ID

2926

Description

Phase II Breast Cancer - Adjuvant On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24E7C2C2-27C7-70B6-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24E7C2C2-27C7-70B6-E044-0003BA3F9857

Mots-clés

Téléchargé le

19 septembre 2012

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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On-Study - Phase II Breast Cancer - Adjuvant On-Study Form - 2556117v1.0

model
Détails

No Instruction available.

1 Formulaires

StudyEvent: Phase II Breast Cancer - Adjuvant On-Study Form
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

CRF Header

Item Group

Crf Header

ProtocolCoordinatingIdentifierNumber

Item

Coordinating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CoordinatingGroupIdentifierCode

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus ObjectClass)
C0700114 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolTitleName

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)

PatientCoordinatingIdentifierNumber

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteringGroupIdentifierCode

Item

Registering Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25645 (NCI Thesaurus ObjectClass)

RegisteringInstitutionIdentifierCode

Item

Registering Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25645 (NCI Thesaurus ObjectClass)

PatientInitialsName

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

Breast: Form Administration

Item Group

Breast: Form Administration

ResponsiblePersonName

Item

Person Completing Form

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended? (If data are amended, please circle in red when using paper form)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended? (If data are amended, please circle in red when using paper form)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Breast: Patient Characteristics

Item Group

Breast: Patient Characteristics

PatientAgeValue

Item

Patient Age

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)

PatientMenopauseStatus

Item

Menopausal status

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.2

Code List

Menopausal status

CL Item

Premenopausal (Premenopausal)

C15491 (NCI Thesaurus)
C0279752 (UMLS 2011AA)

CL Item

Perimenopausal (Perimenopausal)

C15692 (NCI Thesaurus)
C0677925 (UMLS 2011AA)

CL Item

Postmenopausal (Postmenopausal (>12 mo since LMP with no prior ovariectomy))

C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)

CL Item

Postmenopausal (Postmenopausal (prior bilateral ovariectomy))

C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)

HormoneTherapyAdministeredInd-3

Item

Hormone Therapy/Replacement

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.3

Code List

Hormone Therapy/Replacement

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HormoneTherapyCurrentAdministeredType

Item

Hormone Therapy Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.4

Code List

Hormone Therapy Type

CL Item

Lhrh Agonist (LHRH agonist)

CL Item

Estrogen Replacement (Estrogen Replacement)

Breast: Surgical Procedures

Item Group

Breast: Surgical Procedures

FirstBiopsyPositiveDate

Item

First Positive Biopsy Date (mm dd yyyy)

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

BreastPrimarySurgicalProcedurePerformedType

Item

Most Extensive Primary Surgery (check one)

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.5

Code List

Most Extensive Primary Surgery (check one)

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 (if required, use last re-excision date)

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

SentinelNodeBiopsyInd-3

Item

Was sentinel node sampling performed

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

CL.6

Code List

Was sentinel node sampling performed

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SentinelNodeBiopsyDate

Item

Sentinel Node Biopsy Date (mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

SentinelNodeExaminedCount

Item

Number of Sentinel Nodes Examined

double

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

double

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)

SentinelNodeBiopsyResultStatus

Item

Sentinel Node Biopsy Results (per protocol)

text

C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.7

Code List

Sentinel Node Biopsy Results (per protocol)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

AxillaryNodeDissectionInd-3

Item

Was axillary dissection performed?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)

CL.8

Code List

Was axillary dissection performed?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AxillarySurgeryDissectionDate

Item

Date of Axillary Dissection (mm dd yyyy)

date

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

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined (If sentinel node biopsy and axillary node dissection were performed, enter the sum of nodes examined.)

double

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 (per institutional standard)

double

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Breast: Disease Description

Item Group

Breast: Disease Description

PrimaryTumorLateralityType

Item

Tumor Laterality (check one)

text

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

CL.9

Code List

Tumor Laterality (check one)

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)

ERLevelTumorStatus

Item

Receptor Status, ER (If measured in fmols/mg cytosol protein >=10 is positive. If other measures are used apply institutional standards; 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)
C0449438 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.10

Code List

Receptor Status, ER (If measured in fmols/mg cytosol protein >=10 is positive. If other measures are used apply institutional standards; borderline results should be reported as positive.)

