C15277 (NCI Thesaurus)
C0024881 (UMLS 2011AA)
Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?
Item
Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
boolean
SpecimenID
Item
Specimen ID Number (Left breast/side)
float
SpecimenID
Item
Specimen ID Number (Left breast/side)
float
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
RandomizationPersonName
Item
Full name of person randomizing at Participating Center
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25196 (NCI Thesaurus ObjectClass-2)
C0034656 (UMLS 2011AA ObjectClass-2)
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)
CL.40
Code List
Assigned Treatment Arm
CL Item
Exemestane For 5 Years With Ovarian Function Suppression (Exemestane for 5 years with ovarian function suppression)
CL Item
Tamoxifen For 5 Years (Tamoxifen for 5 years)
CL Item
Tamoxifen For 5 Years With Ovarian Function Suppression (Tamoxifen for 5 years with ovarian function suppression)
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)
NameofpersonwhoperformedrandomizationatRandomizationCenter
Item
Name of person who performed 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)
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