ID

11817

Beschrijving

NCIC MA.32 Eligibility Worksheet A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer NCT01101438 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80D63865-BE43-3FAC-E040-BB89AD4349FC

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80D63865-BE43-3FAC-E040-BB89AD4349FC

Trefwoorden

Clinical Trial

Behandlungsbedürftigkeit, Begutachtung

Breast Neoplasms

Geüploaded op

4 augustus 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Eligibility Breast Cancer early stage NCIC MA.32 NCT01101438

model
Details

No Instruction available.

1 Formulieren

StudyEvent: NCIC MA.32 Eligibility Worksheet
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header Module

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)

PatientPaymentType

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)

CL.3

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)

PATIENT CHARACTERISTICS

Item Group

Patient Characteristics

Racial Group

Item

Patient Race

text

C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)

CL.1

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)

Ethnic Group

Item

Patient Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)

CL.2

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)

ELIGIBILITY CRITERIA

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)

PrimaryTumorLateralityType

Item

Tumor Laterality

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.5

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)

BreastTumorHistologicCategory

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)

CL.6

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)

BreastPrimarySurgicalProcedurePerformedType

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)

CL.7

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)

InvasiveCancerSurgicalMarginResultType

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)

CL.8

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)

no T4 if neoadjuvant

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)

CL.12

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)

BreastTumorClinicalTStage

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)

CL.13

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)

BreastTumorClinicalNStage

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)

CL.14

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)

BreastTumorClinicalMStage

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)

CL.15

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)

BreastTumorPathologicTStage

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)

CL.17

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)

BreastTumorPathologicNStage

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)

CL.18

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)

BreastTumorPathologicMStage

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)

CL.19

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)

BreastTumorHistologicGrade

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)

CL.20

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)

TumorLymphovascularInvasionInd

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)

CL.21

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)

Synchronous bilateral breast carcinoma

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)

CL.24

Code List

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)

PatientChemotherapyEligibilityDeterminationInd-4

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)

CL.25

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)

ERLevelTumorStatus

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)

CL.28

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)

PgRStatusType

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)

CL.29

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)

HER2/neuStatusType

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)

CL.53

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)

LaboratoryProcedureHER2/neuStatusMethodType

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)

CL.32

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)

ECOG Performance Status

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)

CL.36

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)

PersonQualityofLifeCompleteAgreementIndicator

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)

CL.43

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)

PatientQuestionnaireCompleteNotAdministeredReason

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)

CL.48

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)

AdditionalFormCompleteIndicator

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)

CL.47

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)

Hematology and Biochemistry

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])

Ineligibility Criteria

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)

LaboratoryProcedurePregnancyResultInd

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)

CL.49

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)

Physical Exam

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)

PatientMenopauseCategory

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)

CL.50

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)

Stratification

Item Group

Stratification

PersonHormoneReceptorStatus

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)

CL.51

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)))

PersonBodyMassIndexType

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)

CL.52

Code List

Body Mass Index

CL Item

<=30 (<=30)

CL Item

>30 (>30)

Consent

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)

ConsentFormLanguageType

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)

CL.56

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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Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Eligibility Breast Cancer early stage NCIC MA.32 NCT01101438

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