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  1. StudyEvent: NCIC MA.32 Eligibility Worksheet
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Institution Number
Item
Institution Code
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Hospital Number (if permitted by REB)
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Item
Method of Payment
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)
Code List
Method of Payment
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Sponsored (Veterans Sponsored)
PersonAddressPostalCode
Item
Zip code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item Group
Patient Characteristics
Item
Patient Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
Code List
Patient Race
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)
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)
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)
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)
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)
CL Item
Not Provided Or Available (Not Reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Patient Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
Code List
Patient Ethnicity
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)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Eligibility Criteria
InvasiveBreastCarcinomaHistologicallyConfirmedInd-2
Item
Subject has histologically confirmed invasive breast cancer that has been diagnosed and completely resected within 12 months prior to randomization
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25527 (NCI Thesaurus ObjectClass-3)
C0205462 (UMLS 2011AA ObjectClass-3)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
Code List
Tumor Laterality
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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)
Code List
Histologic Type
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
Item
Most extensive definitive surgery
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Most extensive definitive surgery
CL Item
Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy NOS)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Is invasive cancer at margin?
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41227 (NCI Thesaurus Property-2)
C0229985 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Is invasive cancer at margin?
CL Item
Involved, Nos (Involved NOS)
CL Item
Not Involved, Nos (Not involved NOS)
DCISDiagnosisInd-3
Item
Is DCIS present? (at resection margin)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
AdjuvantRadiationTherapyAdministeredInd-3
Item
Has the subject received adjuvant radiotherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RadiationTherapyBoostAdministeredind-2
Item
Was a boost given? (to the site of residual ductal in situ disease)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25438 (NCI Thesaurus Property-2)
C1511253 (UMLS 2011AA Property-2)
Item
If neoadjuvant, subject has no evidence of clinical T4 disease prior to chemotherapy and surgery
text
C16960 (NCI Thesaurus ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C2991 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C49486 (NCI Thesaurus ValueDomain)
Code List
If neoadjuvant, subject has no evidence of clinical T4 disease prior to chemotherapy and surgery
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
T Stage, Clinical
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)
Code List
T Stage, Clinical
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 (T4)
Item
N Stage, Clinical
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)
Code List
N Stage, Clinical
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 Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2)
CL Item
Metastasis In Ipsilateral Infraclavicular Lymph Node(s) With Or Without Axillary Lymph Node Involvement, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) And In The Presence Of Clinically Evident Axillary Lymph Node Metastasis; Or, Me (N3)
Item
M Stage, Clinical
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)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
M Stage, Clinical
CL Item
No Distant Metastases (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
T1-3 and M0
Item
Subject's TNM Stage (AJCC Version 6) is one of pT1, pT2, pT3; pN0, pN1, pN2, pN3; M0 and subject has one of the pT pN combinations described in protocol section 5.1.4 and subject has sentinel node biopsy and/or full axillary lymph node dissection
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C25384 (NCI Thesaurus Property-2)
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic T Stage
CL Item
No Evidence Of Primary Tumor (T0)
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (T1a)
CL Item
Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (T1b)
CL Item
Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (T1c)
CL Item
Microinvasion 0.1 Cm Or Less In Greatest Dimension (T1mic)
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 (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)
CL Item
Inflammatory Carcinoma (T4d)
C0334385 (NCI Metathesaurus)
CL Item
Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (Tis)
CL Item
Ductal Carcinoma In Situ (Tis (DCIS))
CL Item
Lobular Carcinoma In Situ (Tis (LCIS))
CL Item
Paget's Disease Of The Nipple With No Tumor. [note: Paget's Disease Associated With A Tumor Is Classified According To The Size Of The Tumor.] (Tis (Paget's))
CL Item
Primary Tumor Cannot Be Assessed (TX)
Item
Pathologic N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic N Stage
CL Item
No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)
CL Item
No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (pN0(i+))
CL Item
No Regional Lymph Node Metastasis Histologically, Negative Ihc (pN0(i-))
CL Item
No Regionally Lymph Node Metastasis Histologically, Positive Molecular Findings (rt-pcr) (pN0(mol+))
CL Item
No Regional Lymph Node Metastasis Histologically, Negative Molecular Findings (rt-pcr) (pN0(mol-))
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes, And/or In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)
CL Item
Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)
CL Item
Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes, Or In Clinically Apparent ** Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To Each Other Or To Other Structures (pN2)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)
CL Item
Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)
CL Item
Metastasis In >= Axillary Lymph Nodes, Or In Infraclavicular Lymph Nodes, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) In The Presence Of 1 Or More Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes With Clinically N (pN3)
CL Item
Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)
CL Item
Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)
CL Item
Metastasis In Ipsilateral Supraclavicular Lymph Nodes (pN3c)
CL Item
Regional Lymph Nodes Cannot Be Assessed (e.g., Not Removed For Pathologic Study Or Previously Removed) (pNX)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
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)
Code List
Histologic Grade
CL Item
G1 Low Combined Histologic Grade (favorable) (G1)
CL Item
G2 Intermediate Combined Histologic Grade (moderately Favorable) (G2)
CL Item
G3 High Combined Histologic Grade (unfavorable) (G3)
CL Item
Gx Grade Cannot Be Assessed (GX)
Item
Is there lymphovascular invasion?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
C25561 (NCI Thesaurus Property-2)
C1518090 (UMLS 2011AA Property-2)
Code List
Is there lymphovascular invasion?
