ID

10084

Description

S1011 Pre-Randomization Off-Study Form (#52060) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer NCT01224665 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9399F2B7-7E68-06C0-E040-BB89AD436952

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9399F2B7-7E68-06C0-E040-BB89AD436952

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 3/24/15 3/24/15 - Martin Dugas
Uploaded on

March 24, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Bladder Cancer NCT01224665

English

Instructions: For registration step 1, submit this form within 2 weeks after going off study, if patient is off study without randomization to extended vs. standard LND. List treatments that the patient received. Systemic Therapy: List regimens, start and end dates. For multidrug regimens, do not list individual drugs separately; end date would be the date all drugs in the regimen were discontinued. Surgery: List type of surgery, and in the "end date" column, the date of surgery. Radiation: List sites, start and end dates (inclusive of boosts and implants)

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
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
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
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Treatment Information
Description

Treatment Information

Alias
UMLS CUI-1
C0087111
Did the patient receive any treatment (on this registration step)
Description

ProtocolTreatmentAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
NCI Thesaurus Property
C25382
UMLS CUI-1
C0087111
Treatment Start Date (MM DD YYYY)
Description

Treatment Begin Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Treatment End Date (MM DD YYYY)
Description

Treatment End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1531784
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
Regimen or Procedure or Site(s)
Description

ProcedureLocationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C25218
UMLS 2011AA ObjectClass
C1948041
Off Treatment Reason
Description

Off Treatment Reason

Alias
UMLS CUI-1
C1518544
UMLS CUI-2
C0566251
Off Study Reason (select one)
Description

Off Study Reason (select one)

Data type

text

Alias
NCI Thesaurus ObjectClass
C25196
NCI Thesaurus ObjectClass-2
C25601
NCI Thesaurus ObjectClass-3
C25629
NCI Thesaurus Property
C25365
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
UMLS CUI-2
C0566251
Adverse event/side effects/complications specify
Description

Off-TreatmentAdverseEventReasonSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus Property-2
C41331
UMLS 2011AA Property-2
C0877248
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
Patient withdrawal/refusal, specify
Description

Off-TreatmentPatientReasonSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus Property-2
C16960
UMLS 2011AA Property-2
C0030705
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
Sites
Description

Off-TreatmentDiseaseProgressionAnatomicSiteSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C13717
UMLS 2011AA Property
C1515974
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C17747
UMLS 2011AA ObjectClass-2
C0242656
Other specify
Description

Off Treatment Reason, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Off Study Date (MM DD YYYY Date of progression, death or decision to discontinue)
Description

Off-TreatmentStudyFollow-UpEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C15206
UMLS 2011AA ObjectClass-2
C0008972
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Additional Treatment
Description

Additional Treatment

Alias
UMLS CUI-1
C1706712
Will patient receive further treatment?
Description

FurtherTreatmentAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25519
UMLS 2011AA ObjectClass
C1517331
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Yes, specify
Description

FurtherTreatmentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25519
UMLS 2011AA ObjectClass
C1517331
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Vital Status
Description

Vital Status

Alias
UMLS CUI-1
C1148433
Date of Last Contact or Death (MM DD YYYY)
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
Vital Status
Description

Vital Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
UMLS CUI-1
C3846084
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Similar models

Instructions: For registration step 1, submit this form within 2 weeks after going off study, if patient is off study without randomization to extended vs. standard LND. List treatments that the patient received. Systemic Therapy: List regimens, start and end dates. For multidrug regimens, do not list individual drugs separately; end date would be the date all drugs in the regimen were discontinued. Surgery: List type of surgery, and in the "end date" column, the date of surgery. Radiation: List sites, start and end dates (inclusive of boosts and implants)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
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)
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)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Treatment Information
C0087111 (UMLS CUI-1)
Treatment
Item
Did the patient receive any treatment (on this registration step)
boolean
C38148 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0087111 (UMLS CUI-1)
Treatment Begin Date
Item
Treatment Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
Treatment End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
ProcedureLocationText
Item
Regimen or Procedure or Site(s)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ObjectClass)
C1948041 (UMLS 2011AA ObjectClass)
Item Group
Off Treatment Reason
C1518544 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
Item
Off Study Reason (select one)
text
C25196 (NCI Thesaurus ObjectClass)
C25601 (NCI Thesaurus ObjectClass-2)
C25629 (NCI Thesaurus ObjectClass-3)
C25365 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
CL.2
Code List
Off Study Reason (select one)
CL Item
Ineligible For Randomization To Extended Vs. Standard Lnd Due To Extent Of Disease At The Time Of Surgery (1)
CL Item
Adverse Event/side Effects/complications (2)
CL Item
Patient Withdrawal/refusal (3)
CL Item
Disease Progression (4)
CL Item
Death On Study (5)
CL Item
Other (6)
Off-TreatmentAdverseEventReasonSpecify
Item
Adverse event/side effects/complications specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property-2)
C0877248 (UMLS 2011AA Property-2)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
Off-TreatmentPatientReasonSpecify
Item
Patient withdrawal/refusal, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C16960 (NCI Thesaurus Property-2)
C0030705 (UMLS 2011AA Property-2)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
Off-TreatmentDiseaseProgressionAnatomicSiteSpecify
Item
Sites
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass-2)
C0242656 (UMLS 2011AA ObjectClass-2)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Off-TreatmentStudyFollow-UpEndDate
Item
Off Study Date (MM DD YYYY Date of progression, death or decision to discontinue)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Additional Treatment
C1706712 (UMLS CUI-1)
Item
Will patient receive further treatment?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25519 (NCI Thesaurus ObjectClass-2)
C1517331 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.3
Code List
Will patient receive further treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
FurtherTreatmentSpecify
Item
Yes, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25519 (NCI Thesaurus ObjectClass-2)
C1517331 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Vital Status
C1148433 (UMLS CUI-1)
Date last contact
Item
Date of Last Contact or Death (MM DD YYYY)
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
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
C3846084 (UMLS CUI-1)
CL.4
Code List
Vital Status
CL Item
Alive (Alive)
C2584946 (UMLS CUI-1)
CL Item
Dead (Dead)
C0011065 (UMLS CUI-1)
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