ID

6989

Beschrijving

North Central Cancer Treatment Group - Central Her2 Testing Form - FISH 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-FEAD-5E3F-E044-0003BA3F9857

Link

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

Trefwoorden

Versies (2)
  1. 19-09-12 19-09-12 -
  2. 08-01-15 08-01-15 - Martin Dugas
Geüploaded op

8 januari 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Neoplasms, Breast NCT00490139 Pathology - North Central Cancer Treatment Group - Central Her2 Testing Form - FISH - 2639126v1.0

Engels

For Dr. Jenkins' Laboratory Use Only:

1 Formulieren  
  1. StudyEvent: North Central Cancer Treatment Group - Central Her2 Testing Form - FISH
    1. For Dr. Jenkins' Laboratory Use Only:
Header Module
Beschrijving

Header Module

NCCTG Protocol Number
Beschrijving

Protocol ID NCCTG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1518419
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25581
Central Pathology ID
Beschrijving

PathologyCoreFacilityLaboratoryIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass-2
C18189
UMLS 2011AA ObjectClass-2
C0030664
NCI Thesaurus ObjectClass-3
C15896
UMLS 2011AA ObjectClass-3
C1511521
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Number
Beschrijving

Institution Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution
Beschrijving

Institution Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Are data amended
Beschrijving

Data amended

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Header
Beschrijving

Header

FISH HER2/neu chromosome 17 Ratio
Beschrijving

FISHAssessmentChromosome17ResultHER2NeuNumber

Datatype

float

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13212
UMLS 2011AA Property-2
C0008659
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C17756
UMLS 2011AA ValueDomain-2
C0242957
Percentage greater than or equal to 3 Chromosome 17 signals
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureChromosome17SignalPolysomyResultPercentageValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C36331
UMLS 2011AA Property-2
C1514212
NCI Thesaurus Property-3
C13212
UMLS 2011AA Property-3
C0008659
NCI Thesaurus Property-4
C43382
UMLS 2011AA Property-4
C1710082
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NACA (No apparent Chromosome 17 anomaly)
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureChromosome17MolecularGeneticAbnormalityResultInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13212
UMLS 2011AA Property-2
C0008659
NCI Thesaurus Property-3
C36391
UMLS 2011AA Property-3
C1704257
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Her2 status / FISH via Vysis Probe
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureResultType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
Why no result
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureAbsentResultReason

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C48190
UMLS 2011AA Property
C0332197
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Specify
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureAbsentResultSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C48190
UMLS 2011AA Property
C0332197
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Chromosome 17 copy number
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureChromosome17SignalResultCount

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13212
UMLS 2011AA Property-2
C0008659
NCI Thesaurus Property-3
C43382
UMLS 2011AA Property-3
C1710082
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Other features
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureOtherResultType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specify
Beschrijving

FluorescenceinsituHybridizationDiagnosticProcedureOtherResultSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Footer Module
Beschrijving

Footer Module

Pathologist CTEP ID
Beschrijving

CancerTherapyEvaluationProgramPathologistIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17723
UMLS 2011AA ObjectClass
C0334866
NCI Thesaurus ObjectClass-2
C15794
UMLS 2011AA ObjectClass-2
C1516234
Date
Beschrijving

Assessment Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
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Similar models

For Dr. Jenkins' Laboratory Use Only:

1 Formulieren
  1. StudyEvent: North Central Cancer Treatment Group - Central Her2 Testing Form - FISH
    1. For Dr. Jenkins' Laboratory Use Only:
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header Module
Protocol ID NCCTG
Item
NCCTG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1518419 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25581 (NCI Thesaurus Property-2)
PathologyCoreFacilityLaboratoryIdentifierNumber
Item
Central Pathology ID
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Header
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)
FluorescenceinsituHybridizationDiagnosticProcedureChromosome17SignalPolysomyResultPercentageValue
Item
Percentage greater than or equal to 3 Chromosome 17 signals
float
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C36331 (NCI Thesaurus Property-2)
C1514212 (UMLS 2011AA Property-2)
C13212 (NCI Thesaurus Property-3)
C0008659 (UMLS 2011AA Property-3)
C43382 (NCI Thesaurus Property-4)
C1710082 (UMLS 2011AA Property-4)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
FluorescenceinsituHybridizationDiagnosticProcedureChromosome17MolecularGeneticAbnormalityResultInd-2
Item
NACA (No apparent Chromosome 17 anomaly)
boolean
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property-2)
C0008659 (UMLS 2011AA Property-2)
C36391 (NCI Thesaurus Property-3)
C1704257 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Her2 status / FISH via Vysis Probe
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
CL.3
Code List
Her2 status / FISH via Vysis Probe
CL Item
Amplified (Amplified)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Not Amplified (Not amplified)
CL Item
No Her2 Result / Not Done (No HER2 result / Not done)
Item
Why no result
text
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C48190 (NCI Thesaurus Property)
C0332197 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.4
Code List
Why no result
CL Item
Interductal Only (Interductal only)
CL Item
Hybridization Failure (hybridization failure)
CL Item
Insufficient Tissue (Insufficient tissue)
CL Item
No Cancer Tissue (No cancer tissue)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
FluorescenceinsituHybridizationDiagnosticProcedureAbsentResultSpecify
Item
Specify
text
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C48190 (NCI Thesaurus Property)
C0332197 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Chromosome 17 copy number
text
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property-2)
C0008659 (UMLS 2011AA Property-2)
C43382 (NCI Thesaurus Property-3)
C1710082 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.5
Code List
Chromosome 17 copy number
CL Item
Polysomy (Polysomy)
C36331 (NCI Thesaurus)
C1514212 (UMLS 2011AA)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Monosomy (Monosomy)
C3239 (NCI Thesaurus)
C0026499 (UMLS 2011AA)
Item
Other features
text
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
Other features
CL Item
Duplication Of Her2 (Duplication of HER2)
CL Item
Most Cells With No Centromere 17 (Most cells with no centromere 17)
CL Item
Negative Her2 (Negative HER2)
CL Item
Normal Her2 (Normal HER2)
CL Item
Not A Small Clone (Not a small clone)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Small Clone Of Amplification (Small clone of amplification)
FluorescenceinsituHybridizationDiagnosticProcedureOtherResultSpecify
Item
Specify
text
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
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-2)
C1516234 (UMLS 2011AA ObjectClass-2)
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)
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