ID

9443

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

Lien

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

Mots-clés

Versions (2)
  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le

9 janvier 2015

DOI

Pour une demande vous connecter.

Licence

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

Anglais

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 Formulaires  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Type de données

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

Type de données

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
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

Type de données

float

Unités de mesure
  • mm
Alias
NCI Thesaurus ObjectClass
C4809
UMLS 2011AA ObjectClass
C0543478
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property-2
C0600558
NCI Thesaurus Property-3
C25483
UMLS 2011AA Property-3
C0439534
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25558
UMLS 2011AA ValueDomain-2
C1522425
mm
Primary Tumor Bed Area
Description

ResidualDiseasePostNeoadjuvantTherapyDimensionLongestPerpendicularAxisMeasurement

Type de données

float

Unités de mesure
  • mm
Alias
NCI Thesaurus ObjectClass
C4809
UMLS 2011AA ObjectClass
C0543478
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property-2
C0600558
NCI Thesaurus Property-3
C25483
UMLS 2011AA Property-3
C0439534
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25558
UMLS 2011AA ValueDomain-2
C1522425
NCI Thesaurus ValueDomain-3
C54649
UMLS 2011AA ValueDomain-3
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

Type de données

float

Unités de mesure
  • %
Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property-2
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

Type de données

float

Unités de mesure
  • %
Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C14160
UMLS 2011AA Property-2
C0444498
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ValueDomain-2
C25613
UMLS 2011AA ValueDomain-2
C0439165
NCI Thesaurus ValueDomain-3
C19157
UMLS 2011AA ValueDomain-3
C0370003
NCI Thesaurus ValueDomain-4
C25712
UMLS 2011AA ValueDomain-4
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

Type de données

float

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

Type de données

float

Alias
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass-2
C12947
UMLS 2011AA ObjectClass-2
C1522495
NCI Thesaurus ObjectClass-3
C12904
UMLS 2011AA ObjectClass-3
C0729594
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C14174
UMLS 2011AA Property-3
C0036525
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Units
Description

LesionDiameterUOM

Type de données

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

Research Comments

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
Description

Person Completing Form

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Description

Date Form Completed

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
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.)
float
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
C25483 (NCI Thesaurus Property-3)
C0439534 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25558 (NCI Thesaurus ValueDomain-2)
C1522425 (UMLS 2011AA ValueDomain-2)
ResidualDiseasePostNeoadjuvantTherapyDimensionLongestPerpendicularAxisMeasurement
Item
Primary Tumor Bed Area
float
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
C25483 (NCI Thesaurus Property-3)
C0439534 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25558 (NCI Thesaurus ValueDomain-2)
C1522425 (UMLS 2011AA ValueDomain-2)
C54649 (NCI Thesaurus ValueDomain-3)
C1295725 (UMLS 2011AA ValueDomain-3)
InvasiveBreastCarcinomaExtentNumber
Item
Overall Cancer Cellularity (Estimate of proportion of residual tumor bed area that is involved by cancer. If no residual tumor, % = 0)
float
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
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)
float
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C14160 (NCI Thesaurus Property-2)
C0444498 (UMLS 2011AA Property-2)
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C25613 (NCI Thesaurus ValueDomain-2)
C0439165 (UMLS 2011AA ValueDomain-2)
C19157 (NCI Thesaurus ValueDomain-3)
C0370003 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)
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.)
float
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)
float
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass-2)
C1522495 (UMLS 2011AA ObjectClass-2)
C12904 (NCI Thesaurus ObjectClass-3)
C0729594 (UMLS 2011AA ObjectClass-3)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C14174 (NCI Thesaurus Property-3)
C0036525 (UMLS 2011AA Property-3)
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
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
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)
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