ID

720

Description

CALGB: HER-2/neu TESTING FORM Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0DF2A238-0D66-4C86-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0DF2A238-0D66-4C86-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/3/15 7/3/15 -
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00024102 On-Study - CALGB: HER-2/neu TESTING FORM - 2453404v1.0

English

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms  
Unnamed1
Description

Unnamed1

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Amended data?
Description

Amendeddata?

Data type

text

Unnamed2
Description

Unnamed2

Patient Initials (Last, First Middle)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Participating Group
Description

ParticipatingGroupName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital No.
Description

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Participating Group Study No.
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Unnamed3
Description

Unnamed3

Immunohistochemistry Kit or Test Type (Mark all that apply with an X)
Description

StainingAntibody

Data type

text

Scoring System (Score) (Mark one with an X)
Description

HerceptestScore

Data type

text

Scoring System (Score) (Mark one with an X)
Description

HerceptestScore

Data type

text

Other, specify
Description

StainingAntibody,Other

Data type

text

Results
Description

LaboratoryProcedureHER2/neuImmunohistochemistryResultText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16722
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17756
UMLS 2011AA Property
C0242957
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C20200
UMLS 2011AA ValueDomain
C1274040
FISH Assessment Test Type (Mark all that apply with an X)
Description

FISHAssessmentTestType

Data type

text

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

FISHAssessmentChromosome17ResultHER2NeuNumber

Data type

double

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C13212
UMLS 2011AA Property
C0008659
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain
C17756
UMLS 2011AA ValueDomain
C0242957
Ventana Scoring System (Score)
Description

VentanaScore

Data type

text

Ventana Scoring System (Score)
Description

VentanaScore

Data type

text

Other, specify
Description

FISHAssessmentTestSpecify

Data type

text

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

FISHAssessmentTestResultText

Data type

text

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

Testing Results

HER-2/neu status (Mark one with an Xby institutional standards)
Description

HER2/neuStatusType

Data type

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
Ccrr Module For Calgb: 49907 Capecitabine Drug Supply Record Form
Description

Ccrr Module For Calgb: 49907 Capecitabine Drug Supply Record Form

Completed by
Description

ResponsiblePersonSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
Date Form Completed
Description

FormCompleteDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Item
Amended data?
text
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First Middle)
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)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Unnamed3
Item
Immunohistochemistry Kit or Test Type (Mark all that apply with an X)
text
CL.2
Code List
Immunohistochemistry Kit or Test Type (Mark all that apply with an X)
CL Item
Dako Herceptest [tm] (DAKO Herceptest [TM])
CL Item
Cb-11/ventana Kit (CB-11/Ventana Kit)
CL Item
Cb-11 Other (CB-11 other)
CL Item
Other, Specify (Other, specify)
CL Item
Ihc Not Done (IHC not done)
Item
Scoring System (Score) (Mark one with an X)
text
CL.5
Code List
Scoring System (Score) (Mark one with an X)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
Item
Scoring System (Score) (Mark one with an X)
text
CL.5
Code List
Scoring System (Score) (Mark one with an X)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
StainingAntibody,Other
Item
Other, specify
text
LaboratoryProcedureHER2/neuImmunohistochemistryResultText
Item
Results
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)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain)
C1274040 (UMLS 2011AA ValueDomain)
Item
FISH Assessment Test Type (Mark all that apply with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
CL.6
Code List
FISH Assessment Test Type (Mark all that apply with an X)
CL Item
Vysis/path Vysion[tm] (Vysis/PathVysion)
CL Item
Ventana Inform (Ventana INFORM)
CL Item
Other Specify (Other, specify)
CL Item
Fish Not Done (FISH not done)
FISHAssessmentChromosome17ResultHER2NeuNumber
Item
FISH HER2/neu chromosome 17 Ratio
double
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain)
C0242957 (UMLS 2011AA ValueDomain)
Item
Ventana Scoring System (Score)
text
CL.7
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
Ventana Scoring System (Score)
text
CL.7
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+)
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)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
FISHAssessmentTestResultText
Item
Results
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain)
C1274040 (UMLS 2011AA ValueDomain)
Item Group
Testing Results
Item
HER-2/neu status (Mark one with an Xby institutional standards)
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)
CL.8
Code List
HER-2/neu status (Mark one with an Xby institutional standards)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item Group
Ccrr Module For Calgb: 49907 Capecitabine Drug Supply Record Form
ResponsiblePersonSignatureText
Item
Completed by
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25678 (NCI Thesaurus Property)
C1519316 (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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