ID

10019

Beskrivning

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 NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A053033F-8CE7-05B1-E034-080020C9C0E0

Länk

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

Nyckelord

Versioner (2)
  1. 2012-08-26 2012-08-26 -
  2. 2015-03-18 2015-03-18 - Martin Dugas
Uppladdad den

18 mars 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00053898 Registration - NSABP PROTOCOL B-35: REGISTRATION FORM - 2033723v3.0

Engelsk

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

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Patient Study ID
Beskrivning

PatientStudyID

Datatyp

text

Patient Medical Record Number
Beskrivning

PatientMedicalRecordNumber

Datatyp

text

Institution Name
Beskrivning

InstitutionName

Datatyp

text

Institution Number
Beskrivning

NCIInstitutionNumber

Datatyp

text

Affiliate Name
Beskrivning

AffiliateName

Datatyp

text

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

RegisteredInvestigator

Datatyp

text

Date Informed Consent Signed
Beskrivning

Date Informed Consent Signed

Datatyp

date

Måttenheter
  • Month Day Year
Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985782
Month Day Year
Projected Start Date of Treatment (Study Drug Month Day Year)
Beskrivning

ProjectedTreatmentBeginDate

Datatyp

date

Person Completing Form Last Name
Beskrivning

PersonCompletingForm,LastName

Datatyp

text

Person Completing Form First Name
Beskrivning

PersonCompletingForm,FirstName

Datatyp

text

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

PersonCompletingForm,Phone

Datatyp

text

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

PersonCompletingForm,Fax

Datatyp

float

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

PatientName

Datatyp

text

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

PatientBirthDate

Datatyp

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)
Beskrivning

Patient'sSocialSecurityNumber

Datatyp

text

Race Categories
Beskrivning

RaceCategories

Datatyp

text

Ethnic Categories
Beskrivning

EthnicCategories

Datatyp

text

Method of Payment
Beskrivning

PaymentMethod

Datatyp

text

Country of Residence (if not USA)
Beskrivning

PatientAddress,Country

Datatyp

text

Other
Beskrivning

OtherInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
Patient's zip code (USA)
Beskrivning

Patient's zip code (USA)

Datatyp

text

Patient data
Beskrivning

Patient data

Performance Status
Beskrivning

PerformanceStatus

Datatyp

integer

Alias
UMLS CUI-1
C0206065
Age at Registration
Beskrivning

PatientRegistrationAgeYearCount

Datatyp

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25646
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI-1
C0001779
Patient Height (cm)
Beskrivning

Patient Height (cm)

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0030705
UMLS CUI-2
C0489786
Patient Weight
Beskrivning

Patient Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI-1
C0005910
kg
WBC
Beskrivning

WBC

Datatyp

float

Alias
UMLS CUI-1
C0023508
SGOT (AST)
Beskrivning

SGOT (AST)

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0201899
Total bilirubin
Beskrivning

Total bilirubin

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0201913
Alkaline phosphatase
Beskrivning

Alkaline phosphatase

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0201850
Serum creatinine
Beskrivning

Serum creatinine

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0201976
Eligibility Checklist
Beskrivning

Eligibility Checklist

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

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

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
UMLS CUI-1
C0013893
Verification of Postmenopausal Status (Select the item that best describes the patient.)
Beskrivning

VerificationofPostmenopausalStatus

Datatyp

integer

Alias
NCI Thesaurus Property
C38008
NCI Thesaurus Property-2
C3231
NCI Thesaurus ObjectClass
C25171
UMLS CUI-1
C2911173
Date of Last Surgery for Breast Cancer Treatment (Must be within 84 days of randomization)
Beskrivning

DateofLastSurgeryforBreastCancerTreatment

Datatyp

date

Måttenheter
  • Month Day Year
Month Day Year
Surgical Treatment And Pathology
Beskrivning

Surgical Treatment And Pathology

Did the patient undergo lumpectomy?
Beskrivning

Didthepatientundergolumpectomy?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0851238
Was the patient diagnosed with invasive or microinvasive breast cancer?
Beskrivning

MicroinvasiveCancerInd

Datatyp

boolean

Alias
UMLS CUI-1
C0853879
Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
Beskrivning

DCISInd

Datatyp

boolean

Alias
NCI Thesaurus Property
C25458
NCI Thesaurus ObjectClass
C2924
NCI Thesaurus Property-2
C25527
UMLS CUI-1
C0007124
Are the final margins of the resected specimen histologically free of DCIS?
Beskrivning

ArethefinalmarginsoftheresectedspecimenhistologicallyfreeofDCIS?

