ID

793

Description

Confirmation of Registration Form (Form 25-A) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD163BF2-874D-4FBE-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD163BF2-874D-4FBE-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00066703 Registration - Confirmation of Registration Form (Form 25-A) - 2168101v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Confirmation of Registration Form (Form 25-A)
    1. No Instruction available.
Ccrr Module For Registration Form (form 25-a)
Description

Ccrr Module For Registration Form (form 25-a)

Patient ID No.
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient's Date of Birth
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
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
Description

PMDCode

Data type

text

Premenopausal
Description

Premenopausal

Data type

text

Randomized within 12 weeks after definite surgery prior to commencing any adjuvant systemic therapy
Description

Randomizedwithin12weeksafterdefinitesurgerypriortocommencinganyadjuvantsystemictherapy

Data type

text

Histologically proven, resected breast cancer
Description

Histologicallyproven,resectedbreastcancer

Data type

text

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

Estrogenand/orprogesteronereceptorPostitivetumorwhichisdefinedas>or=10%oftumorcellspositivebyimmunohistochemicalevaluation

Data type

text

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.
Description

Thetumormustbeconfinedtothebreastandaxillarynodeswithoutdetectedmetastaseselsewhere,withtheexceptionoftumordetectedininternalmammarychainnodesbysentinelnodeprocedure.

Data type

text

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.
Description

TotalmastectomyORbreast-conservingprocedurewithradiotherapytotheconservedbreastplanned.MarginsmustbeclearofinvasivecancerandDCIS.Documentedclearmarginsofresectioninpathologyreport.

Data type

text

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

EitheraxillarylymphnodedissectionORnegativeaxillarynodebiopsyandworkup.

Data type

text

No locally advanced inoperable or inflammatory breast cancer
Description

Nolocallyadvancedinoperableorinflammatorybreastcancer

Data type

text

no bilateral invasive breast cancer.
Description

Nobilateralinvasivebreastcancer.

Data type

text

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

Finalmarginsnegative

Data type

text

No clinically detectable residual axillary disease.
Description

Noclinicallydetectableresidualaxillarydisease.

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
Description

Nosupraclavicularnodeinvovlement,noenlargedinternalmammarynodes,noevidenceofdistantmetastaticdisease.

Data type

text

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

Nohistoryofprioripsilateralorcontralateralinvasivebreastcancer.

Data type

text

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

text

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

Nonon-malignantsystemicdiseasesthatwouldpreventprolongedfollow-up.

Data type

text

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

Nopriorbilateraloophorectomyorovarianreduction.

Data type

text

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

Nohistoryofnoncompliancetomedicalregimensandnoconsideredpotentiallyunreliable.

Data type

text

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

Notpregnantorlactatingatthetimeofrandomizationanddoesnotdesirepregnancywithinfiveyears.

Data type

text

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

text

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

Noendocrinetherapyafterbreastcancerdiagnosis.

Data type

text

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

NoTamoxifen,otherSERM,orHRTwithin1yearpriortodiagnosis.Priororalcontraceptivesareallowed.

Data type

text

No neoadjuvant or adjuvant chemotherapy.
Description

Noneoadjuvantoradjuvantchemotherapy.

Data type

text

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

Nophychiatric,addictive,orotherdisorderwhichcompromisesabilitytogiveinformedconsentforparticipationinstudy.

Data type

text

Accessible for follow-up.
Description

Accessibleforfollow-up.

Data type

text

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

text

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

AreallanswerstotheEligibilityChecklistYES?

Data type

text

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

Hasinformedconsentformbeensignedanddatedbythepatientandinvestigator?

Data type

text

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

DateInformedConsentFormsignedbypatient

Data type

text

Date informed consent form signed by investigator
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

Was the patient randomized to Trial 26-02
Description

PatientRandomizationIBCSGInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Metathesaurus ObjectClass
C0030705
Will adjuvant chemotherapy be given?
Description

Willadjuvantchemotherapybegiven?

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Projected Treatment Begin Date
Description

ProjectedTreatmentBeginDate

Data type

date

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
C25251
UMLS 2011AA ObjectClass
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
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
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
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Date of Most Extensive Primary Surgery (Left breast/side)
Description

PrimarySurgeryDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date of Most Extensive Primary Surgery (Left breast/side)
Description

PrimarySurgeryDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Most Extensive Primary Surgery (Right breast/side)
Description

PrimarySurgeryType

Data type

text

Most Extensive Primary Surgery (Right breast/side)
Description

PrimarySurgeryType

Data type

text

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

Isadjuvantbreast/chestwallradiotherapyplanned,ongoingorcompleted?

