ID

8978

Descripción

Southwest Oncology Group S0600 Registration Worksheet Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E16B1D7-6F02-2C29-E040-BB89AD4317D7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E16B1D7-6F02-2C29-E040-BB89AD4317D7

Palabras clave

Versiones (2)
  1. 27/8/12 27/8/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
Subido en

9 de enero de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT00499369 Registration - Southwest Oncology Group S0600 Registration Worksheet - 2994609v1.0

Inglés

INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

1 formularios  
Unnamed2
Descripción

Unnamed2

SWOG Patient ID Status
Descripción

PatientSouthwestOncologyGroupIdentifierStatus

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25699
UMLS 2011AA Property-2
C1519429
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
SWOG Patient ID
Descripción

Trial subject ID SWOG

Tipo de datos

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
Unnamed5
Descripción

Unnamed5

Patient First Name
Descripción

First Name

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1443235
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
Patient Middle Name
Descripción

PatientMiddleName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Patient Last Name
Descripción

Last Name

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301584
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
Unnamed4
Descripción

Unnamed4

Registrar's SWOG Roster ID Number
Descripción

RegistrarSouthwestOncologyGroupIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25699
UMLS 2011AA Property-2
C1519429
NCI Thesaurus ObjectClass
C25357
UMLS 2011AA ObjectClass
C0557514
SWOG Investigator Number
Descripción

SouthwestOncologyGroupInvestigatorIdentifierNumber

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25699
UMLS 2011AA ObjectClass
C1519429
NCI Thesaurus ObjectClass-2
C17089
UMLS 2011AA ObjectClass-2
C0035173
SWOG Treating Institution Number
Descripción

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25699
UMLS 2011AA ObjectClass
C1519429
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
NCI Thesaurus ObjectClass-3
C41206
UMLS 2011AA ObjectClass-3
C1272753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient Information
Descripción

Patient Information

Date Informed Consent Signed
Descripción

InformedConsentFormSignedDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Date HIPAA Authorization signed (Not required if Country of Residence is not USA)
Descripción

HIPAA Approval Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0600593
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2346844
NCI Thesaurus Property
C25425
Projected Start Date of Treatment
Descripción

Treatment Begin Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Stratification Questions
Descripción

Stratification Questions

Performance status
Descripción

PerformanceStatusAssessmentPerformanceStatusStratificationCode

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain-2
C25689
UMLS 2011AA ValueDomain-2
C1514983
Discontinuation of oxaliplatin while on first line therapy
Descripción

OxaliplatinFirst-LineTherapyDiscontinueCode

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C1181
UMLS 2011AA ObjectClass
C0069717
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus ObjectClass-2
C45792
UMLS 2011AA ObjectClass-2
C1708063
Planned concurrent chemotherapy
Descripción

ClinicalStudyProtocolConcurrentChemotherapyPlanStratificationCode

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C25619
UMLS 2011AA Property-2
C1301732
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25689
UMLS 2011AA Property-4
C1514983
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Time from last dose of bevacizumab
Descripción

ClinicalStudyProtocolBevacizumabLastAdministrationStratificationDuration

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property-2
C25551
UMLS 2011AA Property-2
C1517741
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus Property-4
C25689
UMLS 2011AA Property-4
C1514983
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
Unnamed4
Descripción

Unnamed4

I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
Descripción

SouthwestOncologyGroupPatientResearchConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25699
UMLS 2011AA ObjectClass-2
C1519429
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient Eligibility
Descripción

Patient Eligibility

Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0
Descripción

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25699
UMLS 2011AA ObjectClass-2
C1519429
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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Similar models

INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Unnamed2
Item
SWOG Patient ID Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.1
Code List
SWOG Patient ID Status
CL Item
New Patient (New patient)
CL Item
Previous Patient (Previous patient)
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)
Item Group
Unnamed5
First Name
Item
Patient First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleName
Item
Patient Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Last Name
Item
Patient Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Item Group
Unnamed4
RegistrarSouthwestOncologyGroupIdentifierNumber
Item
Registrar's SWOG Roster ID Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS 2011AA ObjectClass)
SouthwestOncologyGroupInvestigatorIdentifierNumber
Item
SWOG Investigator Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
SouthwestOncologyGroupTreatingInstitutionIdentifierNumber
Item
SWOG Treating Institution Number
float
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Item Group
Patient Information
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HIPAA Approval Date
Item
Date HIPAA Authorization signed (Not required if Country of Residence is not USA)
date
C25164 (NCI Thesaurus ValueDomain)
C0600593 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2346844 (UMLS CUI-2)
C25425 (NCI Thesaurus Property)
Treatment Begin Date
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Item Group
Stratification Questions
PerformanceStatusAssessmentPerformanceStatusStratificationCode
Item
Performance status
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus ValueDomain-2)
C1514983 (UMLS 2011AA ValueDomain-2)
OxaliplatinFirst-LineTherapyDiscontinueCode
Item
Discontinuation of oxaliplatin while on first line therapy
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C1181 (NCI Thesaurus ObjectClass)
C0069717 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C45792 (NCI Thesaurus ObjectClass-2)
C1708063 (UMLS 2011AA ObjectClass-2)
Item
Planned concurrent chemotherapy
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25689 (NCI Thesaurus Property-4)
C1514983 (UMLS 2011AA Property-4)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
CL.4
Code List
Planned concurrent chemotherapy
CL Item
Irinotecan + 5-fluorouracil/leucovorin Regimen (folfiri) (1)
CL Item
Single Agent Irinotecan (2)
Item
Time from last dose of bevacizumab
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C25689 (NCI Thesaurus Property-4)
C1514983 (UMLS 2011AA Property-4)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
CL.5
Code List
Time from last dose of bevacizumab
CL Item
14-42 Days (1)
CL Item
43 Days Or Higher (2)
SouthwestOncologyGroupPatientResearchConsentInd-2
Item
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Patient Eligibility
SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2
Item
Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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