ID

6401

Descripción

NSABP Protocol B-40 - Left Ventricular Assessment Form (Form LVA) 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=1B73772A-3FC1-6011-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B73772A-3FC1-6011-E044-0003BA3F9857

Palabras clave

Versiones (3)
  1. 18/12/14 18/12/14 - Martin Dugas
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 5/7/15 5/7/15 -
Subido en

18 de diciembre de 2014

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00408408 Follow-Up - NSABP Protocol B-40 - Left Ventricular Assessment Form (Form LVA) - 2511564v1.0

Inglés

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 formularios  
Unnamed1
Descripción

Unnamed1

Patient Initials (Last First Middle)
Descripción

PatientInitialsName

Tipo de datos

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
Descripción

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Tipo de datos

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
Descripción

Unnamed2

Institution/Affiliate
Descripción

CombinedInstitutionName

Tipo de datos

text

Person Completing Form, Last Name
Descripción

ResponsiblePersonLastName

Tipo de datos

text

Person Completing Form, First Name
Descripción

ResponsiblePersonFirstName

Tipo de datos

text

Person Completing Form, Phone
Descripción

ResponsiblePersonPhoneNumber

Tipo de datos

text

Date Form Completed
Descripción

FormCompleteDate

Tipo de datos

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
Descripción

DataAmendedInd-3

Tipo de datos

text

Unnamed3
Descripción

Unnamed3

Patients assigned to Group 1A, 2A, or 3A (Time point)
Descripción

PatientProtocolTreatmentArmAssessmentNationalSurgicalAdjuvantBreastandBowelProjectB-40GroupAType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C15538
UMLS 2011AA Property
C1522541
Patients assigned to Group 1B, 2B, or 3B (Time point)
Descripción

PatientProtocolTreatmentArmAssessmentNationalSurgicalAdjuvantBreastandBowelProjectB-40GroupBType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C15538
UMLS 2011AA Property
C1522541
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Metathesaurus ValueDomain
C0441836
Was LVEF assessment performed at this time point
Descripción

LeftVentricularEjectionFractionAssessmentInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
Unnamed5
Descripción

Unnamed5

Date of Assessment
Descripción

AssessmentPerformedDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Method of Evaluation
Descripción

AssessmentMethodType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
LVEF Patient Value
Descripción

HeartLVEFTestPercentageValue

Tipo de datos

double

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
LVEF Institutional Lower Limit of Normal
Descripción

HeartLVEFTestPercentageLowerLimitofNormalValue

Tipo de datos

double

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
%
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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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 Group
Unnamed3
Item
Patients assigned to Group 1A, 2A, or 3A (Time point)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C15538 (NCI Thesaurus Property)
C1522541 (UMLS 2011AA Property)
CL.2
Code List
Patients assigned to Group 1A, 2A, or 3A (Time point)
CL Item
18 Months After Study Entry (18 months after study entry)
CL Item
3-4 Weeks After Last Chemotherapy Dose (3-4 weeks after last chemotherapy dose)
CL Item
3-5 Weeks After Surgery (3-5 weeks after surgery)
CL Item
After 4 Post-operative Doses Of Bevacizumab (After 4 post-operative doses of bevacizumab)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Other Time Point During First Two Years Following Study Entry (Other time point during first two years following study entry)
Item
Patients assigned to Group 1B, 2B, or 3B (Time point)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C15538 (NCI Thesaurus Property)
C1522541 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0441836 (NCI Metathesaurus ValueDomain)
CL.3
Code List
Patients assigned to Group 1B, 2B, or 3B (Time point)
CL Item
18 Months After Study Entry (18 months after study entry)
CL Item
3-4 Weeks After Last Chemotherapy Dose (3-4 weeks after last chemotherapy dose)
CL Item
3-5 Weeks After Surgery (3-5 weeks after surgery)
CL Item
After 4 Post-operative Doses Of Bevacizumab (After 4 post-operative doses of bevacizumab)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Other Time Point During First Two Years Following Study Entry (Other time point during first two years following study entry)
Item
Was LVEF assessment performed at this time point
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
CL.4
Code List
Was LVEF assessment performed at this time point
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed5
AssessmentPerformedDate
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.5
Code List
Method of Evaluation
CL Item
Echocardiogram (Echocardiogram)
C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)
CL Item
Muga Scan (MUGA)
HeartLVEFTestPercentageValue
Item
LVEF Patient Value
double
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal
double
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
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