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.11

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)

HER2/neuStatusType

Item

Receptor Status, Her2-neu

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.12

Code List

Receptor Status, Her2-neu

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

TumorMarkerTestType

Item

Marker Test Method

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)

CL.13

Code List

Marker Test Method

CL Item

Immunohistochemistry (ihc) (Immunohistochemistry (IHC))

CL Item

Fluorescence In Situ Hybridization (fish) (Fluorescence in situ hybridization (FISH))

CL Item

Elisa (ELISA)

C16553 (NCI Thesaurus)
C0014441 (UMLS 2011AA)

CL Item

Other, Specify (Other)

TumorMarkerTestSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)

PathologyTissueSpecimenAntibodyStainingMethodType

Item

Staining Antibody

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property)
C0487602 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.14

Code List

Staining Antibody

CL Item

Dako Herceptest [tm] (DAKO Herceptest [TM])

CL Item

Cb-11/ventana Kit (CB-11/Ventana Kit)

CL Item

Cb-11 Other (CB-11 other)

CL Item

Tab-250 (TAB-250)

CL Item

Other Specify (Other)

PathologyTissueSpecimenAntibodyStainingMethodText

Item

Other specify

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property)
C0487602 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

BreastPathologySpecimenMalignantNucleusStainIntensityType

Item

Intensity of Stained Malignant Nuclei Description (OR)

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C13197 (NCI Thesaurus Property)
C0007610 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.15

Code List

Intensity of Stained Malignant Nuclei Description (OR)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Scant (Scant)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

Intense (Intense)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BreastPathologySpecimenMalignantNucleusStainIntensityScore

Item

Intensity of Stained Malignant Nuclei Scaled (__ of __ Note: Scale for intensity will be protocol specific.)

double

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C13197 (NCI Thesaurus Property)
C0007610 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Item

Herceptest Score

text

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

CL.16

Code List

Herceptest Score

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

BreastCytogeneticsHER2/neuMonoclonalAntibodyTestScore

Item

Ventana Scoring System (Score)

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass)
C0010802 (UMLS 2011AA ObjectClass)
C20401 (NCI Thesaurus Property)
C0003250 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.17

Code List

Ventana Scoring System (Score)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

FISHAssessmentTestType

Item

Kit or Test Type (If FISH,)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)

CL.18

Code List

Kit or Test Type (If FISH,)

CL Item

Vysis/path Vysion[tm] (Vysis/PathVysion)

CL Item

Ventana/oncorprobe[tm] (Ventana/Oncorprobe)

CL Item

Other Specify (Other)

FISHAssessmentTestSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)

FISHCytologyResultType

Item

FISH Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.19

Code List

FISH Result

CL Item

Amplified (Amplified)

CL Item

Not Amplified (Not amplified)

Unnamed1

Item Group

Unnamed1

PathologicTumorPrimarySizeMeasurement

Item

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

double

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

BreastTumorPathologicTStage

Item

T Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.20

Code List

T Stage, Pathologic

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (Tis)

CL Item

Microinvasion 0.1 Cm Or Less In Greatest Dimension (T1mic)

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

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

Primary Tumor Cannot Be Assessed (TX)

BreastTumorPathologicNStage

Item

N Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.21

Code List

N Stage, Pathologic

CL Item

No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)

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

Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)

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

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

M Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.22

Code List

M Stage, Pathologic

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)

BreastTumorStageGroupingStage

Item

Stage Grouping

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C38027 (NCI Thesaurus Property)
C1519504 (UMLS 2011AA Property)

CL.23

Code List

Stage Grouping

CL Item

Tis, N0, M0 (0)

CL Item

T1*, N0, M0 (I)

CL Item

T0, N1, M0 Or T1*, N1, M0 Or T2, N0, M0 (IIA)

CL Item

T2, N1, M0 Or T3, N0, M0 (IIB)

CL Item

T0, N2, M0 Or T1*, N2, M0 Or T2, N2, M0 Or T3, N1, M0 Or T3, N2, M0 (IIIA)

CL Item

T4, N0, M0 Or T4, N1, M0 Or T4, N2, M0 (IIIB)

CL Item

Any T, N3, M0 (IIIC)

CL Item

Any T, Any N, M1 (IV)

BreastTumorHistologicGrade

Item

Histologic Grade (For breast cancer, the Nottingham combined histologic grade is recommended)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.24

Code List

Histologic Grade (For breast cancer, the Nottingham combined histologic grade is recommended)

CL Item

Gx Grade Cannot Be Assessed (GX)

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)

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Mots-clés

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On-Study - Phase II Breast Cancer - Adjuvant On-Study Form - 2556117v1.0

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