ID

950

Description

NSABP Protocol B-40 - Worksheet for Calculation of Residual Cancer Burden 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=47C6C52F-D25C-1865-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=47C6C52F-D25C-1865-E044-0003BA3F9857

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
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August 26, 2012

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00408408 Pathology - NSABP Protocol B-40 - Worksheet for Calculation of Residual Cancer Burden - 2734029v1.0

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  
Unnamed1
Description

Unnamed1

Patient Initials (Last First Middle)
Description

PatientInitialsName

Data type

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
Description

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Data type

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
Items Related To Calculation Of Residual Cancer Burden
Description

Items Related To Calculation Of Residual Cancer Burden

Primary Tumor Bed Area (Identification of cross-sectional dimensions of residual bed, considering gross and adjacent microscopic tumor. If no residual tumor, measurements = 0.)
Description

ResidualDiseasePostNeoadjuvantTherapyDimensionLongestMeasurement

Data type

double

Measurement units
  • mm
Alias
NCI Thesaurus ObjectClass
C4809
UMLS 2011AA ObjectClass
C0543478
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C15665
UMLS 2011AA Property
C0600558
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain
C25558
UMLS 2011AA ValueDomain
C1522425
mm
Primary Tumor Bed Area
Description

ResidualDiseasePostNeoadjuvantTherapyDimensionLongestPerpendicularAxisMeasurement

Data type

double

Measurement units
  • mm
Alias
NCI Thesaurus ObjectClass
C4809
UMLS 2011AA ObjectClass
C0543478
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C15665
UMLS 2011AA Property
C0600558
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain
C25558
UMLS 2011AA ValueDomain
C1522425
NCI Thesaurus ValueDomain
C54649
UMLS 2011AA ValueDomain
C1295725
mm
Overall Cancer Cellularity (Estimate of proportion of residual tumor bed area that is involved by cancer. If no residual tumor, % = 0)
Description

InvasiveBreastCarcinomaExtentNumber

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass
C14159
UMLS 2011AA ObjectClass
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property
C25527
UMLS 2011AA Property
C0205462
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
%
Percentage of Cancer that is in situ Disease (Estimate of the proportion of residual tumor bed area that is in situ component. If no residual tumor, % = 0)
Description

BreastCarcinomaInSituTumorPercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C14160
UMLS 2011AA Property
C0444498
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C19157
UMLS 2011AA ValueDomain
C0370003
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Number of Positive Lymph Nodes (Consider axillary nodes from applicable post-neoadjuvant procedures: sentinel node biopsy and/or surgical evaluation of axilla. If no positive axillary nodes, number = 0.)
Description

LymphNodePositiveCount

Data type

double

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Diameter of largest metastasis (Consider axillary nodes from applicable post-neoadjuvant procedures: sentinel node biopsy and/or surgical evaluation of axilla. If no positive axillary nodes, largest metastasis = 0)
Description

AxillarySentinelLymphNodeLongestMetastaticDiameterMeasurement

Data type

double

Alias
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property
C25558
UMLS 2011AA Property
C1522425
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Units
Description

LesionDiameterUOM

Data type

text

Alias
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Footer
Description

Footer

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Person Completing Form
Description

ResponsiblePersonName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed
Description

FormCompleteDate

Data type

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
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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
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
Items Related To Calculation Of Residual Cancer Burden
ResidualDiseasePostNeoadjuvantTherapyDimensionLongestMeasurement
Item
Primary Tumor Bed Area (Identification of cross-sectional dimensions of residual bed, considering gross and adjacent microscopic tumor. If no residual tumor, measurements = 0.)
double
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
ResidualDiseasePostNeoadjuvantTherapyDimensionLongestPerpendicularAxisMeasurement
Item
Primary Tumor Bed Area
double
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C54649 (NCI Thesaurus ValueDomain)
C1295725 (UMLS 2011AA ValueDomain)
InvasiveBreastCarcinomaExtentNumber
Item
Overall Cancer Cellularity (Estimate of proportion of residual tumor bed area that is involved by cancer. If no residual tumor, % = 0)
double
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
BreastCarcinomaInSituTumorPercentageValue
Item
Percentage of Cancer that is in situ Disease (Estimate of the proportion of residual tumor bed area that is in situ component. If no residual tumor, % = 0)
double
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C14160 (NCI Thesaurus Property)
C0444498 (UMLS 2011AA Property)
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ValueDomain)
C0370003 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes (Consider axillary nodes from applicable post-neoadjuvant procedures: sentinel node biopsy and/or surgical evaluation of axilla. If no positive axillary nodes, number = 0.)
double
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
AxillarySentinelLymphNodeLongestMetastaticDiameterMeasurement
Item
Diameter of largest metastasis (Consider axillary nodes from applicable post-neoadjuvant procedures: sentinel node biopsy and/or surgical evaluation of axilla. If no positive axillary nodes, largest metastasis = 0)
double
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item
Units
text
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
CL.1
Code List
Units
CL Item
Millimeters (mm)
Item Group
Footer
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
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)
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