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ID
8643
Description
Z1041: Registration Worksheet Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=211E7BC7-C479-7160-E044-0003BA3F9857
Link
Keywords
Versions (6)
- 8/26/12 8/26/12 -
- 8/11/14 8/11/14 - Martin Dugas
- 1/9/15 1/9/15 - Martin Dugas
- 6/27/15 6/27/15 -
- 7/25/15 7/25/15 - Martin Dugas
- 9/20/21 9/20/21 -
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January 9, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00513292 Registration - Z1041: Registration Worksheet - 2533859v1.0
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- StudyEvent: Z1041: Registration Worksheet
Similar models
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- StudyEvent: Z1041: Registration Worksheet
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C1442488 (UMLS 2011AA)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials First
Item
First
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle
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)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Patient Initials Last
Item
Last
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
PatientRegistrationDate
Item
Registration Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Item
Has patient previously been registered to an ACOSOG study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C1514463 (UMLS 2011AA ObjectClass-2)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C1514463 (UMLS 2011AA ObjectClass-2)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Protocol ID Coordinating Group
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Birth Date
Item
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)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)
C0015780 (UMLS 2011AA)
Item
Race (Mark all that apply)
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
C0007457 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
C1513907 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
C1515945 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C0439673 (UMLS 2011AA)
Item
Ethnicity (Mark only one)
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C0439673 (UMLS 2011AA)
Item
Method of payment (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL Item
Private Insurance (Private insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and private insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or veterans sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military sponsored)
CL Item
Veterans Sponsored (Veterans sponsored)
CL Item
Self Pay (no Insurance) (Self pay)
CL Item
No Means Of Payment (no Insurance) (No means of payment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
PatientPaymentSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
PatientAddressPostalCode
Item
Patient Zip Code (USA)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CanadaAddressPostalCode
Item
Postal code (Canada)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PatientOtherCountryAddressPostalCode
Item
Other Country Postal Code (Other)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Country of current residence
Item
Country of Residence
text
C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
HIPAA Authorization form
text
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL Item
Included In Study Informed Consent (Included in Study Informed Consent)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If signed as a separate form,)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudySpecimenConsentInd-3
Item
Consent for correlative studies and specimen banking signed
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudySpecimenConsentDate
Item
Date signed (If yes,)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Inclusion Criteria
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0027361 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Alkaline Phosphatase Must Be <= 2.5 X Uln For The Lab (Alkaline phosphatase must be <= 2.5 x ULN for the lab)
CL Item
Anc Must Be <= 1200/mm^3 (ANC must be <= 1200/mm^3)
CL Item
Ast Must Be <= 1.5 X Uln For The Lab (AST must be <= 1.5 x ULN for the lab)
CL Item
Breast Cancer Must Be Determined To Be Her2-positive Prior To Study Entry (Breast cancer must be determined to be HER2-positive prior to study entry)
CL Item
Breast Tumor Must Be Palpable And Measure >= 2 Cm According To Recist Criterion (Breast tumor must be palpable and measure >= 2 cm according to RECIST criterion)
CL Item
Diagnosis Of Invasive Adenocarcinoma Of Breast Must Have Been Made By Core Needle Biopsy (Diagnosis of invasive adenocarcinoma of breast must have been made by core needle biopsy)
CL Item
If Patient Had Skeletal Pain Or Alkaline Phosphatase > Uln But <= 2.5 X Uln, Bone Scan Must Show No Metastatic Disease (If patient had skeletal pain or alkaline phosphatase > ULN but <= 2.5 x ULN, bone scan must show NO metastatic disease)
CL Item
