ID

44596

Beskrivning

Southwest Oncology Group Registration Form (S0226) S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer NCT00075764 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3225DE6-8BA0-26CF-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3225DE6-8BA0-26CF-E034-0003BA12F5E7

Nyckelord

Versioner (3)
  1. 2012-08-26 2012-08-26 -
  2. 2015-04-24 2015-04-24 - Martin Dugas
  3. 2021-09-27 2021-09-27 -
Uppladdad den

27 september 2021

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer Registration SWOG S0226 NCT00075764

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: Southwest Oncology Group Registration Form (S0226)
    1. No Instruction available.
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
SWOG Study No.
Beskrivning

SWOGStudyNo.

Datatyp

text

Registration Step
Beskrivning

RegistrationStep

Datatyp

text

Assigned Treatment Arm
Beskrivning

AssignedTreatmentArm

Datatyp

text

Activation Date
Beskrivning

ActivationDate

Datatyp

text

Last Amended Date
Beskrivning

LastAmendedDate

Datatyp

text

Patient's Name
Beskrivning

Patient'sName

Datatyp

text

SWOG Patient ID
Beskrivning

SWOGPatientID

Datatyp

text

Other Group Patient Number
Beskrivning

OtherGroupPatientNumber

Datatyp

text

Participating Group Protocol Number
Beskrivning

ParticipatingGroupProtocolNumber

Datatyp

text

Caller's SWOG Roster ID
Beskrivning

Caller'sSWOGRosterID

Datatyp

text

IRB Approval Date
Beskrivning

IRBApprovalDate

Datatyp

text

SWOG Investigator Number
Beskrivning

SWOGInvestigatorNumber

Datatyp

text

Other Group Investigator Number (OR)
Beskrivning

OtherGroupInvestigatorIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25936
UMLS 2011AA ObjectClass-2
C0035173
NCI Thesaurus ObjectClass-3
C43359
UMLS 2011AA ObjectClass-3
C0441833
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Other Group Investigator Name
Beskrivning

OtherGroupInvestigatorIdentifierName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25936
UMLS 2011AA ObjectClass-2
C0035173
NCI Thesaurus ObjectClass-3
C43359
UMLS 2011AA ObjectClass-3
C0441833
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Other Group Institution Number
Beskrivning

OtherGroupTreatingInstitutionIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
NCI Thesaurus ObjectClass-3
C41206
UMLS 2011AA ObjectClass-3
C1272753
NCI Thesaurus ObjectClass-4
C43359
UMLS 2011AA ObjectClass-4
C0441833
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Other Group Institution Name
Beskrivning

OtherGroupTreatingInstitutionIdentifierName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
NCI Thesaurus ObjectClass-3
C41206
UMLS 2011AA ObjectClass-3
C1272753
NCI Thesaurus ObjectClass-4
C43359
UMLS 2011AA ObjectClass-4
C0441833
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain-2
C21541
UMLS 2011AA ValueDomain-2
C0018704
SWOG Treating Institution Number
Beskrivning

SWOGTreatingInstitutionNumber

Datatyp

text

Date HIPAA Authorization signed
Beskrivning

DateHIPAAAuthorizationsigned

Datatyp

text

Method of Payment
Beskrivning

MethodofPayment

Datatyp

text

Patient Social Security Number
Beskrivning

PatientSocialSecurityNumber

Datatyp

text

Patient's ZIP Code
Beskrivning

Patient'sZIPCode

Datatyp

text

Country of Residence
Beskrivning

CountryofResidence

Datatyp

text

Social Insurance Number
Beskrivning

SocialInsuranceNumber

Datatyp

text

Postal Code
Beskrivning

PostalCode

Datatyp

text

Patient data
Beskrivning

Patient data

Alias
UMLS CUI-1
C2707520
Patient's Date of Birth
Beskrivning

Patient'sDateofBirth

Datatyp

date

Alias
UMLS CUI-1
C0421451
Projected Start Date of Treatment
Beskrivning

ProjectedStartDateofTreatment

Datatyp

date

Alias
UMLS CUI-1
C3173309
Patient Gender
Beskrivning

Patient Gender

Datatyp

text

Alias
UMLS CUI-1
C0079399
Patient's Ethnicity
Beskrivning

Patient's Ethnicity

Datatyp

text

Alias
UMLS CUI-1
C0015031
Patient's Race
Beskrivning

Patient's Race

Datatyp

text

Alias
UMLS CUI-1
C0034510
Prior adjuvant tamoxifen therapy
Beskrivning

Prior adjuvant tamoxifen therapy

Datatyp

boolean

Consent
Beskrivning

Consent

Alias
UMLS CUI-1
C1511481
Date Informed Consent Signed
Beskrivning

DateInformedConsentSigned

Datatyp

date

Alias
UMLS CUI-1
C2985782
My tissue may be kept for use in research to learn about, prevent, treat, or cure cancer.
Beskrivning

Mytissuemaybekeptforuseinresearchtolearnabout,prevent,treat,orcurecancer.

