CALGB: HER-2/NEU Status Form NCT00053339

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

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.

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)
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
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
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
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)
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
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
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
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
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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