ID

10192

Descrizione

Southwest Oncology Group S0925 Registration Worksheet Form (Step 1) Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer NCT01120236 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=94470DE4-29D5-D339-E040-BB89AD4306AB

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=94470DE4-29D5-D339-E040-BB89AD4306AB

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 25/04/15 25/04/15 - Martin Dugas
Caricato su

25 aprile 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer Registration SWOG S0925 NCT01120236

Inglese

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 moduli  
Header
Descrizione

Header

Activation Date
Descrizione

ClinicalStudyProtocolAmendmentActivationDate

Tipo di dati

date

Unità di misura
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C64382
NCI Thesaurus Property-2
C41200
UMLS CUI-1
C1879547
UMLS CUI-2
C0011008
MM DD YYYY
Last Amended Date (MM DD YYYY)
Descrizione

DataAmendedLastDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain-2
C25551
UMLS 2011AA ValueDomain-2
C1517741
Registration Step
Descrizione

Registration Number

Tipo di dati

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
Swog Patient Id
Descrizione

Swog Patient Id

SWOG Patient ID Status
Descrizione

PatientSouthwestOncologyGroupIdentifierStatus

Tipo di dati

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
NCI Thesaurus ValueDomain
C25688
UMLS CUI-1
C1519429
UMLS CUI-2
C0600091
SWOG Patient ID
Descrizione

Trial subject ID SWOG

Tipo di dati

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
Demography
Descrizione

Demography

Patient First Name
Descrizione

First Name

Tipo di dati

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
Descrizione

PatientMiddleName

Tipo di dati

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
Descrizione

Last Name

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301584
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
FOR SWOG INSTITUTIONS
Descrizione

FOR SWOG INSTITUTIONS

Registrar's SWOG Roster ID Number
Descrizione

RegistrarSouthwestOncologyGroupIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
NCI Thesaurus ObjectClass
C25357
UMLS CUI-1
C0557514
SWOG Investigator Number
Descrizione

SouthwestOncologyGroupInvestigatorIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C25699
NCI Thesaurus ObjectClass-2
C17089
UMLS CUI-1
C0237753
UMLS CUI-2
C1519429
SWOG Treating Institution Number
Descrizione

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25699
NCI Thesaurus ObjectClass-2
C25705
NCI Thesaurus ObjectClass-3
C41206
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1519429
UMLS CUI-2
C1272753
UMLS CUI-3
C0600091
PATIENT INFORMATION
Descrizione

PATIENT INFORMATION

Alias
UMLS CUI-1
C1955348
Date Informed Consent Signed (MM DD YYYY)
Descrizione

InformedConsentFormSignedDate

Tipo di dati

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 MM DD YYYY)
Descrizione

HIPAA Approval Date

Tipo di dati

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 (MM DD YYYY)
Descrizione

Treatment Begin Date

Tipo di dati

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
Auxiliary Question
Descrizione

Auxiliary Question

Late Induction Registration (i.e. patient has already initiated LHRH agonist therapy and/or anti-androgen therapy prior to registration)
Descrizione

PatientLateInductionRegistrationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C61367
NCI Thesaurus Property-3
C64998
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1514821
UMLS CUI-2
C0205087
Stratification Question
Descrizione

Stratification Question

Most recent PSA (use measurements pre-LHRH agonist therapy in the event patient is a late induction registration)
Descrizione

PatientPSAStratificationCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17525
NCI Thesaurus Property-2
C25689
UMLS CUI-1
C0138741
Performance status
Descrizione

PerformanceStatusAssessmentPerformanceStatusStratificationCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
NCI Thesaurus ValueDomain-2
C25689
UMLS CUI-1
C1518965
Indicate how the patient answered the following questions on the consent form
Descrizione

Indicate how the patient answered the following questions on the consent form

My specimens may be used for the special testing described as part of this study.
Descrizione

SouthwestOncologyGroupPatientSpecimenSpecialConsentIndicator

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25699
NCI Thesaurus Property
C19157
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C25684
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1511481
UMLS CUI-2
C1292533
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.
Descrizione

SouthwestOncologyGroupPatientResearchConsentIndicator

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25699
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
NCI Thesaurus ValueDomain
C25180
Patient Eligibility
Descrizione

Patient Eligibility

Alias
UMLS CUI-1
C1302261
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?
Descrizione

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25699
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C25171
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1302261
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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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header
Protocol activation date
Item
Activation Date
date
C25164 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C64382 (NCI Thesaurus Property)
C41200 (NCI Thesaurus Property-2)
C1879547 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
DataAmendedLastDate
Item
Last Amended Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-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)
Item Group
Swog Patient Id
Item
SWOG Patient ID Status
integer
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C25688 (NCI Thesaurus ValueDomain)
C1519429 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
CL.1
Code List
SWOG Patient ID Status
CL Item
New Patient (1)
CL Item
Previous patient (2)
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
Demography
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
FOR SWOG INSTITUTIONS
Registrar ID
Item
Registrar's SWOG Roster ID Number
text
C25337 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS CUI-1)
SWOG Investigator Number
Item
SWOG Investigator Number
text
C25337 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0237753 (UMLS CUI-1)
C1519429 (UMLS CUI-2)
SWOG Treating Institution Number
Item
SWOG Treating Institution Number
text
C25699 (NCI Thesaurus ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C25364 (NCI Thesaurus Property)
C25337 (NCI Thesaurus ValueDomain)
C1519429 (UMLS CUI-1)
C1272753 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Item Group
PATIENT INFORMATION
C1955348 (UMLS CUI-1)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (MM DD YYYY)
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 MM DD YYYY)
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 (MM DD YYYY)
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
Auxiliary Question
Late Induction Registration
Item
Late Induction Registration (i.e. patient has already initiated LHRH agonist therapy and/or anti-androgen therapy prior to registration)
boolean
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C61367 (NCI Thesaurus Property-2)
C64998 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C0205087 (UMLS CUI-2)
Item Group
Stratification Question
Item
Most recent PSA (use measurements pre-LHRH agonist therapy in the event patient is a late induction registration)
text
C25162 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17525 (NCI Thesaurus Property)
C25689 (NCI Thesaurus Property-2)
C0138741 (UMLS CUI-1)
CL.3
Code List
Most recent PSA (use measurements pre-LHRH agonist therapy in the event patient is a late induction registration)
CL Item
<20 ng/ml (1)
CL Item
>20 ng/ml (2)
Performance status
Item
Performance status
text
C25162 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25689 (NCI Thesaurus ValueDomain-2)
C1518965 (UMLS CUI-1)
Item Group
Indicate how the patient answered the following questions on the consent form
Item
My specimens may be used for the special testing described as part of this study.
text
C16960 (NCI Thesaurus ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C19157 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C25684 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI-1)
C1292533 (UMLS CUI-2)
CL.5
Code List
My specimens may be used for the special testing described as part of this study.
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
CL Item
No (2)
C1298908 (UMLS CUI-1)
CL Item
Not Asked (3)
C1548670 (UMLS CUI-1)
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)
C25699 (NCI Thesaurus ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C25180 (NCI Thesaurus ValueDomain)
CL.5
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 (1)
C1705108 (UMLS CUI-1)
CL Item
No (2)
C1298908 (UMLS CUI-1)
CL Item
Not Asked (3)
C1548670 (UMLS CUI-1)
Item Group
Patient Eligibility
C1302261 (UMLS CUI-1)
patient eligible
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)
C25699 (NCI Thesaurus ObjectClass-2)
C25646 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
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