Data type

text

Specimen ID Number (Right breast/side)
Description

SpecimenIdentifierNumber

Data type

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)
Description

SpecimenID

Data type

double

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
C19157
UMLS 2011AA ObjectClass
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
C25196
UMLS 2011AA ObjectClass
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
C25210
UMLS 2011AA ValueDomain
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
C25705
UMLS 2011AA ObjectClass
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
C25530
UMLS 2011AA Property
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 perfomed randomization at Randomization Center
Description

NameofpersonwhoperfomedrandomizationatRandomizationCenter

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
C19924
UMLS 2011AA ObjectClass
C1521895
Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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1 forms
  1. StudyEvent: Confirmation of Registration Form (Form 25-A)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Registration Form (form 25-a)
PatientStudyID,CoordinatingGroup
Item
Patient ID No.
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientBirthDate
Item
Patient's Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (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
text
Item
Premenopausal
text
CL.1
Code List
Premenopausal
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Randomized within 12 weeks after definite surgery prior to commencing any adjuvant systemic therapy
text
CL.2
Code List
Randomized within 12 weeks after definite surgery prior to commencing any adjuvant systemic therapy
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Histologically proven, resected breast cancer
text
CL.3
Code List
Histologically proven, resected breast cancer
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation
text
CL.4
Code List
Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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.
text
CL.5
Code List
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.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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.
text
CL.6
Code List
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.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Either axillary lymph node dissection OR negative axillary node biopsy and workup.
text
CL.7
Code List
Either axillary lymph node dissection OR negative axillary node biopsy and workup.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No locally advanced inoperable or inflammatory breast cancer
text
CL.8
Code List
No locally advanced inoperable or inflammatory breast cancer
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
no bilateral invasive breast cancer.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.9
Code List
no bilateral invasive breast cancer.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Final margins negative
text
CL.10
Code List
Final margins negative
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No clinically detectable residual axillary disease.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.11
Code List
No clinically detectable residual axillary disease.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
text
CL.12
Code List
No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No history of prior ipsilateral or contralateral invasive breast cancer.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.13
Code List
No history of prior ipsilateral or contralateral invasive breast cancer.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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.
text
CL.14
Code List
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.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No non-malignant systemic diseases that would prevent prolonged follow-up.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.15
Code List
No non-malignant systemic diseases that would prevent prolonged follow-up.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No prior bilateral oophorectomy or ovarian reduction.
text
CL.16
Code List
No prior bilateral oophorectomy or ovarian reduction.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No history of noncompliance to medical regimens and no considered potentially unreliable.
text
CL.17
Code List
No history of noncompliance to medical regimens and no considered potentially unreliable.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.18
Code List
Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No endocrine therapy after breast cancer diagnosis.
text
CL.20
Code List
No endocrine therapy after breast cancer diagnosis.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
text
CL.21
Code List
No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No neoadjuvant or adjuvant chemotherapy.
text
CL.22
Code List
No neoadjuvant or adjuvant chemotherapy.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study.
text
CL.23
Code List
No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Accessible for follow-up.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.24
Code List
Accessible for follow-up.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.25
Code List
Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Are all answers to the Eligibility Checklist YES?
text
CL.26
Code List
Are all answers to the Eligibility Checklist YES?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has informed consent form been signed and dated by the patient and investigator?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.27
Code List
Has informed consent form been signed and dated by the patient and investigator?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
CL.28
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.29
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
Was the patient randomized to Trial 26-02
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C0030705 (NCI Metathesaurus ObjectClass)
CL.30
Code List
Was the patient randomized to Trial 26-02
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Will adjuvant chemotherapy be given?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.31
Code List
Will adjuvant chemotherapy be given?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProjectedTreatmentBeginDate
Item
Projected Treatment Begin Date
date
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
CL.32
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)
C0006141 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.33
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)
C0006141 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.34
Code List
Left Breast/Side
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery (Left breast/side)
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery (Left breast/side)
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item
Most Extensive Primary Surgery (Right breast/side)
text
CL.36
Code List
Most Extensive Primary Surgery (Right 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 (Right breast/side)
text
CL.36
Code List
Most Extensive Primary Surgery (Right breast/side)
CL Item
Less Than Mastectomy (Less than mastectomy)
CL Item
Mastectomy (Mastectomy)
C15277 (NCI Thesaurus)
C0024881 (UMLS 2011AA)
Item
Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
text
CL.37
Code List
Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SpecimenIdentifierNumber
Item
Specimen ID Number (Right 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)
SpecimenID
Item
Specimen ID Number (Left breast/side)
double
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)
C0370003 (UMLS 2011AA ObjectClass)
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)
C0034656 (UMLS 2011AA ObjectClass)
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)
C0085205 (UMLS 2011AA ValueDomain)
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)
C1522326 (UMLS 2011AA ObjectClass)
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)
C1512890 (UMLS 2011AA Property)
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.38
Code List
Assigned Treatment Arm
CL Item
Triptorelin For 5 Years Plus Exemestane For 5 Years (Triptorelin for 5 years plus Exemestane for 5 years)
CL Item
Triptorelin For 5 Years Plus Tamoxifen For 5 Years (Triptorelin for 5 years plus Tamoxifen 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)
C1521895 (UMLS 2011AA ObjectClass)
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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