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1 forms
  1. StudyEvent: Confirmation of Registration Form (Form 26-A)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
CL.32
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.33
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)
CL.34
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.35
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.36
Code List
Left Breast/Side
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
Item
Intended method of ovarian function suppression
text
CL.37
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
CL.38
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
CL.39
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
CL.41
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
CL.41
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)
CL.43
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)
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