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
Item
Oncotype DX Recurrence Score
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTumorMarkerKi-67AntigenResultValue
Item
Ki67 Score
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property-2)
C0041365 (UMLS 2011AA Property-2)
C17675 (NCI Thesaurus Property-3)
C0208804 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodePositiveAssessmentCount
Item
Number of Positive Sentinel Nodes
float
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
AxillaryNodeDissectionInd-3
Item
Was axillary dissection performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
Date of Axillary Node Biopsy
Item
Date of Axillary Node Biopsy
date
C15680 (NCI Thesaurus ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C15206 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0193842 (UMLS CUI-1)
C0729594 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
AxillaryNodeExaminedTotalCount
Item
Number of axillary nodes examined
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
PositiveAxillaryNodeExaminedTotalCount
Item
Number of positive axillary nodes
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
If subject has bilateral breast carcinoma diagnoses were synchronous - within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither meets the exclusion criteria
text
C16960 (NCI Thesaurus ObjectClass)
C13332 (NCI Thesaurus Property)
C4872 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C49486 (NCI Thesaurus ValueDomain)
C0238767 (UMLS CUI-1)
C0678222 (UMLS CUI-2)
Code List
If subject has bilateral breast carcinoma diagnoses were synchronous - within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither meets the exclusion criteria
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Chemotherapy, if given, has been completed at least 4 weeks prior to randomization
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy, if given, has been completed at least 4 weeks prior to randomization
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PriorAdjuvantChemotherapyAdministeredInd-2
Item
Prior Adjuvant Chemotherapy
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdjuvantChemotherapyPriorEndDate
Item
Date Prior Adjuvant Chemotherapy Ended
date
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Known estrogen/progesterone receptor status
Item
Estrogen/progesterone receptor status is known
boolean
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C16149 (NCI Thesaurus Property-2)
C16150 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1514471 (UMLS CUI-1)
C1516974 (UMLS CUI-2)
Item
Receptor Status, ER
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)
Code List
Receptor Status, ER
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
Receptor Status, PgR
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Code List
Receptor Status, PgR
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientHER2/neuEligibilityDeterminationInd-2
Item
HER2 status is known
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
Item
HER-2/neu status
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)
Code List
HER-2/neu status
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
HER2 test type
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C71460 (NCI Thesaurus Property)
C0025663 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus Property-3)
C0449438 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
HER2 test type
CL Item
Immunohistochemistry Staining Method (IHC)
C23020 (NCI Thesaurus)
C0021044 (UMLS 2011AA)
CL Item
Fluorescence In Situ Hybridization (FISH)
C17563 (NCI Thesaurus)
C0162789 (UMLS 2011AA)
CL Item
Chromogenic In Situ Hybridization (CISH)
C40960 (NCI Thesaurus)
C1516514 (UMLS 2011AA)
CL Item
Other (Other)
LaboratoryProcedureHER2/neuStatusMethodSpecify
Item
Specify (If other,)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C71460 (NCI Thesaurus Property)
C0025663 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus Property-3)
C0449438 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientBilateralMammogramEligibilityDeterminationInd-2
Item
Subject has had a bilateral mammogram within 12 months prior to randomization
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20178 (NCI Thesaurus Property)
C0024671 (UMLS 2011AA Property)
C13332 (NCI Thesaurus Property-2)
C0238767 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MammogramPerformedDate
Item
Date of mammogram
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
ECOG 0,1,2
Item
Subject has ECOG Performance Status of 0, 1 or 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1512162 (UMLS CUI-1)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status
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)
PatientAgeEligibilityDeterminationInd-2
Item
Subject is < 75 years of age and has life expectancy of at least 5 years
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Birth date
Item
Patient date of birth
date
C25164 (NCI Thesaurus ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
Patient available for treatment and follow-up
Item
Subject is accessible for treatment and follow-up
boolean
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
TherapyBeginRequirementInd-2
Item
Protocol treatment will begin within 10 working days after randomization
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C38015 (NCI Thesaurus Property-2)
InformedConsentFormSignedInd-2
Item
