ID

776

Beschreibung

NSABP PROTOCOL B-35: REGISTRATION FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A053033F-8CE7-05B1-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A053033F-8CE7-05B1-E034-080020C9C0E0

Stichworte

Versionen (2)
  1. 26.08.12 26.08.12 -
  2. 18.03.15 18.03.15 - Martin Dugas
Hochgeladen am

26. August 2012

DOI

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Lizenz

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Breast Cancer NCT00053898 Registration - NSABP PROTOCOL B-35: REGISTRATION FORM - 2033723v3.0

Englisch

Form A (04-30-2002) Prior to randomization, fax Form A and signed consent to 412-383-2065.

1 Formulare  
Unnamed1
Beschreibung

Unnamed1

Patient Study ID
Beschreibung

PatientStudyID

Datentyp

text

Patient Medical Record Number
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Unnamed2
Beschreibung

Unnamed2

Institution Name
Beschreibung

InstitutionName

Datentyp

text

Institution Number
Beschreibung

NCIInstitutionNumber

Datentyp

text

Affiliate Name
Beschreibung

AffiliateName

Datentyp

text

Physician of Record (physician to whom study drug will be sent; must have a valid FDA Number)
Beschreibung

RegisteredInvestigator

Datentyp

text

Date Informed Consent Signed (Month Day Year)
Beschreibung

InformedConsentDateSigned

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Projected Start Date of Treatment (Study Drug Month Day Year)
Beschreibung

ProjectedTreatmentBeginDate

Datentyp

date

Person Completing Form Last Name
Beschreibung

PersonCompletingForm,LastName

Datentyp

text

Person Completing Form First Name
Beschreibung

PersonCompletingForm,FirstName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Person Completing Form Phone
Beschreibung

PersonCompletingForm,Phone

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Person Completing Form Fax
Beschreibung

PersonCompletingForm,Fax

Datentyp

double

Unnamed3
Beschreibung

Unnamed3

Patient Name (Last, First, MI Last First MI)
Beschreibung

PatientName

Datentyp

text

Patient's Date of Birth (Month Day Year)
Beschreibung

PatientBirthDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Patient's Social Security Number (USA only)
Beschreibung

Patient'sSocialSecurityNumber

Datentyp

text

Unnamed4
Beschreibung

Unnamed4

Race Categories
Beschreibung

RaceCategories

Datentyp

text

Ethnic Categories
Beschreibung

EthnicCategories

Datentyp

text

Unnamed5
Beschreibung

Unnamed5

Method of Payment
Beschreibung

PaymentMethod

Datentyp

text

Unnamed6
Beschreibung

Unnamed6

Country of Residence (if not USA)
Beschreibung

PatientAddress,Country

Datentyp

text

Other
Beschreibung

OtherInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Patient's zip code (USA)
Beschreibung

PatientAddress,PostalCode

Datentyp

double

Unnamed7
Beschreibung

Unnamed7

Performance Status
Beschreibung

PerformanceStatus

Datentyp

text

Patient Height (cm)
Beschreibung

PatientHeight

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Patient Weight (kg)
Beschreibung

PatientWeight

Datentyp

double

Certificate Of Eligibility
Beschreibung

Certificate Of Eligibility

In the opinion of the investigator, is the patient eligible?
Beschreibung

PatientEligibilityInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Stratification Factor
Beschreibung

Stratification Factor

Age at Registration
Beschreibung

PatientRegistrationAgeYearCount

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Unnamed8
Beschreibung

Unnamed8

Patient's Last Name
Beschreibung

PatientName,Last

Datentyp

text

Eligibility Checklist
Beschreibung

Eligibility Checklist

Verification of Postmenopausal Status (Select the item that best describes the patient.)
Beschreibung

VerificationofPostmenopausalStatus

Datentyp

text

Alias
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ObjectClass
C25171
UMLS 2011AA ObjectClass
C0013893
Date of Last Surgery for Breast Cancer Treatment ([Must be within 84 days of randomization.] Month Day Year)
Beschreibung

DateofLastSurgeryforBreastCancerTreatment

Datentyp

text

Surgical Treatment And Pathology
Beschreibung

Surgical Treatment And Pathology

Did the patient undergo lumpectomy?
Beschreibung

Didthepatientundergolumpectomy?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Was the patient diagnosed with invasive or microinvasive breast cancer?
Beschreibung

MicroinvasiveCancerInd

Datentyp

text

Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
Beschreibung

DCISInd

Datentyp

text

Alias
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ObjectClass
C2924
UMLS 2011AA ObjectClass
C0007124
NCI Thesaurus Property
C25527
UMLS 2011AA Property
C0205462
Are the final margins of the resected specimen histologically free of DCIS?
Beschreibung

ArethefinalmarginsoftheresectedspecimenhistologicallyfreeofDCIS?