Datatyp

boolean

Alias
UMLS CUI-1
C0040300
UMLS CUI-2
C1516225
My tissue may be kept for research about other health problems
Beskrivning

Mytissuemaybekeptforresearchaboutotherhealthproblems

Datatyp

boolean

Alias
UMLS CUI-1
C0040300
UMLS CUI-2
C0035168
Someone from Southwest Oncology Group may contact me in the future to ask me to take part in more research
Beskrivning

SomeonefromSouthwestOncologyGroupmaycontactmeinthefuturetoaskmetotakepartinmoreresearch

Datatyp

boolean

Alias
UMLS CUI-1
C0521104
UMLS CUI-2
C2051501
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regard future research involving my participation in this study
Beskrivning

SouthwestOncologyGroupPatientResearchConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25699
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0030705
UMLS CUI-2
C1519429
UMLS CUI-3
C1511481
UMLS CUI-4
C1512698
I agree to submit blood samples for the purpose of determining how my body metabolizes the drugs, fulvestrant and anastrozole
Beskrivning

PatientBloodSpecimenAgentMetabolismConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C12434
NCI Thesaurus Property-2
C1708
NCI Thesaurus Property-3
C19157
NCI Thesaurus Property-4
C25460
NCI Thesaurus Property-5
C21198
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0521104
UMLS CUI-2
C0178913
UMLS CUI-3
C0935916
I agree to submit blood samples for the analysis of human epidermal growth factor receptor 2 (HER-2) protein to see if high levels will predict if I am less likely to respond to hormone therapy
Beskrivning

PatientBloodSpecimenEpidermalGrowthFactorReceptorConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C12434
NCI Thesaurus Property-2
C19157
NCI Thesaurus Property-3
C25460
NCI Thesaurus Property-4
C17068
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0521104
UMLS CUI-2
C0178913
UMLS CUI-3
C0034802
I agree to submit a blood specimen for genetic expression studies to study what role the protocol treatment is having on my disease
Beskrivning

PatientBloodSpecimenGeneExpressionConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C12434
NCI Thesaurus Property-2
C19157
NCI Thesaurus Property-3
C25460
NCI Thesaurus Property-4
C16608
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0521104
UMLS CUI-2
C0178913
UMLS CUI-3
C0017262
I agree to submit a tissue specimen for the analysis of estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER-2) to see if certain levels will predict if I am likely to respond to hormone therapy
Beskrivning