Patient Must Be Female And 18 Years Of Age Or Older (Patient must be female and 18 years of age or older)
CL Item
Patient Must Have An Ecog/ Zubrod Performance Status Of <= 1 (Patient must have an ECOG/ Zubrod performance status of <= 1)
CL Item
Platelet Count Must Be >=100,000 /mm^3 (Platelet count must be >=100,000/mm^3)
CL Item
Serum Creatinine Must Be <= Uln For The Lab (Serum creatinine must be <= ULN for the lab)
CL Item
Total Bilirubin Must Be <= Uln For The Lab (Total bilirubin must be <= ULN for the lab)
CL Item
Within 3 Months Prior To Study Entry, Patient Must Have A Baseline Left Ventricular Ejection Fraction (lvef) Measured By Muga Scan >= 55 (Within 3 months prior to study entry, patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan >= 55)
Item
Exclusion Criteria
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0027361 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Patient Had Prior Therapy With Anthracyclines Or Taxanes For Any Malignancy (Patient had prior therapy with anthracyclines or taxanes for any malignancy)
CL Item
Patient Has Cardiac Disease That Would Preclude The Use Of Epirubicin Or Trastuzumab (Patient has cardiac disease that would preclude the use of epirubicin or trastuzumab)
CL Item
Patient Has Definitive Clinical Or Radiological Evidence Of Metastatic Disease (Patient has definitive clinical or radiological evidence of metastatic disease)
CL Item
Patient Has Had Administration Of Any Investigational Agents Within 30 Days Prior To Study Entry (Patient has had administration of any investigational agents within 30 days prior to study entry)
CL Item
Patient Has Had Surgical Axillary Staging Procedure Prior To Study Entry (excluding Fna Of Axillary Nodes) (Patient has had surgical axillary staging procedure prior to study entry (excluding FNA of axillary nodes))
CL Item
Patient Has History Of Ipsilateral Dcis Treated With Radiation Therapy (Patient has history of ipsilateral DCIS treated with radiation therapy)
CL Item
Patient Has Ipsilateral Cn2b Or Cn3 Disease (Patient has ipsilateral cN2b or cN3 disease)
CL Item
Patient Has Non-malignant Systemic Disease That Would Preclude Treatment With Either Regimen (Patient has non-malignant systemic disease that would preclude treatment with either regimen)
CL Item
Patient Has Prior History Of Invasive Breast Cancer (Patient has prior history of invasive breast cancer)
CL Item
Patient Has Psychiatric Or Addictive Disorder Or Any Other Condition That, In The Investigator?s Opinion, Precludes Patient From Meeting Eligibility Requirements (Patient has psychiatric or addictive disorder or any other condition that, in the investigator?s opinion, precludes patient from meeting eligibility requirements)
CL Item
Patient Has Sensory/ Motor Neuropathy >= Grade 2 As Defined By Ctcae V3.0 (Patient has sensory/ motor neuropathy >= grade 2 as defined by CTCAE v3.0)
CL Item
Patient Has Synchronous Invasive Breast Cancer (Patient has synchronous invasive breast cancer)
CL Item
Patient Has Tumor Clinically Staged As T4 (Patient has tumor clinically staged as T4)
CL Item
Patient Is Receiving Therapy With Any Hormonal Agent (excluding Medication Discontinued Before Study Entry) (Patient is receiving therapy with ANY hormonal agent (excluding medication discontinued before study entry))
CL Item
Patient Of Child-bearing Potential Does Not Have Negative Urine/ Serum Pregnancy Test Within 2 Weeks Of Registration Or Patient Is Breast Feeding (Patient of child-bearing potential does not have negative urine/ serum pregnancy test within 2 weeks of registration or patient is breast feeding)
CL Item
Patient Received Treatment For This Breast Cancer Prior To Study Entry (excluding Hormonal Therapy That Ended Before Study Entry) (Patient received treatment for this breast cancer prior to study entry (excluding hormonal therapy that ended before study entry))
ACOSOGPatientEligibilityInd-2
Item
Patient meets all eligibility criteria
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Eligibility for trial
Item
In the opinion of the investigator, is the patient eligible?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Assessment Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Randomization (Please indicate "arm" assigned as a result of randomization:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C15538 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS 2011AA ObjectClass-2)
C0332307 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C15538 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS 2011AA ObjectClass-2)
CL Item
Neoadjuvant Treatment With Fec-75 12w, Followed By Paclitaxel And Trastuzumab, 12w, Surgery And Trastuzumab (Neoadjuvant treatment with FEC-75 12W, followed by Paclitaxel and Trastuzumab, 12W, surgery and Trastuzumab)
CL Item
Neoadjuvant Treatment With Paclitaxel 12w And Trastuzamab 13w Followed By Fec-75 And Trastuzumab, 12w, Surgery And Trastuzumab (Neoadjuvant treatment with Paclitaxel 12W and Trastuzamab 13W followed by FEC-75 and Trastuzumab, 12W, surgery and Trastuzumab)
