ID

2783

Beskrivning

North Central Cancer Treatment Group - Central Her2 Testing Form - IHC ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=30AFEA0B-FE87-5E3F-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=30AFEA0B-FE87-5E3F-E044-0003BA3F9857

Nyckelord

2012-09-19 2012-09-19 -
2015-01-08 2015-01-08 - Martin Dugas

Uppladdad den

19 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Neoplasms, Breast NCT00490139 Pathology - North Central Cancer Treatment Group - Central Her2 Testing Form - IHC - 2639107v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: North Central Cancer Treatment Group - Central Her2 Testing Form - IHC
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header Module

Item Group

Header Module

ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber

Item

NCCTG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Central Pathology ID

text

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

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)

InstitutionIdentifierNumber

Item

Institution Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

InstitutionName

Item

Institution

text

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

Unnamed1

Item Group

Unnamed1

DataAmendedInd-3

Item

Are data amended

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

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)

For Dr. Ann McCullough's Laboratory Use Only

Item Group

For Dr. Ann Mccullough's Laboratory Use Only

PathologyTissueSpecimenCompleteMembraneStainMalignantCellPercentageValue

Item

Percentage of invasive tumor cells with complete membrane staining

double

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C12749 (NCI Thesaurus Property)
C0025255 (UMLS 2011AA Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

TissueSpecimenImmunohistochemistryStainHomogeneityPatternIndicator

Item

Uniformity of staining

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)
C61365 (NCI Thesaurus Property)
C1881065 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.2

Code List

Uniformity of staining

CL Item

Present (Present)

C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)

CL Item

Absent (Absent)

C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)

TissueSpecimenImmunohistochemistryStainHomogeneityCircumferencePatternIndicator

Item

Homogeneous dark circumferential pattern

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)
C61365 (NCI Thesaurus Property)
C1881065 (UMLS 2011AA Property)
C64265 (NCI Thesaurus Property)
C0332520 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.3

Code List

Homogeneous dark circumferential pattern

CL Item

Present (Present)

C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)

CL Item

Absent (Absent)

C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)

LaboratoryProcedureHER2/neuImmunohistochemistryResultStatus

Item

IHC Result

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.4

Code List

IHC Result

CL Item

No Staining Or Membranous Staining <=10% Cells (No staining or membranous staining <=10% cells (Negative - 0))

CL Item

Faint Membrane Staining, Partial >10% Cells (Faint membrane staining, partial >10% cells (Negative - 1+))

CL Item

Weak To Moderate Staining, Complete >10% Cells (Weak to moderate staining, complete >10% cells (Equivocal - 2+))

CL Item

Strong Staining, Complete >10% <=30% Cells (Strong staining, complete >10% <=30% cells (Equivocal - 3+))

CL Item

Strong Staining, Complete >30% Cells (Strong staining, complete >30% cells (Positive - 3+))

CL Item

Insufficient Tissue/hybridization Failure (Insufficient tissue/hybridization failure)

BreastTumorHistologicCategory

Item

Histologic Type

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)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.5

Code List

Histologic Type

CL Item

Ductal Nos (Ductal NOS)

CL Item

Lobular (Lobular (pure > or =90%))

C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)

CL Item

Mixed Ductal And Lobular (Mixed ductal and lobular)

CL Item

Tubular (Tubular (pure > or =90%))

C14169 (NCI Thesaurus)
C0332208 (UMLS 2011AA)

CL Item

Apocrine (Apocrine)

CL Item

Tubulolobular (Tubulolobular (pure > or =90%))

CL Item

Micropapillary (Micropapillary)

CL Item

Cribriform (Cribriform)

C25731 (NCI Thesaurus)
C1621425 (UMLS 2011AA)
C25731 (NCI Thesaurus)
C1621425 (UMLS 2011AA)

CL Item

Mucinous Adenocarcinoma (Mucinous)

C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)
C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)

CL Item

Invasive Nos (Invasive NOS)

CL Item

Medullary Carcinoma (Medullary)

C8998 (NCI Thesaurus)

CL Item

Other Specify (Other)

TumorHistologicCategorySpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

CISDiagnosisInd-3

Item

Is CIS present?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2917 (NCI Thesaurus ObjectClass)
C0007099 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.6

Code List

Is CIS present?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Stage0BreastCancerHistologicCategory

Item

Histologic type

text

C3641 (NCI Thesaurus ObjectClass)
C0154084 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.7

Code List

Histologic type

CL Item

Ductal Breast Carcinoma In Situ (DCIS)

C2924 (NCI Thesaurus)
C0007124 (UMLS 2011AA)

CL Item

Lobular Carcinoma In Situ (LCIS)

CL Item

Mixed Ductal And Lobular (Mixed DCIS & LCIS)

Paget'sDiseasePresentInd-3

Item

Is Paget's disease of the nipple present?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3292 (NCI Thesaurus ObjectClass)
C0029401 (UMLS 2011AA ObjectClass)

CL.8

Code List

Is Paget's disease of the nipple present?

CL Item

No (NO)

CL Item

Yes (YES)

BreastTumorHistologicGrade

Item

Histologic Grade

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.9

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)

PrimaryTumorSizeMeasurement

Item

Clinical Size of Tumor

double

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

TumorVascularInvasionInd-3

Item

Is there vascular invasion

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13311 (NCI Thesaurus Property)
C1801960 (UMLS 2011AA Property)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)

CL.10

Code List

Is there vascular invasion

CL Item

Yes (YES)

CL Item

No (NO)

LaboratoryProcedureMicroarrayResultInd-3

Item

Suitable for TMA

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C44282 (NCI Thesaurus Property)
C1709016 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.11

Code List

Suitable for TMA

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureEstrogenReceptorPositiveCellResultPercentageValue

Item

ER % cells stained positive

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C17069 (NCI Thesaurus Property)
C0034804 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureProgesteroneReceptorPositiveCellResultPercentageValue

Item

PgR % cells stained positive

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C17075 (NCI Thesaurus Property)
C0034833 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Footer Module

Item Group

Footer Module

CancerTherapyEvaluationProgramPathologistIdentifierNumber

Item

Pathologist CTEP ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17723 (NCI Thesaurus ObjectClass)
C0334866 (UMLS 2011AA ObjectClass)
C15794 (NCI Thesaurus ObjectClass)
C1516234 (UMLS 2011AA ObjectClass)

AssessmentPerformedDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

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Nyckelord

Versioner (2)

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DOI

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Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

Neoplasms, Breast NCT00490139 Pathology - North Central Cancer Treatment Group - Central Her2 Testing Form - IHC - 2639107v1.0

No Instruction available.

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