ID

11292

Descrizione

Z1041: Surgery Report (SR) NCT00513292 Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=20FE940E-EC37-2E9D-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=20FE940E-EC37-2E9D-E044-0003BA3F9857

Keywords

versioni (3)
  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 27/06/15 27/06/15 -
Caricato su

27 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Z1041: Surgery Report (SR) NCT00513292

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Z1041: Surgery Report (SR)
    1. No Instruction available.
Header module
Descrizione

Header module

Visit
Descrizione

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Patient ID (Pt. ID issued during registration or previously issued patient ID)
Descrizione

Patient Study ID

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Initials (F M L)
Descrizione

Patient Initials

Tipo di dati

text

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

Institution Number

Tipo di dati

text

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

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Surgery assessment
Descrizione

Surgery assessment

Was primary breast surgery performed
Descrizione

SurgicalProcedureBreastNeoplasmPerformedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property-2
C2910
UMLS 2011AA Property-2
C0042875
Surgery Date (If yes,)
Descrizione

Surgery Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1628561
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus Property
C25275
Reason surgery not performed
Descrizione

ProtocolSurgeryNotPerformedReason

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Descrizione

ProtocolSurgeryNotPerformedSpecify

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Type of procedure performed
Descrizione

SurgicalProcedureBreastNeoplasmPerformedType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property-2
C2910
UMLS 2011AA Property-2
C0042875
Other, specify
Descrizione

PrimarySurgicalProcedurePerformedSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
Pathologic Response (NOTE: Refer to Protocol Section 7.6.2)
Descrizione

MalignantNeoplasmPathologicResponseStatus

Tipo di dati

text

Alias
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C50995
UMLS 2011AA Property-2
C1704632
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Gross residual tumor resected
Descrizione

GrossResidualMalignantNeoplasmSurgicalProcedurePerformedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus ObjectClass-3
C37895
UMLS 2011AA ObjectClass-3
C1609982
NCI Thesaurus ObjectClass-4
C43566
UMLS 2011AA ObjectClass-4
C0439806
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Tumor Pathology (if Resected)
Descrizione

Tumor Pathology (if Resected)

Longest diameter (Tumor size - cm)
Descrizione

Longest Diameter of Lesion

Tipo di dati

float

Unità di misura
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
UMLS CUI-1
C0221198
NCI Thesaurus Property
C25285
UMLS CUI-2
C1301886
NCI Thesaurus Property-2
C25558
UMLS CUI-3
C1522425
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ValueDomain-2
C25285
cm
Margin Status (mark one)
Descrizione

BreastCancerSurgeryMarginStatus

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C4872
UMLS 2011AA ObjectClass-2
C0678222
NCI Thesaurus Property
C25563
UMLS 2011AA Property
C0205284
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Histologic Grade
Descrizione

BreastTumorHistologicGrade

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain-2
C18000
UMLS 2011AA ValueDomain-2
C0919553
Completed by
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
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
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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: Z1041: Surgery Report (SR)
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header module
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Visit
CL Item
Surgery (Surgery)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials (F M L)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
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 Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Item Group
Surgery assessment
SurgicalProcedureBreastNeoplasmPerformedInd-2
Item
Was primary breast surgery performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2910 (NCI Thesaurus Property-2)
C0042875 (UMLS 2011AA Property-2)
Surgery Date
Item
Surgery Date (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item
Reason surgery not performed
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.3
Code List
Reason surgery not performed
CL Item
Disease Progression (Disease progression)
C17747 (NCI Thesaurus)
C0242656 (UMLS 2011AA)
CL Item
Patient Refusal (Patient refusal)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ProtocolSurgeryNotPerformedSpecify
Item
Other, specify
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Type of procedure performed
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2910 (NCI Thesaurus Property-2)
C0042875 (UMLS 2011AA Property-2)
CL.4
Code List
Type of procedure performed
CL Item
Partial Mastectomy - With Re-excision (Partial Mastectomy with re-excision)
CL Item
Partial Mastectomy Without Re-excision (Partial Mastectomy without re-excision)
CL Item
Modified Radical Mastectomy (Modified Radical Mastectomy)
C15278 (NCI Thesaurus)
C0024883 (UMLS 2011AA)
CL Item
Radical Mastectomy (Radical Mastectomy)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PrimarySurgicalProcedurePerformedSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
Item
Pathologic Response (NOTE: Refer to Protocol Section 7.6.2)
text
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C50995 (NCI Thesaurus Property-2)
C1704632 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.5
Code List
Pathologic Response (NOTE: Refer to Protocol Section 7.6.2)
CL Item
Pathologic Complete Response (Pathologic Complete Response)
CL Item
Not Pathologic Complete Response (Not Pathologic Complete Response)
GrossResidualMalignantNeoplasmSurgicalProcedurePerformedInd-2
Item
Gross residual tumor resected
boolean
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C37895 (NCI Thesaurus ObjectClass-3)
C1609982 (UMLS 2011AA ObjectClass-3)
C43566 (NCI Thesaurus ObjectClass-4)
C0439806 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Tumor Pathology (if Resected)
Longest Diameter of Lesion
Item
Longest diameter (Tumor size - cm)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS CUI-1)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS CUI-2)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS CUI-3)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
Item
Margin Status (mark one)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass-2)
C0678222 (UMLS 2011AA ObjectClass-2)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.7
Code List
Margin Status (mark one)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Close (Close)
Item
Histologic Grade
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.8
Code List
Histologic Grade
CL Item
Well Differentiated (Grade I (low))
CL Item
Moderately Differentiated (Grade II (intermediate))
CL Item
Poorly Differentiated (Grade III (high))
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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