Most recent REB approved informed consent has been signed according to local institutional requirements
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientCorrelativeStudySpecimenConsentInd-3
Item
Most recent REB approved Tissue and Blood Collection and Banking informed consent has been signed and dated by the patient and appropriate "I agree/I don't agree" box has been checked
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)
PatientCorrelativeStudySpecimenConsentDate
Item
Date tissue and blood collection and banking consent signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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)
PatientCorrelativeStudySpecimenConsentVersionDate
Item
Tissue and blood collection and banking consent version date
text
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)
English or French speaking
Item
Is the subject English or French speaking
boolean
C16960 (NCI Thesaurus ObjectClass)
C43853 (NCI Thesaurus Property)
C16779 (NCI Thesaurus Property-2)
C43854 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0745640 (UMLS CUI-1)
C0376246 (UMLS CUI-2)
Item
Subject has completed the baseline Quality of Life questionnaire and is willing to complete future assessments
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C25369 (NCI Thesaurus Property-3)
C0680240 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Subject has completed the baseline Quality of Life questionnaire and is willing to complete future assessments
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No, The Questionnaire Was Not Completed But For Reason(s) That Do Not Affect Eligibility (No, the questionnaire was not completed but for reason(s) that do not affect eligibility)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
Item
Reason questionnaire was not completed
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
Code List
Reason questionnaire was not completed
CL Item
Illiteracy In English (Illiteracy in English)
CL Item
Loss Of Sight (Loss of sight)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientIncompleteQuestionnaireOtherSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
PatientEnglishLanguageEligibilityDeterminationInd-2
Item
Is the subject English speaking and has s/he already completed the Quality of Life questionnaire
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C82847 (NCI Thesaurus Property)
C0376245 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Item
Subject has completed the baseline Nurses Health Study II Physical Activity Questionnaire and the Block Alive Screener and is willing to complete future assessments
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass-2)
Code List
Subject has completed the baseline Nurses Health Study II Physical Activity Questionnaire and the Block Alive Screener and is willing to complete future assessments
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No, The Questionnaire Was Not Completed But For Reason(s) That Do Not Affect Eligibility (No, the questionnaire was not completed but for reason(s) that do not affect eligibility)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AdditionalFormCompleteDate
Item
Date patient filled out questionnaires
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass-2)
Investigations within 4 weeks to surgery
Item
Investigations, including chest X-ray or CT chest, bone scan and abdominal have been performed no earlier than 4 weeks prior to primary surgery and no later than the date of randomization and are negative for metastases
boolean
C25294 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C49236 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
ChestX-RayAssessmentDate
Item
Date of Chest X-ray
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass-2)
Date of CT or MRI of chest
Item
Date of CT or MRI of chest
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C25389 (NCI Thesaurus ObjectClass-3)
C16809 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0817096 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0024485 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
BoneScanMedicalImagingAssessmentDate
Item
Date of bone scan
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)
BoneX-RayAssessmentDate
Item
Date of bone x-rays
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass-2)
Date Abdominal CT or MRI
Item
Date Abdominal CT or MRI
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C12664 (NCI Thesaurus ObjectClass-3)
C16809 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0230168 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0024485 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
Date of liver CT or US scan
Item
Date of liver CT or US scan
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C12392 (NCI Thesaurus ObjectClass-3)
C17230 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0023884 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0041618 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
Abdominal ultrasound date
Item
Abdominal ultrasound date
date
C16502 (NCI Thesaurus ObjectClass)
C12664 (NCI Thesaurus ObjectClass-2)
C17230 (NCI Thesaurus ObjectClass-3)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C2348813 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item Group
Eligibility Labs
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI [1])
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Platelets
Item
Peripheral Platelet Count
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI [1])