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25508
NCI Thesaurus ObjectClass-2
C25563
NCI Thesaurus Property
C25547
NCI Thesaurus Property-2
C25527
NCI Thesaurus ValueDomain
C25180
Were there any clinically or mammographically suspicious masses or clusters of calcification?
Beskrivning

Werethereanyclinicallyormammographicallysuspiciousmassesorclustersofcalcification?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
Beskrivning

If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
If item 5a is yes, are the margins histologically free of DCIS?
Beskrivning

Ifitem6aisyes,arethemarginshistologicallyfreeofDCIS?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
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])
Beskrivning

Aretheresuspiciouspalpablenodesintheipsilateralorcontralateralaxilla?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0024204
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
Beskrivning

Aretherepalpablesupraclavicularorinfraclavicularnodes?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0241306
UMLS CUI-2
C0229743
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])
Beskrivning

Isthereabilateralmalignancyoramassormammographicabnormalityintheoppositebreastthatissuspiciousformalignancy?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0677861
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
Beskrivning

Didthepatienthaveoneormoreipsilateralaxillarynodesorintramammarynodesthatwerepositivefortumoronhistologicexamination?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0746319
UMLS CUI-2
C0441989
Did the patient undergo mastectomy?
Beskrivning

Didthepatientundergomastectomy?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0024881
Other Treatment
Beskrivning

Other Treatment

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

HassystemicorradiationtherapybeengivenforthecurrentDCIS?

Datatyp

boolean

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

PriorHormonalTherapyInd

Datatyp

boolean

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.])
Beskrivning

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

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0732611
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])
Beskrivning

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

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
If item 14 is yes, was this therapy discontinued prior to randomization?
Beskrivning

Ifitem15isyes,wasthistherapydiscontinuedpriortorandomization?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Contraindications
Beskrivning

Contraindications

Has the patient ever been diagnosed with a non-breast malignancy?
Beskrivning

Hasthepatienteverbeendiagnosedwithanon-breastmalignancy?

Datatyp

boolean

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

Ifitem17isyes,hasthepatientbeendisease-freeforatleast5years?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
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 contralateral breast
Beskrivning

Ifitem17aisno,wasthediagnosissquamousorbasalcellcarcinomaoftheskinwhichwaseffectivelytreated,carcinomainsituofthecervixthathasbeentreatedbysurgeryalone,orlobularcarcinomainsitu(LCIS)oftheipsilateralorcontralatera

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
Beskrivning

PatientTransientIschemicAttackCerebrovascularAccidentPersonalMedicalHistoryInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C29867
NCI Thesaurus Property
C50781
NCI Thesaurus Property-2
C3390
NCI Thesaurus Property-3
C18772
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0007787
UMLS CUI-2
C0038454
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?
Beskrivning

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

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0442893
UMLS CUI-2
C1518371
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
Beskrivning

Doesthepatienthaveapsychiatricoraddictivedisorderwhichwouldprecludeobtaininginformedconsent?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0004936
Does the patient have a prior history of invasive breast cancer or DCIS?
Beskrivning

DoesthepatienthaveapriorhistoryofinvasivebreastcancerorDCIS?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Does the patient have uncontrolled hypertension?
Beskrivning

Doesthepatienthaveuncontrolledhypertension?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1868885
Does the patient have uncontrolled diabetes?
Beskrivning

Doesthepatienthaveuncontrolleddiabetes?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0743131
Does the patient have atrial fibrillation, not controlled by medication?
Beskrivning

