ID

1464

Description

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

Keywords

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

August 27, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT00499369 Registration - Southwest Oncology Group S0600 Registration Worksheet - 2994609v1.0

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.

Unnamed2
Description

Unnamed2

SWOG Patient ID Status
Description

PatientSouthwestOncologyGroupIdentifierStatus

Data type

text

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

PatientSouthwestOncologyGroupIdentifierNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25699
UMLS 2011AA Property
C1519429
Unnamed5
Description

Unnamed5

Patient First Name
Description

PatientFirstName

Data type

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
C25509
UMLS 2011AA Property
C1279901
Patient Middle Name
Description

PatientMiddleName

Data type

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
C25569
UMLS 2011AA Property
C0444598
Patient Last Name
Description

PatientLastName

Data type

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
C25551
UMLS 2011AA Property
C1517741
Unnamed4
Description

Unnamed4

Registrar's SWOG Roster ID Number
Description

RegistrarSouthwestOncologyGroupIdentifierNumber

Data type

text

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

SouthwestOncologyGroupInvestigatorIdentifierNumber

Data type

double

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
C17089
UMLS 2011AA ObjectClass
C0035173
SWOG Treating Institution Number
Description

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Data type

double

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

Patient Information

Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
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)
Description

ProtocolPrivacyApprovedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Projected Start Date of Treatment
Description

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Stratification Questions
Description

Stratification Questions

Performance status
Description

PerformanceStatusAssessmentPerformanceStatusStratificationCode

Data type

double

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

OxaliplatinFirst-LineTherapyDiscontinueCode

Data type

double

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
C45792
UMLS 2011AA ObjectClass
C1708063
Planned concurrent chemotherapy
Description

ClinicalStudyProtocolConcurrentChemotherapyPlanStratificationCode

Data type

text

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

ClinicalStudyProtocolBevacizumabLastAdministrationStratificationDuration

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property
C25689
UMLS 2011AA Property
C1514983
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
Unnamed4
Description

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
Description

SouthwestOncologyGroupPatientResearchConsentInd-2

Data type

text

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

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
Description

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Data type

text

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

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.

Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
C1519429 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
SWOG Patient ID Status
CL Item
New Patient (New patient)
CL Item
Previous Patient (Previous patient)
PatientSouthwestOncologyGroupIdentifierNumber
Item
SWOG Patient ID
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
Item Group
Unnamed5
PatientFirstName
Item
Patient First 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)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
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)
C0444598 (UMLS 2011AA Property)
PatientLastName
Item
Patient Last 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)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
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)
C1519429 (UMLS 2011AA Property)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS 2011AA ObjectClass)
SouthwestOncologyGroupInvestigatorIdentifierNumber
Item
SWOG Investigator Number
double
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)
C0035173 (UMLS 2011AA ObjectClass)
SouthwestOncologyGroupTreatingInstitutionIdentifierNumber
Item
SWOG Treating Institution Number
double
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
C41206 (NCI Thesaurus ObjectClass)
C1272753 (UMLS 2011AA ObjectClass)
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)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
ProtocolPrivacyApprovedDate
Item
Date HIPAA Authorization signed (Not required if Country of Residence is not USA)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
Item Group
Stratification Questions
Item
Performance status
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus ValueDomain)
C1514983 (UMLS 2011AA ValueDomain)
Code List
Performance status
CL Item
0 (1)
CL Item
>=1 (2)
Item
Discontinuation of oxaliplatin while on first line therapy
double
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)
C1708063 (UMLS 2011AA ObjectClass)
Code List
Discontinuation of oxaliplatin while on first line therapy
CL Item
Yes (1)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (2)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1301732 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
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)
C1517741 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
Code List
Time from last dose of bevacizumab
CL Item
14-42 Days (1)
CL Item
43 Days Or Higher (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
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
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
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Patient Eligibility
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
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
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
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

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