Item
Baseline Performace Status (ECOG/modified Zubrod scale)
text
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C1442488 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL Item
Contralateral Mammogram (Contralateral mammogram)
CL Item
Ipsilateral Mammogram (Ipsilateral mammogram)
CL Item
Ipsilateral Axilla Ultrasound (Ipsilateral Axilla Ultrasound)
CL Item
Muga Scan (MUGA scan)
AssessmentMethodText
Item
Not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
DiagnosticImagingProcedureDate
Item
Image date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)
HeartLeftVentricularEjectionFractionRadionuclideVentriculogramScanAssessmentPercentageValue
Item
Left Ventricular Ejection Fraction from MUGA (LVEF)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property-2)
C0521317 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property-2)
C0521317 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLeftVentricularEjectionFractionRadionuclideVentriculogramScanAssessmentPercentageLowerLimitofNormalValue
Item
MUGA LLN (for LVEF)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property-2)
C0521317 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property-2)
C0521317 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
HeartLeftVentricularEjectionFractionEchocardiogramAssessmentPercentageValue
Item
Left Ventricular Ejection Fraction from ECHO (LVEF)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37945 (NCI Thesaurus Property-2)
C2243117 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37945 (NCI Thesaurus Property-2)
C2243117 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLeftVentricularEjectionFractionEchocardiogramAssessmentPercentageLowerLimitofNormalValue
Item
ECHO LLN (for LVEF)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37945 (NCI Thesaurus Property-2)
C2243117 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37945 (NCI Thesaurus Property-2)
C2243117 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
PregnancyTestPerformedInd-2
Item
Pregnancy test done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
Item
Reason pregnancy test not performed
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL Item
Postmenopausal (Post-menopausal)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C0232970 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
PregnancyLaboratoryProcedureNotPerformedSpecify
Item
Other, specify
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Type of pregnancy test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
CL Item
Serum (Serum)
C13325 (NCI Thesaurus)
C0229671 (UMLS 2011AA)
C0229671 (UMLS 2011AA)
CL Item
Urine (Urine)
C13283 (NCI Thesaurus)
C0042036 (UMLS 2011AA)
C0042036 (UMLS 2011AA)
PatientMostRecentPregnancyTestDate
Item
Date of pregnancy test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item
Result
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25742 (NCI Thesaurus Property-2)
C0032961 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25742 (NCI Thesaurus Property-2)
C0032961 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
C1446409 (UMLS 2011AA)
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
C0205160 (UMLS 2011AA)
Item
Method of biopsy
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
C0005558 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
CL Item
Fna (FNA)
CL Item
Core Needle Biopsy (Core needle biopsy)
Item
Receptor Status, ER (mark one)
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
C0205160 (UMLS 2011AA)
Item
Marker Test Method (mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C0332307 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
CL Item
Fluorescence In Situ Hybridization (fish) (Fluorescence in situ hybridization (FISH))
CL Item
Immunohistochemistry (ihc) (Immunohistochemistry (IHC))
Item
HER-2/neu status (mark one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
C0205160 (UMLS 2011AA)
Item
PgR Status (mark one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
C0205160 (UMLS 2011AA)
Item
Histologic Grade
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)
CL Item
Well Differentiated (Grade I (low))
CL Item
Moderately Differentiated (Grade II (intermediate))
CL Item
Poorly Differentiated (Grade III (high))
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular (pure > or =90%))
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
CL Item
Other Specify (Other)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
Item
Clinical T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL Item
No Evidence Of Primary Tumor (T0)
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (T3)
CL Item
Tumor Of Any Size With Direct Extension To (a) Chest Wall Or (b) Skin, Only As Described Below (T4)
CL Item
Extension To Chest Wall (T4a)
CL Item
