ID

11478

Beschrijving

NCT00408408 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

Trefwoorden

Versies (3)
  1. 18-12-14 18-12-14 - Martin Dugas
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 05-07-15 05-07-15 -
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5 juli 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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NCT00408408 NSABP Protocol B-40 - Left Ventricular Assessment Form (Form LVA)

Engels

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 Formulieren  
Header
Beschrijving

Header

Patient Initials (Last First Middle)
Beschrijving

Patient Initials

Datatype

text

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

Patient ID NSABP

Datatype

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
Form completed by
Beschrijving

Form completed by

Institution/Affiliate
Beschrijving

CombinedInstitutionName

Datatype

text

Person Completing Form, Last Name
Beschrijving

ResponsiblePersonLastName

Datatype

text

Person Completing Form, First Name
Beschrijving

ResponsiblePersonFirstName

Datatype

text

Person Completing Form, Phone
Beschrijving

ResponsiblePersonPhoneNumber

Datatype

text

Date Form Completed
Beschrijving

Date Form Completed

Datatype

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
Beschrijving

DataAmendedInd-3

Datatype

boolean

Left Ventricular Assessment
Beschrijving

Left Ventricular Assessment

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

PatientProtocolTreatmentArmAssessmentNationalSurgicalAdjuvantBreastandBowelProjectB-40GroupAType

Datatype

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-2
C15538
UMLS 2011AA Property-2
C1522541
Patients assigned to Group 1B, 2B, or 3B (Time point)
Beschrijving

PatientProtocolTreatmentArmAssessmentNationalSurgicalAdjuvantBreastandBowelProjectB-40GroupBType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C15538
UMLS 2011AA Property-2
C1522541
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Metathesaurus ValueDomain
C0441836
Was LVEF assessment performed at this time point
Beschrijving

LeftVentricularEjectionFractionAssessmentInd-2

Datatype

boolean

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
Date of Assessment
Beschrijving

Assessment Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Method of Evaluation
Beschrijving

Evaluation method

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
LVEF Patient Value
Beschrijving

HeartLVEFTestPercentageValue

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
LVEF Institutional Lower Limit of Normal
Beschrijving

HeartLVEFTestPercentageLowerLimitofNormalValue

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Form completed by
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 Group
Left Ventricular Assessment
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-2)
C1522541 (UMLS 2011AA Property-2)
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-2)
C1522541 (UMLS 2011AA Property-2)
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)
LeftVentricularEjectionFractionAssessmentInd-2
Item
Was LVEF assessment performed at this time point
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus 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
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
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