ID

6397

Descrição

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

Palavras-chave

Versões (3)
  1. 18/12/2014 18/12/2014 - Martin Dugas
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 01/04/2015 01/04/2015 - Martin Dugas
Transferido a

18 de dezembro de 2014

DOI

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Licença

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

Inglês

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 Formulários  
Unnamed1
Descrição

Unnamed1

Patient Initials (Last First Middle)
Descrição

PatientInitialsName

Tipo de dados

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
NSABP Patient ID
Descrição

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Unnamed2
Descrição

Unnamed2

Institution/Affiliate
Descrição

CombinedInstitutionName

Tipo de dados

text

Person Completing Form, Last Name
Descrição

ResponsiblePersonLastName

Tipo de dados

text

Person Completing Form, First Name
Descrição

ResponsiblePersonFirstName

Tipo de dados

text

Person Completing Form, Phone
Descrição

ResponsiblePersonPhoneNumber

Tipo de dados

text

Date Form Completed
Descrição

FormCompleteDate

Tipo de dados

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
Are data amended
Descrição

DataAmendedInd-3

Tipo de dados

text

Tumor Laterality
Descrição

PrimaryTumorLateralityType

Tipo de dados

text

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

Unnamed3

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

BreastTumorHistologicCategory

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
Other specify
Descrição

TumorHistologicCategorySpecify

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Receptor Status, ER (from diagnostic core needle biopsy)
Descrição

ERLevelTumorStatus

Tipo de dados

text

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

PgRStatusType

Tipo de dados

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.)
Descrição

BreastTumorHistologicGrade

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Was HER-2/neu status determined
Descrição

EpidermalGrowthFactorReceptorAssessmentInd-2

Tipo de dados

text

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 - )
Descrição

HER2/neuStatusType

Tipo de dados

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
Descrição

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.)
Descrição

FirstDegreeRelativeCardiovascularDisorderDeathInd-2

Tipo de dados

text

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

Unnamed6

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

MedicationPriorMedicalConditionReceivedInd-2

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Medical Condition
Descrição

PatientMedicalConditionCurrentType

Tipo de dados

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
C25457
UMLS 2011AA Property
C0348080
Medications (in the 12 months prior to study entry)
Descrição

MedicationPriorReceivedInd-2

Tipo de dados

text

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
C25639
UMLS 2011AA Property
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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Unnamed1
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)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
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
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)
Item
Are data amended
text
CL.1
Code List
Are data amended
CL Item
No (no)
CL Item
Yes (yes)
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
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)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
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)
C0205417 (UMLS 2011AA)
CL Item
Other Specify (Other)
TumorHistologicCategorySpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
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)
C0449438 (UMLS 2011AA ValueDomain)
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)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
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))
Item
Was HER-2/neu status determined
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C17068 (NCI Thesaurus ObjectClass)
C0034802 (UMLS 2011AA ObjectClass)
CL.7
Code List
Was HER-2/neu status determined
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
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.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C2931 (NCI Thesaurus Property)
C0007222 (UMLS 2011AA Property)
C21481 (NCI Thesaurus ObjectClass)
C1517194 (UMLS 2011AA ObjectClass)
CL.9
Code List
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.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed6
Item
Did the patient take medications for any of the following medical conditions in the 12 months prior to study entry
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
Did the patient take medications for any of the following medical conditions in the 12 months prior to study entry
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0348080 (UMLS 2011AA Property)
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)
Item
Medications (in the 12 months prior to study entry)
text
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)
C1514756 (UMLS 2011AA Property)
CL.12
Code List
Medications (in the 12 months prior to study entry)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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