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25508
UMLS 2011AA ObjectClass
C0205088
NCI Thesaurus ObjectClass
C25563
UMLS 2011AA ObjectClass
C0205284
NCI Thesaurus Property
C25547
NCI Thesaurus Property
C25527
UMLS 2011AA Property
C0205462
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Were there any clinically or mammographically suspicious masses or clusters of calcification?
Beschreibung

Werethereanyclinicallyormammographicallysuspiciousmassesorclustersofcalcification?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
Beschreibung

Ifitem6isyes,werethesesuspiciousmassesorclustersofcalcificationbiopsied?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If item 5a is yes, are the margins histologically free of DCIS?
Beschreibung

Ifitem6aisyes,arethemarginshistologicallyfreeofDCIS?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Are there suspicious palpable nodes in the ipsilateral or contralateral axilla? ([If item 6 is yes, attach pathologic documentation that these are not involved with tumor])
Beschreibung

Aretheresuspiciouspalpablenodesintheipsilateralorcontralateralaxilla?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
Beschreibung

Aretherepalpablesupraclavicularorinfraclavicularnodes?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Is there a bilateral malignancy or a mass or mammographic abnormality in the opposite breast that is suspicious for malignancy? ([If item 8 is yes, attach pathologic documentation that this is not malignant])
Beschreibung

Isthereabilateralmalignancyoramassormammographicabnormalityintheoppositebreastthatissuspiciousformalignancy?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
Beschreibung

Didthepatienthaveoneormoreipsilateralaxillarynodesorintramammarynodesthatwerepositivefortumoronhistologicexamination?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Did the patient undergo mastectomy?
Beschreibung

Didthepatientundergomastectomy?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Other Treatment
Beschreibung

Other Treatment

Has systemic or radiation therapy been given for the current DCIS?
Beschreibung

HassystemicorradiationtherapybeengivenforthecurrentDCIS?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?
Beschreibung

PriorHormonalTherapyInd

Datentyp

text

Is the patient currently taking raloxifene (Evista [R])or other selective estrogen receptor modulators (SERMs)? ([Circle "no" if this therapy is discontinued prior to randomization.])
Beschreibung

Isthepatientcurrentlytakingraloxifene(Evista[R])orotherselectiveestrogenreceptormodulators(SERMs)?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Has the patient been taking any sex hormonal therapy, e.g. estrogen or progesterone replacement therapy, oral contraceptives, androgens, etc.? ([See Protocol, Section 5.2.11])
Beschreibung

Hasthepatientbeentakinganysexhormonaltherapy,e.g.estrogenorprogesteronereplacementtherapy,oralcontraceptives,androgens,etc.?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If item 14 is yes, was this therapy discontinued prior to randomization?
Beschreibung

Ifitem15isyes,wasthistherapydiscontinuedpriortorandomization?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Unnamed9
Beschreibung

Unnamed9

Patient's Last Name
Beschreibung

PatientName,Last

Datentyp

text

Contraindications
Beschreibung

Contraindications

Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
Beschreibung

Doesthepatienthaveapriorhistoryofdeepveinthrombosisorpulmonaryembolus?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Has the patient ever been diagnosed with a non-breast malignancy?
Beschreibung

Hasthepatienteverbeendiagnosedwithanon-breastmalignancy?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If item 16 is yes, has the patient been disease-free for at least 5 years?
Beschreibung

Ifitem17isyes,hasthepatientbeendisease-freeforatleast5years?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If item 16a is no, was the diagnosis squamous or basal cell carcinoma of the skin which was effectively treated, carcinoma in situ of the cervix that has been treated by surgery alone, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralatera
Beschreibung