Doesthepatienthaveatrialfibrillation,notcontrolledbymedication?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0004238
Pre-entry Studies
Beskrivning

Pre-entry Studies

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

Hasthepatienthadahistoryandphysicalinthelast6months?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Has the patient had a bilateral mammogram within the past 12 months?
Beskrivning

Hasthepatienthadabilateralmammogramwithinthepast12months?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0024671
UMLS CUI-2
C3843288
Has the patient had a hysterectomy?
Beskrivning

HysterectomyPerformedInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15256
UMLS CUI-1
C0020699
If item 26 is no, has the patient had a pelvic exam within the past 12 months?
Beskrivning

Ifitem27isno,hasthepatienthadapelvicexamwithinthepast12months?

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1320722 (UMLS CUI-1)
PatientStudyID
Item
Patient Study ID
text
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
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
date
C25164 (NCI Thesaurus ValueDomain)
C2985782 (UMLS CUI-1)
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
float
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
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
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
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-2)
C1522602 (UMLS 2011AA ValueDomain-2)
PatientAddress,PostalCode
Item
Patient's zip code (USA)
text
Item Group
Item
Performance Status
integer
C0206065 (UMLS CUI-1)
CL.5
Code List
Performance Status
CL Item
Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100) (0)
CL Item
Restricted in physically strenous activity but ambulatory (K 70-80) (1)
CL Item
Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60) (2)
CL Item
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40) (3)
CL Item
Completely disabled (K 10-20) (4)
Age
Item
Age at Registration
integer
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0001779 (UMLS CUI-1)
PatientHeight
Item
Patient Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0030705 (UMLS CUI-1)
C0489786 (UMLS CUI-2)
PatientWeight
Item
Patient Weight
float
C0005910 (UMLS CUI-1)
WBC
Item
WBC
float
C0023508 (UMLS CUI-1)
SGOT (AST)
Item
SGOT (AST)
float
C25180 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI-1)
Totalbilirubin
Item
Total bilirubin
float
C25180 (NCI Thesaurus ValueDomain)
C0201913 (UMLS CUI-1)
AlkalinePhosphatase
Item
Alkaline phosphatase
float
C25180 (NCI Thesaurus ValueDomain)
C0201850 (UMLS CUI-1)
Serumcreatinine
Item
Serum creatinine
float
C25180 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI-1)
Item Group
Eligibility Checklist
PatientEligibilityInd
Item
In the opinion of the investigator, is the patient eligible?
boolean
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS CUI-1)
Item
Verification of Postmenopausal Status (Select the item that best describes the patient.)
integer
C38008 (NCI Thesaurus Property)
C3231 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus ObjectClass)
C2911173 (UMLS CUI-1)
CL.7
Code List
Verification of Postmenopausal Status (Select the item that best describes the patient.)
CL Item
Bilateral Oophorectomy (1)
CL Item
No Bilateral Oophorectomy And No Hysterectomy: And > 12 Months Since LMP (2)
CL Item
Hysterectomy But No Bilateral Oophorectomy: And Age at least 55 At Randomization (3)
CL Item
Hysterectomy But No Bilateral Oophorectomy: And Age below 55 At Randomization And FSH Within The Postmenopausal Range As Determined By The Investigator (4)
CL Item
None Of The Above (ineligible) (5)
Date of Last Surgery for Breast Cancer Treatment
Item
Date of Last Surgery for Breast Cancer Treatment (Must be within 84 days of randomization)
date
Item Group
Surgical Treatment And Pathology
Lumpectomy
Item
Did the patient undergo lumpectomy?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0851238 (UMLS CUI-1)
Invasive breast cancer
Item
Was the patient diagnosed with invasive or microinvasive breast cancer?
boolean
C0853879 (UMLS CUI-1)
DCIS
Item
Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
boolean
C25458 (NCI Thesaurus Property)
C2924 (NCI Thesaurus ObjectClass)
C25527 (NCI Thesaurus Property-2)
C0007124 (UMLS CUI-1)
Margins free of DCIS
Item
Are the final margins of the resected specimen histologically free of DCIS?
boolean
