ID

7314

Description

S1007 Supplementary Follow-Up Form (FUS1007) Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90C9DFFB-2463-84DB-E040-BB89AD437DC2

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90C9DFFB-2463-84DB-E040-BB89AD437DC2

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01272037 Follow-Up - S1007 Supplementary Follow-Up Form (FUS1007) - 3139763v1.0

English

Instructions: Please submit at each follow up after completion of treatment until recurrence, at time of recurrence, and at protocol specified intervals after recurrence. All dates are MONTH, DAY, YEAR. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form

1 forms  
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Date of Evaluation (MM DD YYYY)
Description

LesionAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Iib - Local-regional Recurrence
Description

Iib - Local-regional Recurrence

Has the patient been diagnosed with a new invasive primary or recurrence in the opposite breast (contralateral since submission of last follow-up form)
Description

ContralateralBreastNewCancerDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C9305
UMLS 2011AA ObjectClass-3
C0006826
NCI Thesaurus ObjectClass-4
C25307
UMLS 2011AA ObjectClass-4
C0441988
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of diagnosis (MM DD YYYY)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Has the patient been diagnosed with first local-regional recurrence or progression (do not include DCIS since submission of last follow-up form)
Description

RecurrentDiseaseCancerProgressionFirstLocal-RegionalDiagnosisIndicator

Data type

boolean

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 Property-4
C19987
UMLS 2011AA Property-4
C0242656
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date of First Local-Regional Recurrence (MM DD YYYY)
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 of first local-regional recurrence (s select all that apply)
Description

BreastCarcinomaLocal-RegionalRecurrentDiseaseAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25388
UMLS 2011AA Property
C1947913
NCI Thesaurus Property-2
C38155
UMLS 2011AA Property-2
C0277556
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
How was this progression information obtained?
Description

ProgressionAssessmentSource

Data type

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
Iic - Distance Recurrence
Description

Iic - Distance Recurrence

Has the patient been diagnosed with first distant recurrence/progression? (since submission of 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 Progression (MM DD YYYY)
Description

Date of Neoplasm distal recurrence

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0027627
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain-2
C25509
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Site of First Distant Progression (s select all that apply)
Description

DistantProgressionFirstSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Other, NOS
Description

RecurrentDiseaseFirstDistantDiagnosisSpecify

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
C25685
UMLS 2011AA ValueDomain
C1521902
How was this progression information obtained?
Description

ProgressionAssessmentSource

Data type

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Instructions: Please submit at each follow up after completion of treatment until recurrence, at time of recurrence, and at protocol specified intervals after recurrence. All dates are MONTH, DAY, YEAR. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Date of Evaluation (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Iib - Local-regional Recurrence
ContralateralBreastNewCancerDiagnosisInd-2
Item
Has the patient been diagnosed with a new invasive primary or recurrence in the opposite breast (contralateral since submission of last follow-up form)
boolean
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C25307 (NCI Thesaurus ObjectClass-4)
C0441988 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NewCancerDiagnosisDate
Item
Date of diagnosis (MM DD YYYY)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
RecurrentDiseaseCancerProgressionFirstLocal-RegionalDiagnosisIndicator
Item
Has the patient been diagnosed with first local-regional recurrence or progression (do not include DCIS since submission of last follow-up form)
boolean
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)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
RecurrentDiseaseFirstLocal-RegionalDiagnosisDate
Item
Date of First Local-Regional Recurrence (MM DD YYYY)
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 of first local-regional recurrence (s select all that apply)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
CL.3
Code List
Site of first local-regional recurrence (s select all that apply)
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Axillary Nodes (Axillary nodes)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Internal Mammary Nodes (Internal mammary nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
CL Item
Axilla (Axilla)
Item
How was this progression information obtained?
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
CL.7
Code List
How was this progression information obtained?
CL Item
Clinical Assessment (Clinical assessment)
CL Item
Patient Self Report Only (Patient self-report only)
Item Group
Iic - Distance Recurrence
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant recurrence/progression? (since submission of 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)
Date of Neoplasm distal recurrence
Item
Date of First Distant Progression (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item
Site of First Distant Progression (s select all that apply)
text
C25331 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus ObjectClass-2)
C0443203 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.6
Code List
Site of First Distant Progression (s select all that apply)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Other Cns (Other CNS)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Nodes (Nodes)
CL Item
Other Soft Tissue (Other Soft Tissue)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other Visceral (Other Visceral)
CL Item
Other Nos (Other NOS)
RecurrentDiseaseFirstDistantDiagnosisSpecify
Item
Other, NOS
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)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
How was this progression information obtained?
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
CL.7
Code List
How was this progression information obtained?
CL Item
Clinical Assessment (Clinical assessment)
CL Item
Patient Self Report Only (Patient self-report only)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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