ID

43303

Beschrijving

E5103 On-Study Form NCT00433511 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22AFBF9F-D69B-53CC-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22AFBF9F-D69B-53CC-E044-0003BA3F9857

Trefwoorden

Klinische Studie [Dokumenttyp]

On-Study Form

C50

Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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E5103 On-Study Form NCT00433511

model
Details

Instructions: Complete this form and submit original to the ECOG Coordinating Center within one week of registrations. Keep a copy for your files.

1 Formulieren

StudyEvent: E5103 On-Study Form
1. Instructions: Complete this form and submit original to the ECOG Coordinating Center within one week of registrations. Keep a copy for your files.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

ECOG clinical trial administrative data

Item Group

ECOG clinical trial administrative data

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Clinical Trial Period

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Reporting Period

CL Item

Baseline Step 1 (Baseline step 1)

Data amended

Item

Please mark an 'X' if data have been amended (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Patient demographics

Item Group

Patient demographics

Patient Initials

Item

Patient Initials (Last,First)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Performance status

Item Group

Performance status

ECOG Performance Status

Item

ECOG Performance Status (Day 1 of this cycle)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

Code List

ECOG Performance Status (Day 1 of this cycle)

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)

PatientMenopauseStatus

Item

Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months; or 2 age </=55 with no spontaneous menses within the past 12 months e.g., spontaneously or...)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.3

Code List

CL Item

Postmenopausal (Postmenopausal)

C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus-3)
C0232970 (UMLS 2011AA-4)
C15421 (NCI Thesaurus-5)
C0232970 (UMLS 2011AA-6)

CL Item

Premenopausal (Premenopausal)

C15491 (NCI Thesaurus)
C0279752 (UMLS 2011AA)

CL Item

Perimenopausal (Perimenopausal)

C15692 (NCI Thesaurus)
C3839366 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Pre-Registration Evaluation

Item Group

Pre-registration Evaluation

Patient Height

Item

Height

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

PriorTamoxifenAdministeredInd-3

Item

Prior tamoxifen therapy

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.4

Code List

Prior tamoxifen therapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

HormoneTherapyPriorRaloxifeneReceivedInd-3

Item

Prior raloxifene therapy? (for chemoprevention)

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1518 (NCI Thesaurus Property)
C0244404 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25639 (NCI Thesaurus Property-3)
C1514756 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.5

Code List

Prior raloxifene therapy? (for chemoprevention)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

UrinaryCreatinineProteinAssessmentValue

Item

Urine Protein/Creatinine Ratio

float

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Laboratory Procedure Date

Item

Date lab assessment performed

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Pre-Registration Scans/Imaging

Item Group

Pre-registration Scans/imaging

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.6

Code List

Method of Evaluation

CL Item

Bone Scan (Bone scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Chest Radiography (Chest CT)

C38103 (NCI Thesaurus)
C0039985 (UMLS 2011AA)

CL Item

Chest X-ray (Chest x-ray)

Assessment Date

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

AssessmentImageReportingType

Item

Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus ValueDomain-2)
C0700287 (UMLS 2011AA ValueDomain-2)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)

CL.7

Code List

Result

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Not Done (not done)

CL281691 (NCI Metathesaurus)

Disease Description

Item Group

Disease Description

PrimaryTumorLateralityType

Item

Tumor Laterality (NOTE: Submit copies of pathology reports for all diagnostic and therapeutic surgical procedures with E5103 Source Document Tracking Coversheet)

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.8

Code List

Tumor Laterality (NOTE: Submit copies of pathology reports for all diagnostic and therapeutic surgical procedures with E5103 Source Document Tracking Coversheet)

CL Item

Bilateral (Bilateral)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

Section I - Unilateral Disease - Either Side

Item Group

Breast: Surgical Procedures

BreastPrimarySurgicalProcedurePerformedType

Item

Most Extensive Primary 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.17

Code List

Most Extensive Primary 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 (m/d/y)

