ID

10619

Description

CALGB: HER-2/NEU Status Form NCT00053339 Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D12AD-990B-4739-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D12AD-990B-4739-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 5/22/15 5/22/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB: HER-2/NEU Status Form NCT00053339

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. Do not leave any entries blank. Enter -1 to indicate that an answer in unknown, unobtainable, not applicable, or not done. Retain a copy for your records and submit ORIGINAL to the CALGB Data Management Center.

1 forms  
CALGB Information
Description

CALGB Information

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

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient clinical trial data
Description

Patient clinical trial data

Patient's Name
Description

Patient'sName

Data type

text

Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

AffiliateName

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientID

Data type

text

Sample Data
Description

Sample Data

Could the tissue sample be evaluated?
Description

SpecimenCondition

Data type

text

If no, specify reason (sample could not be evaluated)
Description

Ifno,specifyreason(samplecouldnotbeevaluated)

Data type

text

Testing Data
Description

Testing Data

Tumor site tested
Description

Tumorsitetested

Data type

text

Staining antibody used for IHC
Description

StainingAntibody

Data type

text

Other, specify (staining antibody)
Description

StainingAntibody,Other

Data type

text

Serum ECD test
Description

SerumECDtest

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify (serum ECD test)
Description

Other,specify(serumECDtest)

Data type

text

Method of testing
Description

TumorMarkerTestMethod

Data type

text

Kit used for FISH
Description

FISHKitorTestType

Data type

text

Other, specify (FISH Kit)
Description

FISHKitorTestType,Other

Data type

double

Testing Results
Description

Testing Results

Her-2/neu Status
Description

HER2/neuFinalDiagnosis

Data type

text

IHC Lab value
Description

HerceptestScore

Data type

text

Completed by
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date completed
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Calgb: Her-2/neu Status Form
Description

Ccrr Module For Calgb: Her-2/neu Status Form

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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. Do not leave any entries blank. Enter -1 to indicate that an answer in unknown, unobtainable, not applicable, or not done. Retain a copy for your records and submit ORIGINAL to the CALGB Data Management Center.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB Information
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient clinical trial data
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
AffiliateName
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
Item Group
Sample Data
Item
Could the tissue sample be evaluated?
text
CL.2
Code List
Could the tissue sample be evaluated?
CL Item
Damaged Or Unusable (no)
CL Item
Useable (yes)
Ifno,specifyreason(samplecouldnotbeevaluated)
Item
If no, specify reason (sample could not be evaluated)
text
Item Group
Testing Data
Item
Tumor site tested
text
CL.3
Code List
Tumor site tested
CL Item
Primary (primary)
C25251 (NCI Thesaurus)
C0205225 (UMLS 2011AA)
CL Item
Metastatic (metastatic)
C14174 (NCI Thesaurus)
C0036525 (UMLS 2011AA)
Item
Staining antibody used for IHC
text
CL.4
Code List
Staining antibody used for IHC
CL Item
Cb-11/ventana Kit (CB11)
CL Item
Dako Herceptest [tm] (DAKO A0485 [Herceptest])
CL Item
Other, Specify (Other, specify)
StainingAntibody,Other
Item
Other, specify (staining antibody)
text
Item
Serum ECD test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Serum ECD test
CL Item
Other, Specify (Other, specify)
Other,specify(serumECDtest)
Item
Other, specify (serum ECD test)
text
Item
Method of testing
text
CL.6
Code List
Method of testing
CL Item
Immunohistochemistry (ihc) (Immunohistochemistry (IHC))
CL Item
Fluorescence In Situ Hybridization (fish) (Fluorescent in-situ hybridization (FISH))
Item
Kit used for FISH
text
CL.7
Code List
Kit used for FISH
CL Item
Vysis/path Vysion[tm] (Vysis)
CL Item
Ventana/oncorprobe[tm] (Ventana)
CL Item
Other, Specify (Other, specify)
FISHKitorTestType,Other
Item
Other, specify (FISH Kit)
double
Item Group
Testing Results
Item
Her-2/neu Status
text
CL.8
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
IHC Lab value
text
CL.9
Code List
IHC Lab value
CL Item
0 (0 or 0% cells staining)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1 or 1-10% cells staining)
CL Item
2+ (2 or 11-49% cells staining)
CL Item
3+ (3 or 50-100% cells staining)
PersonCompletingForm,FirstName
Item
Completed by
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date completed
date
Item Group
Ccrr Module For Calgb: Her-2/neu Status Form
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