Breast Cancer NCT00513292 Treatment - Z1041: Surgery Report (SR) - 2533056v1.0

Z1041: Surgery Report (SR) 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

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  1. StudyEvent: Z1041: Surgery Report (SR)
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Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed 1
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)
C0545082 (UMLS 2011AA ObjectClass)
Code List
Visit
CL Item
Surgery (Surgery)
PatientCoordinatingIdentifierNumber
Item
Patient ID (Pt. ID issued during registration or previously issued patient 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)
PatientInitialsName
Item
Patient Initials (F M L)
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 No.
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 Name
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)
Item Group
Unnamed 2
Item
Was primary breast surgery performed
text
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)
C0042875 (UMLS 2011AA Property)
Code List
Was primary breast surgery performed
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
SurgeryDate
Item
Surgery Date (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Reason surgery not performed
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
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)
C0543467 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
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)
C0042875 (UMLS 2011AA Property)
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)
C0543467 (UMLS 2011AA ObjectClass)
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)
C1704632 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
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)
Item
Gross residual tumor resected
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C37895 (NCI Thesaurus ObjectClass)
C1609982 (UMLS 2011AA ObjectClass)
C43566 (NCI Thesaurus ObjectClass)
C0439806 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Gross residual tumor resected
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Tumor Pathology (if Resected)
LesionLongestDiameterMeasurement
Item
Longest diameter (Tumor size - cm)
double
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain)
C1301886 (UMLS 2011AA ValueDomain)
Item
Margin Status (mark one)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
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)
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)
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))
ResponsiblePersonName
Item
Completed by
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)
FormCompleteDate
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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