ID

10117

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 NCT00408408 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

April 1, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer On-Study NCT00408408 NSABP B-40

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

Alias
UMLS CUI-1
C1320722
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
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

Alias
UMLS CUI-1
C0680532
Patient characteristics
Description

Patient characteristics

Alias
UMLS CUI-1
C0815172
Tumor Laterality
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C25251
NCI Thesaurus Property
C25185
UMLS CUI-1
C2985714
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
NCI Thesaurus ObjectClass-2
C12971
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ValueDomain-2
C25526
UMLS CUI-1
C0449574
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
NCI Thesaurus ObjectClass
C17069
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25554
UMLS CUI-1
C1516974
Receptor Status, PgR
Description

PgRStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C17075
NCI Metathesaurus Property
C0678257
UMLS CUI-1
C0034833
Histologic Grade (from diagnostic core needle biopsy Use combined histologic grade SBR/Elston classification.)
Description

BreastTumorHistologicGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C12971
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25526
NCI Thesaurus ValueDomain-2
C18000
UMLS CUI-1
C0919553
HER-2/neu status (if yes from core needle biopsy - )
Description

HER2/neuStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C17756
NCI Thesaurus Property
C25365
UMLS CUI-1
C0069515
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
NCI Thesaurus Property
C28554
NCI Thesaurus Property-2
C2931
NCI Thesaurus ObjectClass
C21481
UMLS CUI-1
C2825161
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
NCI Thesaurus Property
C25629
NCI Thesaurus Property-2
C25639
NCI Thesaurus Property-3
C25261
NCI Thesaurus Property-4
C25457
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0013227
Medical Condition
Description

PatientMedicalConditionCurrentType

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25457
UMLS CUI-1
C0012634
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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
C1320722 (UMLS CUI-1)
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)
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)
Data amended
Item
Are data amended
boolean
C0680532 (UMLS CUI-1)
Item Group
Patient characteristics
C0815172 (UMLS CUI-1)
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C25185 (NCI Thesaurus Property)
C2985714 (UMLS CUI-1)
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
Histologic Type (from diagnostic core needle biopsy - Mark predominant tumor type if more than one applies.)
text
C3262 (NCI Thesaurus ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0449574 (UMLS CUI-1)
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 CUI-1)
CL Item
Other Specify (Other)
C1299220 (UMLS CUI-1)
CL Item
Lobular (90% or more) (Lobular)
C0205417 (UMLS CUI-1)
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)
C17069 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C25554 (NCI Thesaurus Property)
C1516974 (UMLS CUI-1)
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)
C17075 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C0034833 (UMLS CUI-1)
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)
C12971 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25526 (NCI Thesaurus ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS CUI-1)
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))
C0205615 (UMLS CUI-1)
CL Item
Moderately Differentiated (Grade II (intermediate))
C0205616 (UMLS CUI-1)
CL Item
Poorly Differentiated (Grade III (high))
C0205617 (UMLS CUI-1)
Item
HER-2/neu status (if yes from core needle biopsy - )
text
C25284 (NCI Thesaurus ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0069515 (UMLS CUI-1)
CL.8
Code List
HER-2/neu status (if yes from core needle biopsy - )
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS CUI-1)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS CUI-1)
CL Item
unknown (Unknown)
C0439673 (UMLS CUI-1)
Family history cardiac death
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)
C28554 (NCI Thesaurus Property)
C2931 (NCI Thesaurus Property-2)
C21481 (NCI Thesaurus ObjectClass)
C2825161 (UMLS CUI-1)
Prior medication
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)
C25629 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C25261 (NCI Thesaurus Property-3)
C25457 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI-1)
Item
Medical Condition
integer
C25284 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25457 (NCI Thesaurus Property-2)
C0012634 (UMLS CUI-1)
CL.11
Code List
Medical Condition
CL Item
Hypertension (1)
C0020538 (UMLS CUI-1)
CL Item
Angina pectoris (2)
C0002962 (UMLS CUI-1)
CL Item
Myocardial Infarction (3)
C0027051 (UMLS CUI-1)
CL Item
Congestive Heart Failure (4)
C0018802 (UMLS CUI-1)
CL Item
Atrial Fibrillation (5)
C0004238 (UMLS CUI-1)
CL Item
Ventricular Arrhythmia (6)
C0085612 (UMLS CUI-1)
CL Item
Diabetes (7)
C0011849 (UMLS CUI-1)
CL Item
Elevated Fasting Lipid Profile (8)
C0020473 (UMLS CUI-1)
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