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0023508 (UMLS CUI [1])
Granulocyte count
Item
Granulocytes
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
MCV
Item
Mean Corpuscular Volume
float
C16673 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C64799 (NCI Thesaurus Property-2)
C0524587 (UMLS CUI-1)
AST
Item
AST (SGOT)
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1])
Creatinine, serum ULN
Item
Serum 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)
Bilirubin, total
Item
Bilirubin, total
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1])
Item Group
Ineligibility Criteria
Fasting glucose
Item
Fasting glucose
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C41376 (NCI Thesaurus Property-2)
C63663 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0202045 (UMLS CUI-1)
Item
Pregnancy Test 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)
Code List
Pregnancy Test Result
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Not Applicable, Not Female Of Child-bearing Potential (not applicable, not female of child-bearing potential)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Evaluated (not evaluated)
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)
Item Group
Physical Exam
History and physical examination date
Item
Date of Pre-entry History & Physical Exam
date
C25164 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C18772 (NCI Thesaurus ObjectClass-2)
C0150618 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16358 (NCI Thesaurus Property)
C16358 (NCI Thesaurus ValueDomain-2)
C1305855 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C25337 (NCI Thesaurus ValueDomain)
C25209 (NCI Thesaurus Property)
C0332520 (NCI Metathesaurus ObjectClass)
C64192 (NCI Thesaurus ObjectClass)
C0455829 (UMLS CUI-1)
HipCircumferenceMeasurementNumbers3NoDecimal
Item
Hip Circumference
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C0019552 (NCI Metathesaurus ObjectClass)
C0332520 (NCI Metathesaurus ObjectClass-2)
Systolic blood pressure
Item
Systolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS CUI [1])
LastMenstrualCycleOccurrenceDate
Item
Date of last menstrual period
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass-2)
C0025329 (UMLS 2011AA ObjectClass-2)
Item
Menopausal Status
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain-2)
C0025320 (UMLS 2011AA ValueDomain-2)
Code List
Menopausal Status
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (<6 mo since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement))
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy))
CL Item
Above Categories Not Applicable And Age <50 (Above categories not applicable AND Age < 50)
CL Item
Above Categories Not Applicable And Age >= 50 (Above categories not applicable AND Age >= 50)
Item Group
Stratification
Item
Hormonal status
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C28154 (NCI Thesaurus Property)
C0019929 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Code List
Hormonal status
CL Item
Er-positive And/or Pgr-positive (ER-positive and/or PgR-positive)
CL Item
Er-negative And Pgr Negative (neither Tamoxifen Nor Aromatase Inhibitor Is Permitted)) (ER-negative and PgR negative (neither tamoxifen nor aromatase inhibitor is permitted)))
Item
Body Mass Index
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16358 (NCI Thesaurus Property)
C1305855 (UMLS 2011AA Property)
Code List
Body Mass Index
CL Item
<=30 (<=30)
CL Item
>30 (>30)
Item Group
Consent
ParticipatingPatientAncillaryStudyConsentInd-2
Item
Has this subject given written consent to participate in MA.32F
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus ObjectClass-2)
C0679823 (UMLS 2011AA ObjectClass-2)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL004903 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ConsentFormPatientResponsiblePersonSignedInd-2
Item
Has informed consent been signed and dated by patient and person conducting consent form discussion
boolean
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25657 (NCI Thesaurus Property-2)
C1273518 (UMLS 2011AA Property-2)
C25679 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Consent form language
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16779 (NCI Thesaurus Property)
C0023008 (UMLS 2011AA Property)
Code List
Consent form language
CL Item
English Language (English)
C82847 (NCI Thesaurus)
C0376245 (UMLS 2011AA)
CL Item
French Language Other (French or Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C16779 (NCI Thesaurus-3)
C0023008 (UMLS 2011AA-4)
C43854 (NCI Thesaurus-5)
C1556084 (UMLS 2011AA-6)
InformedConsentFormVersionSignedDate
Item
Consent form version date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C25714 (NCI Thesaurus Property-2)
C0333052 (UMLS 2011AA Property)
ConsentFormPatientVersionSignedDate
Item
Date signed by patient
date
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25679 (NCI Thesaurus Property-2)
C25714 (NCI Thesaurus Property-3)
C0333052 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ConsentFormPatientResponsiblePersonSignedName
Item
Name of person conducting the consent form discussion
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25657 (NCI Thesaurus Property-2)
C1273518 (UMLS 2011AA Property-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property-3)
Investigator Signature Date
Item
Date of 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)

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