ID

9383

Description

NSABP Protocol B-40 - On-Study Form A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B3E2A3A-F3C8-3045-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B3E2A3A-F3C8-3045-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 4/1/15 4/1/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00408408 On-Study - NSABP Protocol B-40 - On-Study Form - 2509534v1.0

English

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 forms  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Unnamed2
Description

Unnamed2

Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Person Completing Form, Last Name
Description

ResponsiblePersonLastName

Data type

text

Person Completing Form, First Name
Description

ResponsiblePersonFirstName

Data type

text

Person Completing Form, Phone
Description

ResponsiblePersonPhoneNumber

Data type

text

Date Form Completed
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Are data amended
Description

DataAmendedInd-3

Data type

boolean

Tumor Laterality
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
Unnamed3
Description

Unnamed3

Histologic Type (from diagnostic core needle biopsy - Mark predominant tumor type if more than one applies.)
Description

BreastTumorHistologicCategory

Data type

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
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Other specify
Description

Histologic Type, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Receptor Status, ER (from diagnostic core needle biopsy)
Description

ERLevelTumorStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Receptor Status, PgR
Description

PgRStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
Histologic Grade (from diagnostic core needle biopsy Use combined histologic grade SBR/Elston classification.)
Description

BreastTumorHistologicGrade

Data type

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
Was HER-2/neu status determined
Description

EpidermalGrowthFactorReceptorAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus ObjectClass
C17068
UMLS 2011AA ObjectClass
C0034802
HER-2/neu status (if yes from core needle biopsy - )
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
Unnamed5
Description

Unnamed5

Does the patient have any first degree relatives who died from heart disease before the age of 55 ("First degree relatives" include parents, children, brothers and sisters.)
Description

FirstDegreeRelativeCardiovascularDisorderDeathInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus Property-2
C2931
UMLS 2011AA Property-2
C0007222
NCI Thesaurus ObjectClass
C21481
UMLS 2011AA ObjectClass
C1517194
Unnamed6
Description

Unnamed6

Did the patient take medications for any of the following medical conditions in the 12 months prior to study entry
Description

MedicationPriorMedicalConditionReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus Property-3
C25261
UMLS 2011AA Property-3
C0205476
NCI Thesaurus Property-4
C25457
UMLS 2011AA Property-4
C0348080
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Medical Condition
Description

PatientMedicalConditionCurrentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property-2
C25457
UMLS 2011AA Property-2
C0348080
Medications (in the 12 months prior to study entry)
Description

MedicationPriorReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
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Similar models

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Unnamed2
CombinedInstitutionName
Item
Institution/Affiliate
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
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)
DataAmendedInd-3
Item
Are data amended
boolean
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
CL.2
Code List
Tumor Laterality
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
Item Group
Unnamed3
Item
Histologic Type (from diagnostic core needle biopsy - Mark predominant tumor type if more than one applies.)
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)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.3
Code List
Histologic Type (from diagnostic core needle biopsy - Mark predominant tumor type if more than one applies.)
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular (pure > or =90%))
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
CL Item
Other Specify (Other)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
Item
Receptor Status, ER (from diagnostic core needle biopsy)
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL.4
Code List
Receptor Status, ER (from diagnostic core needle biopsy)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Receptor Status, PgR
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
CL.5
Code List
Receptor Status, PgR
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Histologic Grade (from diagnostic core needle biopsy Use combined histologic grade SBR/Elston classification.)
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.6
Code List
Histologic Grade (from diagnostic core needle biopsy Use combined histologic grade SBR/Elston classification.)
CL Item
Well Differentiated (Grade I (low))
CL Item
Moderately Differentiated (Grade II (intermediate))
CL Item
Poorly Differentiated (Grade III (high))
EpidermalGrowthFactorReceptorAssessmentInd-2
Item
Was HER-2/neu status determined
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C17068 (NCI Thesaurus ObjectClass)
C0034802 (UMLS 2011AA ObjectClass)
Item
HER-2/neu status (if yes from core needle biopsy - )
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 (if yes from core needle biopsy - )
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item Group
Unnamed5
FirstDegreeRelativeCardiovascularDisorderDeathInd-2
Item
Does the patient have any first degree relatives who died from heart disease before the age of 55 ("First degree relatives" include parents, children, brothers and sisters.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C2931 (NCI Thesaurus Property-2)
C0007222 (UMLS 2011AA Property-2)
C21481 (NCI Thesaurus ObjectClass)
C1517194 (UMLS 2011AA ObjectClass)
Item Group
Unnamed6
MedicationPriorMedicalConditionReceivedInd-2
Item
Did the patient take medications for any of the following medical conditions in the 12 months prior to study entry
boolean
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C25261 (NCI Thesaurus Property-3)
C0205476 (UMLS 2011AA Property-3)
C25457 (NCI Thesaurus Property-4)
C0348080 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Medical Condition
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
CL.11
Code List
Medical Condition
CL Item
Hypertension (hypertension)
C3117 (NCI Thesaurus)
C0020538 (UMLS 2011AA)
CL Item
Angina (Angina)
C51221 (NCI Thesaurus)
C0002962 (UMLS 2011AA)
CL Item
Myocardial Infarction (Myocardial Infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Congestive Heart Failure (Congestive Heart Failure)
C3080 (NCI Thesaurus)
C0018802 (UMLS 2011AA)
CL Item
Atrial Fibrillation: C50466 (Atrial Arrhythmia)
C50466 (NCI Thesaurus)
C0004238 (UMLS 2011AA)
CL Item
Ventricular Arrhythmia (Ventricular Arrhythmia)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
CL Item
Diabetes (diabetes)
CL Item
Elevated Fasting Lipid Profile (Elevated Fasting Lipid Profile)
MedicationPriorReceivedInd-2
Item
Medications (in the 12 months prior to study entry)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
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