Ifitem17aisno,wasthediagnosissquamousorbasalcellcarcinomaoftheskinwhichwaseffectivelytreated,carcinomainsituofthecervixthathasbeentreatedbysurgeryalone,orlobularcarcinomainsitu(LCIS)oftheipsilateralorcontralatera

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
Beschreibung

PatientTransientIschemicAttackCerebrovascularAccidentPersonalMedicalHistoryInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C29867
UMLS 2011AA ObjectClass
C0679646
NCI Thesaurus Property
C50781
UMLS 2011AA Property
C0007787
NCI Thesaurus Property
C3390
UMLS 2011AA Property
C0038454
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude her being subjected to protocol therapy or would prevent prolonged follow-up?
Beschreibung

Doesthepatienthaveanonmalignantsystemicdisease(cardiovascular,renal,hepatic,etc.)thatwouldprecludeherbeingsubjectedtoprotocoltherapyorwouldpreventprolongedfollow-up?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
Beschreibung

Doesthepatienthaveapsychiatricoraddictivedisorderwhichwouldprecludeobtaininginformedconsent?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have a prior history of invasive breast cancer or DCIS?
Beschreibung

DoesthepatienthaveapriorhistoryofinvasivebreastcancerorDCIS?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have uncontrolled hypertension?
Beschreibung

Doesthepatienthaveuncontrolledhypertension?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have uncontrolled diabetes?
Beschreibung

Doesthepatienthaveuncontrolleddiabetes?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have atrial fibrillation, not controlled by medication?
Beschreibung

Doesthepatienthaveatrialfibrillation,notcontrolledbymedication?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Pre-entry Studies
Beschreibung

Pre-entry Studies

Has the patient had a history and physical in the last 6 months?
Beschreibung

Hasthepatienthadahistoryandphysicalinthelast6months?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Has the patient had a bilateral mammogram within the past 12 months?
Beschreibung

Hasthepatienthadabilateralmammogramwithinthepast12months?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Has the patient had a hysterectomy?
Beschreibung

HysterectomyPerformedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15256
UMLS 2011AA ObjectClass
C0020699
If item 26 is no, has the patient had a pelvic exam within the past 12 months?
Beschreibung

Ifitem27isno,hasthepatienthadapelvicexamwithinthepast12months?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Unnamed10
Beschreibung

Unnamed10

WBC
Beschreibung

WBC

Datentyp

text

SGOT (AST)
Beschreibung

SGOT(AST)

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Total bilirubin
Beschreibung

Totalbilirubin

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Alkaline phosphatase
Beschreibung

Alkalinephosphatase

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Serum creatinine
Beschreibung