PatientTissueSpecimenEpidermalGrowthFactorReceptorEstrogenReceptorConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C12801
NCI Thesaurus Property-2
C19157
NCI Thesaurus Property-3
C17069
NCI Thesaurus Property-4
C25460
NCI Thesaurus Property-5
C17068
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1511481
UMLS CUI-2
C1292533
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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: Southwest Oncology Group Registration Form (S0226)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
AssignedTreatmentArm
Item
Assigned Treatment Arm
text
ActivationDate
Item
Activation Date
text
LastAmendedDate
Item
Last Amended Date
text
Patient'sName
Item
Patient's Name
text
SWOGPatientID
Item
SWOG Patient ID
text
OtherGroupPatientNumber
Item
Other Group Patient Number
text
ParticipatingGroupProtocolNumber
Item
Participating Group Protocol Number
text
Caller'sSWOGRosterID
Item
Caller's SWOG Roster ID
text
IRBApprovalDate
Item
IRB Approval Date
text
SWOGInvestigatorNumber
Item
SWOG Investigator Number
text
OtherGroupInvestigatorIdentifierNumber
Item
Other Group Investigator Number (OR)
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
OtherGroupInvestigatorIdentifierName
Item
Other Group Investigator Name
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
OtherGroupTreatingInstitutionIdentifierNumber
Item
Other Group Institution Number
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C43359 (NCI Thesaurus ObjectClass-4)
C0441833 (UMLS 2011AA ObjectClass-4)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
OtherGroupTreatingInstitutionIdentifierName
Item
Other Group Institution Name
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C43359 (NCI Thesaurus ObjectClass-4)
C0441833 (UMLS 2011AA ObjectClass-4)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C0018704 (UMLS 2011AA ValueDomain-2)
SWOGTreatingInstitutionNumber
Item
SWOG Treating Institution Number
text
DateHIPAAAuthorizationsigned
Item
Date HIPAA Authorization signed
text
Item
Method of Payment
text
CL.10
Code List
Method of Payment
CL Item
Private (Private)
CL Item
Medicare (Medicare)
CL Item
Medicare and Private (Medicare and Private)
CL Item
Medicaid (Medicaid)
CL Item
Medicaid and Medicare (Medicaid and Medicare)
CL Item
No insurance (self-pay) (No insurance (self-pay))
CL Item
No insurance (no means) (No insurance (no means))
CL Item
Other, specify at registration (Other, specify at registration)
CL Item
unknown (unknown)
CL Item
Veterans Admin (Veterans Admin)
CL Item
Military (Military)
PatientSocialSecurityNumber
Item
Patient Social Security Number
text
Patient'sZIPCode
Item
Patient's ZIP Code
text
CountryofResidence
Item
Country of Residence
text
SocialInsuranceNumber
Item
Social Insurance Number
text
PostalCode
Item
Postal Code
text
Item Group
Patient data
C2707520 (UMLS CUI-1)
Birth date
Item
Patient's Date of Birth
date
C0421451 (UMLS CUI-1)
Treatment start date
Item
Projected Start Date of Treatment
date
C3173309 (UMLS CUI-1)
Item
Patient Gender
text
C0079399 (UMLS CUI-1)
CL.9
Code List
Patient Gender
CL Item
Female (Female)
C0086287 (UMLS CUI-1)
CL Item
Male (Male)
C0086582 (UMLS CUI-1)
Item
Patient's Ethnicity
text
C0015031 (UMLS CUI-1)
CL.11
Code List
Patient's Ethnicity
CL Item
Unknown (Unknown)
CL Item
No (not Spanish) (No (not Spanish))
CL Item
Yes, Mexican (Yes, Mexican)
CL Item
Yes, Puerto Rican (Yes, Puerto Rican)
CL Item
Yes, Cuban (Yes, Cuban)
CL Item
Yes, Central American (Yes, Central American)
CL Item
Yes, South American (Yes, South American)
CL Item
Yes, Other (Yes, Other)
CL Item
Yes, NOS (Yes, NOS)
Item
Patient's Race
text
C0034510 (UMLS CUI-1)
CL.12
Code List
Patient's Race
CL Item
White or Caucasian (White or Caucasian)
CL Item
Black or African American (Black or African American)
CL Item
Native Hawaiian or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)
CL Item
Asian (Asian)
CL Item
American Indian or Alaska Native (American Indian or Alaska Native)
Prior adjuvant tamoxifen therapy
Item
Prior adjuvant tamoxifen therapy
boolean
Item Group
Consent
C1511481 (UMLS CUI-1)
Informed consent date
Item
Date Informed Consent Signed
date
C2985782 (UMLS CUI-1)
Tissue for cancer research
Item
My tissue may be kept for use in research to learn about, prevent, treat, or cure cancer.
boolean
C0040300 (UMLS CUI-1)
C1516225 (UMLS CUI-2)
Tissue for research
Item
My tissue may be kept for research about other health problems
boolean
C0040300 (UMLS CUI-1)
C0035168 (UMLS CUI-2)
Permission for further contact
Item
Someone from Southwest Oncology Group may contact me in the future to ask me to take part in more research
boolean
C0521104 (UMLS CUI-1)
C2051501 (UMLS CUI-2)
Permission for further contact regarding research
Item
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regard future research involving my participation in this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI-1)
C1519429 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
C1512698 (UMLS CUI-4)
Permission for blood sample fulvestrant
Item
I agree to submit blood samples for the purpose of determining how my body metabolizes the drugs, fulvestrant and anastrozole
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C1708 (NCI Thesaurus Property-2)
C19157 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C21198 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0521104 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0935916 (UMLS CUI-3)
Permission blood sample HER-2
Item
I agree to submit blood samples for the analysis of human epidermal growth factor receptor 2 (HER-2) protein to see if high levels will predict if I am less likely to respond to hormone therapy
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C17068 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0521104 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0034802 (UMLS CUI-3)
Permission blood sample gene expression
Item
I agree to submit a blood specimen for genetic expression studies to study what role the protocol treatment is having on my disease
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C16608 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0521104 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0017262 (UMLS CUI-3)
consent tissue specimen
Item
I agree to submit a tissue specimen for the analysis of estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER-2) to see if certain levels will predict if I am likely to respond to hormone therapy
boolean
C16960 (NCI Thesaurus ObjectClass)
C12801 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C17069 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C17068 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI-1)
C1292533 (UMLS CUI-2)
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