ID

9105

Description

Southwest Oncology Group S0812 Registration Worksheet Form (Step 1) High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE8F0868-7F44-FEC9-E040-BB89AD4357E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE8F0868-7F44-FEC9-E040-BB89AD4357E7

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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brca1 Mutation Carrier NCT01097278 Registration - Southwest Oncology Group S0812 Registration Worksheet Form (Step 1) - 3289182v1.0

English

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 forms  
Header
Description

Header

Activation Date (MM DD YYYY)
Description

ClinicalStudyProtocolAmendmentActivationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C64382
UMLS 2011AA Property
C1879547
NCI Thesaurus Property-2
C41200
UMLS 2011AA Property-2
C0680532
Last Amended Date (MM DD YYYY)
Description

DataAmendedLastDate

Data type

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
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
Swog Patient Id
Description

Swog Patient Id

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-2
C25699
UMLS 2011AA Property-2
C1519429
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
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
Demography
Description

Demography

Patient First Name
Description

First Name

Data type

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
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-2
C25569
UMLS 2011AA Property-2
C0444598
Patient Last Name
Description

Last Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301584
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
Unnamed2
Description

Unnamed2

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-2
C25699
UMLS 2011AA Property-2
C1519429
NCI Thesaurus ObjectClass
C25357
UMLS 2011AA ObjectClass
C0557514
SWOG Investigator Number
Description

SouthwestOncologyGroupInvestigatorIdentifierNumber

Data type

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
Description

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Data type

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
Unnamed5
Description

Unnamed5

Date Informed Consent Signed (MM DD YYYY)
Description

InformedConsentFormSignedDate

Data type

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)
Description

HIPAA Approval Date

Data type

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)
Description

Treatment Begin Date

Data type

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 Question
Description

Stratification Question

Baseline serum 25(OH)D level
Description

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationS0812SerumType

Data type

text

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
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C13325
UMLS 2011AA ValueDomain-2
C0229671
Baseline mammographic density
Description

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationS0812MammogramType

Data type

text

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
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C20178
UMLS 2011AA ValueDomain-2
C0024671
Designated biopsy site
Description

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationS0812Type

Data type

text

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
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C20178
UMLS 2011AA ValueDomain-2
C0024671
Unnamed4
Description

Unnamed4

My blood may be kept for use in research to learn about, prevent, treat, or cure cancer
Description

BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
My blood may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Someone may contact me in the future to ask me to allow other uses of my blood
Description

PatientFutureCommunicationBloodSpecimenConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C12434
UMLS 2011AA Property-2
C0229664
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C16452
UMLS 2011AA Property-5
C0009452
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
My tissue may be kept for use in research to learn about, prevent, treat, or cure cancer
Description

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
My tissue may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

TissueSpecimenResearchConsentUnrelatedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25328
UMLS 2011AA ValueDomain-2
C0445356
Someone may contact me in the future to ask me to allow other uses of my tissue
Description

PatientFutureCommunicationTissueSpecimenConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C12801
UMLS 2011AA Property-2
C0040300
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C16452
UMLS 2011AA Property-5
C0009452
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
My mammogram may be kept for use in research to learn about, prevent, treat, or cure cancer
Description

PatientMammogramResearchActivityConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20178
UMLS 2011AA Property
C0024671
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C15429
UMLS 2011AA Property-3
C0242481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
My mammogram may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

PatientMammogramResearchActivityOtherConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C20178
UMLS 2011AA Property-2
C0024671
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C15429
UMLS 2011AA Property-4
C0242481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Someone may contact me in the future to ask me to allow other uses of my mammogram
Description

PatientFutureCommunicationMammogramConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C20178
UMLS 2011AA Property-2
C0024671
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C16452
UMLS 2011AA Property-4
C0009452
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
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

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
Unnamed 7
Description

Unnamed 7

Has the SWOG 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

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
Auxiliary Questions
Description

Auxiliary Questions

Does the participant have a known deleterious mutation in BRCA1, BRCA2, PTEN or TP53
Description

KaryotypeDeletionMutationCellInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25215
UMLS 2011AA ObjectClass
C1261273
NCI Thesaurus Property
C12508
UMLS 2011AA Property
C0007634
NCI Thesaurus Property-2
C19296
UMLS 2011AA Property-2
C1511760
Does the participant have a history of resected DCIS or LCIS
Description

DuctalBreastCarcinomaInSituLobularBreastCarcinomaInSituExcisionPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15232
UMLS 2011AA ObjectClass
C0728940
NCI Thesaurus ObjectClass-2
C2924
UMLS 2011AA ObjectClass-2
C0007124
NCI Thesaurus ObjectClass-3
C4018
UMLS 2011AA ObjectClass-3
C0279563
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
ClinicalStudyProtocolAmendmentActivationDate
Item
Activation Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C64382 (NCI Thesaurus Property)
C1879547 (UMLS 2011AA Property)
C41200 (NCI Thesaurus Property-2)
C0680532 (UMLS 2011AA Property-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
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
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
Unnamed2
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
Unnamed5
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
Stratification Question
Item
Baseline serum 25(OH)D level
text
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)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13325 (NCI Thesaurus ValueDomain-2)
C0229671 (UMLS 2011AA ValueDomain-2)
CL.2
Code List
Baseline serum 25(OH)D level
CL Item
< 20 Ng/ml (1)
CL Item
20-32 Ng/ml (2)
Item
Baseline mammographic density
text
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)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ValueDomain-2)
C0024671 (UMLS 2011AA ValueDomain-2)
CL.3
Code List
Baseline mammographic density
CL Item
11-50% (1)
CL Item
> 50% (2)
Item
Designated biopsy site
text
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)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ValueDomain-2)
C0024671 (UMLS 2011AA ValueDomain-2)
CL.4
Code List
Designated biopsy site
CL Item
Yes (1)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (2)
BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
My blood may be kept for use in research to learn about, prevent, treat, or cure cancer
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
My blood may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientFutureCommunicationBloodSpecimenConsentInd-3
Item
Someone may contact me in the future to ask me to allow other uses of my blood
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C12434 (NCI Thesaurus Property-2)
C0229664 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16452 (NCI Thesaurus Property-5)
C0009452 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
My tissue may be kept for use in research to learn about, prevent, treat, or cure cancer
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
My tissue may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
PatientFutureCommunicationTissueSpecimenConsentInd-3
Item
Someone may contact me in the future to ask me to allow other uses of my tissue
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C12801 (NCI Thesaurus Property-2)
C0040300 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16452 (NCI Thesaurus Property-5)
C0009452 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientMammogramResearchActivityConsentInd-3
Item
My mammogram may be kept for use in research to learn about, prevent, treat, or cure cancer
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20178 (NCI Thesaurus Property)
C0024671 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C15429 (NCI Thesaurus Property-3)
C0242481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientMammogramResearchActivityOtherConsentInd-3
Item
My mammogram may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20178 (NCI Thesaurus Property-2)
C0024671 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C15429 (NCI Thesaurus Property-4)
C0242481 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientFutureCommunicationMammogramConsentInd-3
Item
Someone may contact me in the future to ask me to allow other uses of my mammogram
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C20178 (NCI Thesaurus Property-2)
C0024671 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16452 (NCI Thesaurus Property-4)
C0009452 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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
Unnamed 7
SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2
Item
Has the SWOG 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)
Item Group
Auxiliary Questions
KaryotypeDeletionMutationCellInd-2
Item
Does the participant have a known deleterious mutation in BRCA1, BRCA2, PTEN or TP53
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25215 (NCI Thesaurus ObjectClass)
C1261273 (UMLS 2011AA ObjectClass)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C19296 (NCI Thesaurus Property-2)
C1511760 (UMLS 2011AA Property-2)
DuctalBreastCarcinomaInSituLobularBreastCarcinomaInSituExcisionPersonalMedicalHistoryInd-2
Item
Does the participant have a history of resected DCIS or LCIS
boolean
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C2924 (NCI Thesaurus ObjectClass-2)
C0007124 (UMLS 2011AA ObjectClass-2)
C4018 (NCI Thesaurus ObjectClass-3)
C0279563 (UMLS 2011AA ObjectClass-3)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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