C25508 (NCI Thesaurus ObjectClass)
C25563 (NCI Thesaurus ObjectClass-2)
C25547 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property-2)
C25180 (NCI Thesaurus ValueDomain)
Suspicious masses
Item
Were there any clinically or mammographically suspicious masses or clusters of calcification?
boolean
C25180 (NCI Thesaurus ValueDomain)
Biopsy of suspicious masses
Item
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
boolean
C25180 (NCI Thesaurus ValueDomain)
Margins free of DCIS
Item
If item 5a is yes, are the margins histologically free of DCIS?
boolean
C25180 (NCI Thesaurus ValueDomain)
lymph nodes
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])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0024204 (UMLS CUI-1)
Lymph nodes palpable supraclavicular or infraclavicular
Item
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0241306 (UMLS CUI-1)
C0229743 (UMLS CUI-2)
Bilateral Malignancy
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])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0677861 (UMLS CUI-1)
Lymph node positive ipsilateral
Item
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0746319 (UMLS CUI-1)
C0441989 (UMLS CUI-2)
Mastectomy
Item
Did the patient undergo mastectomy?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0024881 (UMLS CUI-1)
Item Group
Other Treatment
Systemic or radiation therapy
Item
Has systemic or radiation therapy been given for the current DCIS?
boolean
C25180 (NCI Thesaurus ValueDomain)
Prior Hormonal Therapy
Item
Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?
boolean
Selective Estrogen Receptor Modulators (SERM)
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.])
boolean
C25180 (NCI Thesaurus ValueDomain)
C0732611 (UMLS CUI-1)
Sex hormonal therapy
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])
boolean
C25180 (NCI Thesaurus ValueDomain)
Therapy discontinued prior to randomization
Item
If item 14 is yes, was this therapy discontinued prior to randomization?
boolean
C25180 (NCI Thesaurus ValueDomain)
Item Group
Contraindications
Non-breast malignancy
Item
Has the patient ever been diagnosed with a non-breast malignancy?
boolean
C25180 (NCI Thesaurus ValueDomain)
Disease-free for at least 5 years
Item
If item 16 is yes, has the patient been disease-free for at least 5 years?
boolean
C25180 (NCI Thesaurus ValueDomain)
Skin carcinoma, cervix carcinoma or LCIS
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 contralateral breast
boolean
C25180 (NCI Thesaurus ValueDomain)
TIA or cerebrovascular accident
Item
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
boolean
C29867 (NCI Thesaurus ObjectClass)
C50781 (NCI Thesaurus Property)
C3390 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0007787 (UMLS CUI-1)
C0038454 (UMLS CUI-2)
Systemic disease, non-malignant
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?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0442893 (UMLS CUI-1)
C1518371 (UMLS CUI-2)
Psychiatric disorders
Item
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0004936 (UMLS CUI-1)
Prior history of invasive breast cancer or DCIS
Item
Does the patient have a prior history of invasive breast cancer or DCIS?
boolean
C25180 (NCI Thesaurus ValueDomain)
Hypertension, uncontrolled
Item
Does the patient have uncontrolled hypertension?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1868885 (UMLS CUI-1)
Diabetes mellitus uncontrolled
Item
Does the patient have uncontrolled diabetes?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0743131 (UMLS CUI-1)
Atrial fibrillation
Item
Does the patient have atrial fibrillation, not controlled by medication?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0004238 (UMLS CUI-1)
Item Group
Pre-entry Studies
History and physical past 6 months
Item
Has the patient had a history and physical in the last 6 months?
boolean
C25180 (NCI Thesaurus ValueDomain)
Mammogram past 12 months
Item
Has the patient had a bilateral mammogram within the past 12 months?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0024671 (UMLS CUI-1)
C3843288 (UMLS CUI-2)
Hysterectomy
Item
Has the patient had a hysterectomy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS CUI-1)
Pelvic exam past 12 months
Item
If item 26 is no, has the patient had a pelvic exam within the past 12 months?
boolean
C25180 (NCI Thesaurus ValueDomain)
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