ID

11088

Descrizione

CALGB HER2/neu Testing Form NCT00770809 Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3CB1A910-D444-4DE4-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3CB1A910-D444-4DE4-E044-0003BA3F9857

Keywords

  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 18/06/15 18/06/15 -
Caricato su

18 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy

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CALGB HER2/neu Testing Form NCT00770809

INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

Header
Descrizione

Header

CALGB Form
Descrizione

Form ID CALGB

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Descrizione

Protocol ID CALGB

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Descrizione

Trial subject ID CALGB

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Amended Data
Descrizione

Data amended

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Descrizione

Patient demographics

Patient Initials (Last, First Middle)
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Descrizione

Medical Record Number

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Descrizione

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Descrizione

Participating Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Descrizione

Study Number Participating Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Descrizione

Trial subject ID Participating Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Testing Data
Descrizione

Testing Data

Immunohistochemistry Kit or Test Type
Descrizione

PathologyTissueSpecimenAntibodyStainingMethodType

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus ObjectClass-3
C18189
UMLS 2011AA ObjectClass-3
C0030664
NCI Thesaurus Property
C16295
UMLS 2011AA Property
C0003241
NCI Thesaurus Property-2
C23010
UMLS 2011AA Property-2
C0487602
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other specify
Descrizione

PathologyTissueSpecimenAntibodyStainingMethodText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus ObjectClass-3
C18189
UMLS 2011AA ObjectClass-3
C0030664
NCI Thesaurus Property
C16295
UMLS 2011AA Property
C0003241
NCI Thesaurus Property-2
C23010
UMLS 2011AA Property-2
C0487602
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Herceptest Score
Descrizione

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Tipo di dati

text

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

BreastCytogeneticsHER2/neuMonoclonalAntibodyTestScore

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C16487
UMLS 2011AA ObjectClass-2
C0010802
NCI Thesaurus Property
C20401
UMLS 2011AA Property
C0003250
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-3
C0242957
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Scoring system
Descrizione

LaboratoryProcedureHER2/neuImmunohistochemistryResultMonoclonalAntibodyCB11Score

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16722
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus ValueDomain
C20401
UMLS 2011AA ValueDomain
C0003250
NCI Thesaurus ValueDomain-2
C25338
UMLS 2011AA ValueDomain-2
C0449820
Results
Descrizione

LaboratoryProcedureHER2/neuImmunohistochemistryResultText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16722
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C20200
UMLS 2011AA ValueDomain-2
C1274040
FISH Kit or Test Type
Descrizione

FISHAssessmentTestType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
FISH HER2/neu chromosome 17 Ratio
Descrizione

FISHAssessmentChromosome17ResultHER2NeuNumber

Tipo di dati

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
Other, specify
Descrizione

FISHAssessmentTestSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
Results
Descrizione

FISHAssessmentTestResultText

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C20200
UMLS 2011AA ValueDomain-2
C1274040
Testing Results
Descrizione

Testing Results

HER-2/neu status
Descrizione

HER2/neuStatusType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17756
UMLS 2011AA ObjectClass
C0242957
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Footer Module
Descrizione

Footer Module

Completed by (Last name, First name)
Descrizione

Person Completing Form

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Descrizione

Date Form Completed

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Comments
Descrizione

Research Comments

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393

Similar models

INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Data amended
Item
Amended Data
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
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)
Item Group
Testing Data
Item
Immunohistochemistry Kit or Test Type
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C18189 (NCI Thesaurus ObjectClass-3)
C0030664 (UMLS 2011AA ObjectClass-3)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property-2)
C0487602 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Immunohistochemistry Kit or Test Type
CL Item
Cb-11 Other (CB-11 other)
CL Item
Cb-11/ventana Kit (CB-11/Ventana Kit)
CL Item
Dako Herceptest [tm] (DAKO Herceptest [TM])
CL Item
Ihc Not Done (IHC not done)
CL Item
Other Specify (Other)
PathologyTissueSpecimenAntibodyStainingMethodText
Item
Other specify
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C18189 (NCI Thesaurus ObjectClass-3)
C0030664 (UMLS 2011AA ObjectClass-3)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property-2)
C0487602 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Herceptest Score
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)
Code List
Herceptest Score
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
Item
Ventana Scoring System (Score)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass-2)
C0010802 (UMLS 2011AA ObjectClass-2)
C20401 (NCI Thesaurus Property)
C0003250 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
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+)
Item
Scoring system
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-2)
C20401 (NCI Thesaurus ValueDomain)
C0003250 (UMLS 2011AA ValueDomain)
C25338 (NCI Thesaurus ValueDomain-2)
C0449820 (UMLS 2011AA ValueDomain-2)
Code List
Scoring system
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
+1 (+1)
CL225712 (NCI Metathesaurus)
CL Item
2+ (2+)
CL Item
3+ (3+)
LaboratoryProcedureHER2/neuImmunohistochemistryResultText
Item
Results
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
Item
FISH Kit or Test Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
Code List
FISH Kit or Test Type
CL Item
Fish Not Done (FISH not done)
CL Item
Other Specify (Other, specify)
CL Item
Ventana Inform (Ventana INFORM)
CL Item
Vysis/path Vysion[tm] (Vysis/PathVysion)
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)
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-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
FISHAssessmentTestResultText
Item
Results
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
Item Group
Testing Results
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)
Code List
HER-2/neu status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item Group
Footer Module
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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