Serumcreatinine

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Form A (04-30-2002) Prior to randomization, fax Form A and signed consent to 412-383-2065.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
PatientStudyID
Item
Patient Study ID
text
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
Item Group
Unnamed2
InstitutionName
Item
Institution Name
text
NCIInstitutionNumber
Item
Institution Number
text
AffiliateName
Item
Affiliate Name
text
RegisteredInvestigator
Item
Physician of Record (physician to whom study drug will be sent; must have a valid FDA Number)
text
InformedConsentDateSigned
Item
Date Informed Consent Signed (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ProjectedTreatmentBeginDate
Item
Projected Start Date of Treatment (Study Drug Month Day Year)
date
PersonCompletingForm,LastName
Item
Person Completing Form Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PersonCompletingForm,Phone
Item
Person Completing Form Phone
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
PersonCompletingForm,Fax
Item
Person Completing Form Fax
double
Item Group
Unnamed3
PatientName
Item
Patient Name (Last, First, MI Last First MI)
text
PatientBirthDate
Item
Patient's Date of Birth (Month Day Year)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Patient'sSocialSecurityNumber
Item
Patient's Social Security Number (USA only)
text
Item Group
Unnamed4
Item
Race Categories
text
CL.1
Code List
Race Categories
CL Item
White (White)
CL107068 (NCI Metathesaurus)
CL Item
Black or African American (Black or African American)
CL Item
Black (Black)
CL Item
Native Hawaiian Or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)
CL025744 (NCI Metathesaurus)
CL Item
Asian (Asian)
CL106519 (NCI Metathesaurus)
CL Item
American Indian Or Alaska Native (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnic Categories
text
CL.2
Code List
Ethnic Categories
CL Item
Hispanic Or Latino (Hispanic or Latino)
CL024968 (NCI Metathesaurus)
CL Item
Hispanic (Hispanic)
CL Item
Non-hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Unnamed5
Item
Method of Payment
text
CL.3
Code List
Method of Payment
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
CL Item
Medicare & Private (Medicare & Private)
CL Item
Medicaid (Medicaid)
CL Item
Medicaid & Medicare (Medicaid & Medicare)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Military or Veterans Sponsored NOS (Military or Veterans Sponsored NOS)
CL Item
Military Sponsored (incl. CHAMPUS & TRICARE) (Military Sponsored (incl. CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self pay (no insurance) (Self pay (no insurance))
CL Item
No means of payment (no insurance) (No means of payment (no insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Unnamed6
Item
Country of Residence (if not USA)
text
CL.4
Code List
Country of Residence (if not USA)
CL Item
Canada (Canada)
CL Item
Mexico (Mexico)
CL Item
Puerto Rico (Puerto Rico)
CL Item
Other (Other)
OtherInd-3
Item
Other
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PatientAddress,PostalCode
Item
Patient's zip code (USA)
double
Item Group
Unnamed7
Item
Performance Status
text
CL.5
Code List
Performance Status
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted in physically strenous activity but ambulatory (K 70-80))
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (Completely disabled (K 10-20))
PatientHeight
Item
Patient Height (cm)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Patient Weight (kg)
double
Item Group
Certificate Of Eligibility
Item
In the opinion of the investigator, is the patient eligible?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.6
Code List
In the opinion of the investigator, is the patient eligible?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
If No, The Patient Should Not Be Registered (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Stratification Factor
PatientRegistrationAgeYearCount
Item
Age at Registration
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Unnamed8
PatientName,Last
Item
Patient's Last Name
text
Item Group
Eligibility Checklist
Item
Verification of Postmenopausal Status (Select the item that best describes the patient.)
text
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)
CL.7
Code List
Verification of Postmenopausal Status (Select the item that best describes the patient.)
CL Item
Bilateral Oophorectomy (Bilateral oophorectomy)
CL Item
No Bilateral Oophorectomy And No Hysterectomy: And > 12 Months Since Lmp (No bilateral oophorectomy and no hysterectomy: and > 12 months since LMP)
CL Item
Hysterectomy But No Bilateral Oophorectomy: And Age >/=55 At Randomization (Hysterectomy but no bilateral oophorectomy: and age >/=55 at randomization)
CL Item
Hysterectomy But No Bilateral Oophorectomy: And Age </=54 At Randomization And Fsh Within The Postmenopausal Range As Determined By The Investigator (Hysterectomy but no bilateral oophorectomy: and age </=54 at randomization and FSH within the postmenopausal range as determined by the investigator)
CL Item
None Of The Above (ineligible) (None of the above (ineligible))
DateofLastSurgeryforBreastCancerTreatment
Item
Date of Last Surgery for Breast Cancer Treatment ([Must be within 84 days of randomization.] Month Day Year)
text
Item Group
Surgical Treatment And Pathology
Item
Did the patient undergo lumpectomy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.8
Code List
Did the patient undergo lumpectomy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was the patient diagnosed with invasive or microinvasive breast cancer?
text
CL.9
Code List
Was the patient diagnosed with invasive or microinvasive breast cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
text
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
CL.10
Code List
Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Are the final margins of the resected specimen histologically free of DCIS?
text
C25508 (NCI Thesaurus ObjectClass)
C0205088 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus ObjectClass)
C0205284 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.11
Code List
Are the final margins of the resected specimen histologically free of DCIS?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were there any clinically or mammographically suspicious masses or clusters of calcification?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
Code List
Were there any clinically or mammographically suspicious masses or clusters of calcification?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.13
Code List
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If item 5a is yes, are the margins histologically free of DCIS?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.14
Code List
If item 5a is yes, are the margins histologically free of DCIS?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Are there suspicious palpable nodes in the ipsilateral or contralateral axilla? ([If item 6 is yes, attach pathologic documentation that these are not involved with tumor])
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.15
Code List
