ID

43141

Description

Southwest Oncology Group S0931 Recurrence Assessment Form (Form #46940) Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E26385C-8CD8-C34F-E040-BB89AD434A8D

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E26385C-8CD8-C34F-E040-BB89AD434A8D

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Kidney Cancer NCT01120249 Response - Southwest Oncology Group S0931 Recurrence Assessment Form (Form #46940) - 2998562v1.0

English

Instructions: Please submit at protocol specified intervals and at time of 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 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 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
Clinical Assessment
Description

Clinical Assessment

Has the patient had a documented clinical assessment for this cancer? (during this report period)
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 yes MM DD YYYY)
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
Symptomatic Deterioration
Description

ResponseSymptomaticDeteriorationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25269
UMLS 2011AA Property
C0231220
NCI Thesaurus Property-2
C25751
UMLS 2011AA Property-2
C0868945
Notice Of Recurrence
Description

Notice Of Recurrence

Has the patient been diagnosed with recurrence of disease (during this report period Second primary is not a basis for recurrence. See section 10.1 for acceptable criteria for recurrence)
Description

RecurrentDiseaseFirstDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
Date of First Recurrence (If yes)
Description

RecurrentDiseaseFirstDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
How was recurrence discovered (If yes - select one)
Description

RecurrenceIdentifiedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3352
UMLS 2011AA ObjectClass
C0034897
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
Other, specify
Description

RecurrenceIdentifiedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C3352
UMLS 2011AA ObjectClass
C0034897
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
Site of recurrence (If yes - select all that apply)
Description

RenalCellCarcinomaRecurrentDiseaseSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus ObjectClass
C9385
UMLS 2011AA ObjectClass
C0007134
Explain why (Unknown)
Description

RenalCellCarcinomaRecurrentDiseaseSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus ObjectClass
C9385
UMLS 2011AA ObjectClass
C0007134
Was biopsy performed
Description

BiopsyPerformedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Date of Biopsy (If yes)
Description

Biopsy Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0005558
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15189
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Biopsy Result (If yes)
Description

BiopsyResultType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Other, specify
Description

BiopsyResultSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
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 protocol specified intervals and at time of 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 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 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
Clinical Assessment
Documented clinical assessment for this cancer
Item
Has the patient had a documented clinical assessment for this cancer? (during this report period)
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 yes MM DD YYYY)
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)
ResponseSymptomaticDeteriorationInd-3
Item
Symptomatic Deterioration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
Item Group
Notice Of Recurrence
RecurrentDiseaseFirstDiagnosisInd-3
Item
Has the patient been diagnosed with recurrence of disease (during this report period Second primary is not a basis for recurrence. See section 10.1 for acceptable criteria for recurrence)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
RecurrentDiseaseFirstDiagnosisDate
Item
Date of First Recurrence (If yes)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Item
How was recurrence discovered (If yes - select one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
CL.4
Code List
How was recurrence discovered (If yes - select one)
CL Item
Routine Radiologic Evaluation (Routine radiologic evaluation)
CL Item
Development Of Symptoms (Development of symptoms)
CL Item
Clinical Evaluation (Clinical evaluation)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
RecurrenceIdentifiedSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
Item
Site of recurrence (If yes - select all that apply)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9385 (NCI Thesaurus ObjectClass)
C0007134 (UMLS 2011AA ObjectClass)
CL.5
Code List
Site of recurrence (If yes - select all that apply)
CL Item
Central Nervous System (Central nervous system)
C12438 (NCI Thesaurus)
C3714787 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Recurrent Disease Lymph Node (Lymph node recurrence)
C12745 (NCI Thesaurus)
C0024204 (UMLS 2011AA)
C38155 (NCI Thesaurus-3)
C0277556 (UMLS 2011AA-4)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Organs (Other organs)
CL Item
Renal Bed (Renal bed)
CL Item
Skeletal (Skeletal)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
RenalCellCarcinomaRecurrentDiseaseSpecify
Item
Explain why (Unknown)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9385 (NCI Thesaurus ObjectClass)
C0007134 (UMLS 2011AA ObjectClass)
Item
Was biopsy performed
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
CL.6
Code List
Was biopsy performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Biopsy Date
Item
Date of Biopsy (If yes)
date
C25164 (NCI Thesaurus ValueDomain)
C0005558 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item
Biopsy Result (If yes)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.7
Code List
Biopsy Result (If yes)
CL Item
Benign (Benign)
C14172 (NCI Thesaurus)
C0205183 (UMLS 2011AA)
CL Item
Malignant (Malignant)
C14143 (NCI Thesaurus)
C0205282 (UMLS 2011AA)
CL Item
Atypical/indeterminate (Atypical/indeterminate)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
BiopsyResultSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
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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