ID

9440

Description

NSABP Protocol B-40: Follow-Up 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=1B7E56A5-1088-1102-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7E56A5-1088-1102-E044-0003BA3F9857

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00408408 Follow-Up - NSABP Protocol B-40: Follow-Up Form - 2511785v1.0

This paper worksheet may be completed to faciliate the entry of the information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online.

Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

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

Data type

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
Vital Status
Description

Vital Status

Patient's Vital Status
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death (month day year)
Description

Date last contact

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Source of Survival Information (if alive)
Description

PersonSurvivalInformationSource

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
NCI Thesaurus Property
C48191
UMLS 2011AA Property
C1533716
NCI Thesaurus Property-2
C17177
UMLS 2011AA Property-2
C0038952
Other,
Description

PersonSurvivalInformationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C48191
UMLS 2011AA Property
C1533716
NCI Thesaurus Property-2
C17177
UMLS 2011AA Property-2
C0038952
Primary Cause of Death (if dead)
Description

Primary Cause of Death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe Cause of Death (attach documentation)
Description

Cause of Death, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Was there evidence of recurrence at the time of death
Description

RecurrentDiseaseDeathDiagnosisIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
Type of Evidence (if yes)
Description

RecurrentDiseaseDeathDiagnosisType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
Cancer Follow-up Status
Description

Cancer Follow-up Status

Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)
Description

Documented clinical assessment for this cancer

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
NCI Thesaurus Property
C16033
UMLS CUI-2
C0006826
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25365
Date of Last Clinical Assessment (if applicable)
Description

Follow-Up Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
First Local-regional Recurrence
Description

First Local-regional Recurrence

Has the patient been diagnosed with first local-regional recurrence
Description

Neoplasm Recurrence, locoregional

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027643
NCI Thesaurus Property
C25388
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C38148
Date of First Local-Regional Recurrence (if applicable)
Description

RecurrentDiseaseFirstLocal-RegionalDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25388
UMLS 2011AA Property
C1947913
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
Description

RecurrentDiseaseDiagnosisAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
First Distant Recurrence
Description

First Distant Recurrence

Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form)
Description

Neoplasm recurrence, Distal

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027627
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25180
Date of First Distant Recurrence (if applicable)
Description

RecurrentDiseaseFirstDistantDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site(s) of First Distant Recurrence
Description

RecurrentDiseaseFirstDistantDiagnosisText

Data type

text

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
New Primary Cancer Or Mds
Description

New Primary Cancer Or Mds

Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Description

New primary cancer

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0751623
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C9305
NCI Thesaurus Property
C15220
Date of Diagnosis (if applicable)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Site(s) of New Primary
Description

NewCancerSiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826

Similar models

This paper worksheet may be completed to faciliate the entry of the information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online.

Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (month day year)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Source of Survival Information (if alive)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
C48191 (NCI Thesaurus Property)
C1533716 (UMLS 2011AA Property)
C17177 (NCI Thesaurus Property-2)
C0038952 (UMLS 2011AA Property-2)
Code List
Source of Survival Information (if alive)
CL Item
Documentation Of Hospital Or Clinic Visit (Documentation of hospital or clinic visit)
CL Item
Phone Contact To Patient (Phone contact to patient)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PersonSurvivalInformationSpecify
Item
Other,
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C48191 (NCI Thesaurus Property)
C1533716 (UMLS 2011AA Property)
C17177 (NCI Thesaurus Property-2)
C0038952 (UMLS 2011AA Property-2)
Item
Primary Cause of Death (if dead)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
Code List
Primary Cause of Death (if dead)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe Cause of Death (attach documentation)
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item
Was there evidence of recurrence at the time of death
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Code List
Was there evidence of recurrence at the time of death
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Type of Evidence (if yes)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Code List
Type of Evidence (if yes)
CL Item
Clinical (Clinical)
C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)
CL Item
Autopsy (Autopsy)
C25153 (NCI Thesaurus)
C0004398 (UMLS 2011AA)
Item Group
Cancer Follow-up Status
Documented clinical assessment for this cancer
Item
Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
Follow-Up Date
Item
Date of Last Clinical Assessment (if applicable)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
First Local-regional Recurrence
Neoplasm Recurrence, locoregional
Item
Has the patient been diagnosed with first local-regional recurrence
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
RecurrentDiseaseFirstLocal-RegionalDiagnosisDate
Item
Date of First Local-Regional Recurrence (if applicable)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Code List
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
CL Item
Axillary Nodes (Axillary nodes)
CL Item
Internal Mammary (Internal mammary)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
Item Group
First Distant Recurrence
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form)
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
RecurrentDiseaseFirstDistantDiagnosisDate
Item
Date of First Distant Recurrence (if applicable)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
RecurrentDiseaseFirstDistantDiagnosisText
Item
Site(s) of First Distant Recurrence
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
New Primary Cancer Or Mds
New primary cancer
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
boolean
C25180 (NCI Thesaurus ValueDomain)
C0751623 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
NewCancerDiagnosisDate
Item
Date of Diagnosis (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerSiteText
Item
Site(s) of New Primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)

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