Edema (including Peau D'orange) Or Ulceration Of The Skin Of The Breast Or Satellite Skin Nodules Confined To The Same Breast (T4b)
CL Item
Both T4a And T4b (T4c)
Item
Clinical N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)
CL Item
Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To One Another Or To Other Structures (N2)
CL Item
Metastasis To Ipsilateral Mammary Lymph Node(s) (N3)
Item
Is there a breast lesion >= 2 cm
text
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C49668 (NCI Thesaurus Property-2)
C0475210 (UMLS 2011AA Property-2)
C66833 (NCI Thesaurus Property-3)
C0205448 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C0678222 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C49668 (NCI Thesaurus Property-2)
C0475210 (UMLS 2011AA Property-2)
C66833 (NCI Thesaurus Property-3)
C0205448 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
No And Largest Nodal Metastasis < 2 Cm (No and largest nodal metastasis < 2 cm)
CL Item
No And Largest Nodal Metastasis >= 2 Cm (No and largest nodal metastasis >= 2 cm)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
SpecimenCollectedDate
Item
Date Specimen collected (if multiple draw dates, enter first and last)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
AssessmentMethodText
Item
Not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Neutrophil count
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets
Item
Platelet count
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
Bilirubin, Total ULN
Item
Total bilirubin (mg/dl), ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
SGOT (AST)
Item
SGOT (AST)
float
C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HepaticAlkalinePhosphataseLabValue
Item
Alkaline Phosphatase
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Creatinine, Serum
Item
Serum creatinine
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
HypertensionHistoryInd-3
Item
Hypertension
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C1512699 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item
Smoking
text
C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
CL Item
Never Smoked (Never smoked)
CL Item
Smoked In The Past (Smoked in the past)
CL Item
Currently Smoking (Currently smoking)
PatientHeartDiseasesandDisordersPersonalMedicalHistoryInd-2
Item
Cardiac Disease History
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12727 (NCI Thesaurus Property)
C0018787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C12727 (NCI Thesaurus Property)
C0018787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CardiovascularSystemDiseasesandDisordersMedicationBaselineUseInd-2
Item
Cardiovascular Disease
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C12686 (NCI Thesaurus ObjectClass-3)
C0007226 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0012634 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C12686 (NCI Thesaurus ObjectClass-3)
C0007226 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiabetesMellitusDiseasesandDisordersMedicationBaselineUseInd-2
Item
Diabetes
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus ObjectClass-2)
C0011849 (UMLS 2011AA ObjectClass-2)
C459 (NCI Thesaurus ObjectClass-3)
C0013227 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0012634 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus ObjectClass-2)
C0011849 (UMLS 2011AA ObjectClass-2)
C459 (NCI Thesaurus ObjectClass-3)
C0013227 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HyperlipidemiaDiseasesandDisordersMedicationBaselineUseInd-2
Item
Hyperlipidemia
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C34707 (NCI Thesaurus ObjectClass-3)
C0020473 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0012634 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C34707 (NCI Thesaurus ObjectClass-3)
C0020473 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorBreastCarcinomaRadiationTherapyPersonalMedicalHistoryInd-2
Item
Has the patient had a prior history of breast cancer requiring radiation
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus Property-3)
C0678222 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus Property-3)
C0678222 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Location of tumor (If yes,)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus Property-3)
C0678222 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus Property-3)
C0678222 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL Item
Left Breast: C47855 (Left Breast)
C47855 (NCI Thesaurus)
C0222601 (UMLS 2011AA)
C0222601 (UMLS 2011AA)
CL Item
Right Breast: C47856 (Right Breast)
C47856 (NCI Thesaurus)
C0222600 (UMLS 2011AA)
C0222600 (UMLS 2011AA)
CaseReportFormInvestigatorReviewInd-2
Item
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
Investigator Signature Date
Item
Date of Investigator Signature
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)
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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