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)

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 (If yes: - m/d/y)

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)

SentinelNodePositiveHematoxylinandEosinStainingAssessmentCount

Item

Number of Positive Sentinel Nodes by H&E (enter '0' if no positive nodes)

float

C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C23011 (NCI Thesaurus Property-2)
C0523207 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

SentinelNodePositiveImmunohistochemistryAssessmentCount

Item

Number of Positive Sentinel Nodes by Immunohistochemistry (IHC) only (enter '0' if no positive nodes)

float

C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C16722 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

DataUnknownText

Item

Mark an 'X' if not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

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)

AxillarySurgeryDissectionDate

Item

Date of Axillary Dissection (If yes: - m/d/y)

date

C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

AxillaryNodeExaminedTotalCount

Item

Total number of axillary lymph 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)

PositiveAxillaryNodeHematoxylinAndEosinStainingAssessmentCount

Item

Number of positive axillary nodes by H&E (enter '0' if no positive nodes)

float

C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C23011 (NCI Thesaurus Property-2)
C0523207 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

PositiveAxillaryNodeImmunohistochemistryAssessmentCount

Item

Number of positive axillary nodes by IHC only (enter '0' if no positive nodes)

float

C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16722 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Section I - Unilateral Disease - Either Side, Continued

Item Group

Breast: Disease Description

FirstBiopsyPositiveDate

Item

Date of Initial Diagnosis of Primary Tumor (Date of first positive biopsy)

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)

PathologicTumorPrimarySizeMeasurement

Item

Pathologic Primary Tumor Size (cm Maximum diameter of the invasive component; if multiple lesions, use longest lesion)

float

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS 2011AA ObjectClass-2)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property-2)
C0456389 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

BreastTumorHistologicGrade

Item

Histologic Grade (For breast cancer, a combined histologic grade is used according to SBR/Elston classification)

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 (For breast cancer, a combined histologic grade is used according to SBR/Elston classification)

CL Item

Well Differentiated (Grade I (low))

CL Item

Moderately Differentiated (Grade II (intermediate))

CL Item

Poorly Differentiated (Grade III (high))

CL Item

Unknown (UNKNOWN)

BreastNeoplasmNuclearGradeCategory

Item

Nuclear Grade

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property-2)
C0441800 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)

CL.21

Code List

Nuclear Grade

CL Item

Low (Low)

CL124342 (NCI Metathesaurus)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

High (High)

C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ERLevelTumorStatus

Item

Receptor Status, ER (as defined by local laboratory; borderline results should be reported as positive)

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.22

Code List

Receptor Status, ER (as defined by local laboratory; borderline results should be reported as positive)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (NOT DONE)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (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.23

Code List

Receptor Status, PgR

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (NOT DONE)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

Item

Oncotype DX Recurrence Score (If ER+:)

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)

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Item

Her2/neu expression status by immunohistochemistry (DAKO HercepTest)

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass-2)
C0010802 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C61381 (NCI Thesaurus Property-3)
C0312586 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.24

Code List

Her2/neu expression status by immunohistochemistry (DAKO HercepTest)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

CL Item

Not Done: C49484 (not done)

C49484 (NCI Thesaurus)
C1272696 (UMLS 2011AA)

FISHAssessmentChromosome17ResultHER2NeuNumber

Item

FISH HER2/neu chromosome 17 Ratio

float

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property-2)
C0008659 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)

Laboratory Procedure Not Performed

Item

Mark an 'X' if not done

text

C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Section II Continued - Complete this section ONLY when reporting Bilateral disease

Item Group

Breast: Surgical Procedures

Section II Continued - Complete this section ONLY when reporting Bilateral disease.

Item Group

Breast: Disease Description

Footer Module

Item Group

Footer Module

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date

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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E5103 On-Study Form NCT00433511

Instructions: Complete this form and submit original to the ECOG Coordinating Center within one week of registrations. Keep a copy for your files.

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