Are there suspicious palpable nodes in the ipsilateral or contralateral axilla? ([If item 6 is yes, attach pathologic documentation that these are not involved with tumor])
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.16
Code List
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there a bilateral malignancy or a mass or mammographic abnormality in the opposite breast that is suspicious for malignancy? ([If item 8 is yes, attach pathologic documentation that this is not malignant])
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.17
Code List
Is there a bilateral malignancy or a mass or mammographic abnormality in the opposite breast that is suspicious for malignancy? ([If item 8 is yes, attach pathologic documentation that this is not malignant])
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.18
Code List
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient undergo mastectomy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.19
Code List
Did the patient undergo mastectomy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Other Treatment
Item
Has systemic or radiation therapy been given for the current DCIS?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.20
Code List
Has systemic or radiation therapy been given for the current DCIS?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?
text
CL.21
Code List
Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient currently taking raloxifene (Evista [R])or other selective estrogen receptor modulators (SERMs)? ([Circle "no" if this therapy is discontinued prior to randomization.])
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.22
Code List
Is the patient currently taking raloxifene (Evista [R])or other selective estrogen receptor modulators (SERMs)? ([Circle "no" if this therapy is discontinued prior to randomization.])
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient been taking any sex hormonal therapy, e.g. estrogen or progesterone replacement therapy, oral contraceptives, androgens, etc.? ([See Protocol, Section 5.2.11])
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.23
Code List
Has the patient been taking any sex hormonal therapy, e.g. estrogen or progesterone replacement therapy, oral contraceptives, androgens, etc.? ([See Protocol, Section 5.2.11])
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If item 14 is yes, was this therapy discontinued prior to randomization?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.24
Code List
If item 14 is yes, was this therapy discontinued prior to randomization?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed9
PatientName,Last
Item
Patient's Last Name
text
Item Group
Contraindications
Item
Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.25
Code List
Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient ever been diagnosed with a non-breast malignancy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.26
Code List
Has the patient ever been diagnosed with a non-breast malignancy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If item 16 is yes, has the patient been disease-free for at least 5 years?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.27
Code List
If item 16 is yes, has the patient been disease-free for at least 5 years?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If item 16a is no, was the diagnosis squamous or basal cell carcinoma of the skin which was effectively treated, carcinoma in situ of the cervix that has been treated by surgery alone, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralatera
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.28
Code List
If item 16a is no, was the diagnosis squamous or basal cell carcinoma of the skin which was effectively treated, carcinoma in situ of the cervix that has been treated by surgery alone, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralatera
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
text
C29867 (NCI Thesaurus ObjectClass)
C0679646 (UMLS 2011AA ObjectClass)
C50781 (NCI Thesaurus Property)
C0007787 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.29
Code List
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude her being subjected to protocol therapy or would prevent prolonged follow-up?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.30
Code List
Does the patient have a nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude her being subjected to protocol therapy or would prevent prolonged follow-up?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.31
Code List
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a prior history of invasive breast cancer or DCIS?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.32
Code List
Does the patient have a prior history of invasive breast cancer or DCIS?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have uncontrolled hypertension?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.33
Code List
Does the patient have uncontrolled hypertension?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have uncontrolled diabetes?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.34
Code List
Does the patient have uncontrolled diabetes?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have atrial fibrillation, not controlled by medication?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.35
Code List
Does the patient have atrial fibrillation, not controlled by medication?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Pre-entry Studies
Item
Has the patient had a history and physical in the last 6 months?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.36
Code List
Has the patient had a history and physical in the last 6 months?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had a bilateral mammogram within the past 12 months?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.37
Code List
Has the patient had a bilateral mammogram within the past 12 months?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had a hysterectomy?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
CL.38
Code List
Has the patient had a hysterectomy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If item 26 is no, has the patient had a pelvic exam within the past 12 months?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.39
Code List
If item 26 is no, has the patient had a pelvic exam within the past 12 months?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed10
Item
WBC
text
CL.40
Code List
WBC
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
SGOT (AST)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.41
Code List
SGOT (AST)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Total bilirubin
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.42
Code List
Total bilirubin
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Alkaline phosphatase
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.43
Code List
Alkaline phosphatase
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Serum creatinine
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.44
Code List
Serum creatinine
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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