ID

11655

Description

Registration Breast Cancer CALGB 40503 NCT00601900 Registration Breast Cancer CALGB 40503 REGISTRATION WORKSHEET - 2551888v1.0 NCT00601900 CALGB 40503 REGISTRATION WORKSHEET Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24089B14-3CCA-485C-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24089B14-3CCA-485C-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/25/15 7/25/15 - Martin Dugas
Uploaded on

July 25, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Registration Breast Cancer CALGB 40503 NCT00601900

English

Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

1 forms  
Header Module
Description

Header Module

Lead Institution
Description

Lead Institution

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ObjectClass-2
C25552
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
UMLS CUI-1
C1522538
UMLS CUI-2
C0565990
Inst/Affiliate
Description

Combined Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
UMLS CUI-1
C0565990
CALGB Patient ID
Description

Patient CALGB Identifier Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
UMLS CUI-1
C1549740
UMLS CUI-2
C1516238
Physician of Record
Description

Registered Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
UMLS CUI-1
C2826892
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Protocol Administration
Description

Protocol Administration

IRB Approval Date
Description

Protocol IRB Approved Date

Data type

date

Measurement units
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C16741
NCI Thesaurus Property-2
C25425
UMLS CUI-1
C2346846
UMLS CUI-2
C0011008
MM DD YYYY
Date Informed Consent Signed
Description

Informed Consent Date

Data type

date

Measurement units
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI-1
C2985782
MM DD YYYY
Projected Start Date of Treatment (MM DD YYYY)
Description

Treatment Projected Begin Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-1
C0439659
UMLS CUI-2
C2745955
UMLS CUI-3
C0011008
UMLS CUI-4
C0439659
HIPAA Authorization Date (MM DD YYYY)
Description

Patient Signed Discharge Medical Record Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0030705
UMLS CUI-2
C0025102
UMLS CUI-3
C0011008
Contact Person at Institution
Description

InstitutionContactPersonName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Fax
Description

ResponsiblePersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Patient Demographics/pre-treatment Characteristics
Description

Patient Demographics/pre-treatment Characteristics

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
UMLS CUI-1
C2986440
Patient Date of Birth
Description

Patient Birth Date

Data type

date

Measurement units
  • MM.DD.YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
UMLS CUI-1
C0421451
MM.DD.YYYY
Patient Social Security Number
Description

Social Security Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25686
UMLS CUI-1
C1301821
Patient Hospital No.
Description

Patient Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
UMLS CUI-1
C1301894
Gender
Description

Gender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
UMLS CUI-1
C0079399
Race (Mark all that apply)
Description

Race

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
UMLS CUI-1
C0034510
Ethnicity (Mark one)
Description

Ethnicity

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
UMLS CUI-1
C0015031
Patient Demographics/pre-treatment Characteristics2
Description

Patient Demographics/pre-treatment Characteristics2

Performance Status (ECOG/Zubrod scale)
Description

ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
UMLS CUI-1
C1520224
Height
Description

Patient Height

Data type

integer

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0489786
cm
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C0005910
kg
Body surface area
Description

Body surface area

Data type

float

Measurement units
  • m²
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI-1
C0005902
m²
Disease (Advanced Breast Cancer)
Description

DiseaseDescriptionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Stage (IIIB IV)
Description

DiseaseDescriptionStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Method of Payment (Adminstration USA only Mark one)
Description

Payment method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25371
UMLS CUI-1
C0680264
Patient Zip Code
Description

Zip code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25407
UMLS CUI-1
C1521842
Country of Residence (if not USA)
Description

Country of Residence

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C25464
NCI Thesaurus Property
C25407
NCI Thesaurus ValueDomain-2
C42614
UMLS CUI-1
C1562954
Certification Of Eligibility And Protocol Design
Description

Certification Of Eligibility And Protocol Design

In the opinion of the investigator, is the patient eligible?
Description

Eligibility for trial

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
Stratification Factors
Description

StudyStratificationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C25689
UMLS 2011AA Property
C1514983
Planned endocrine therapy
Description

HormoneTherapyPlannedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Disease Free Interval (months from initial diagnosis to first progression)
Description

FirstPostDiagnosisProgressionPresentDuration

Data type

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C38008
UMLS 2011AA ObjectClass
C0687676
NCI Thesaurus ObjectClass-3
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus ObjectClass-4
C15220
UMLS 2011AA ObjectClass-3
C0011900
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
Is measurable disease present?
Description

Measurable Disease

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C37894
Assigned Treatment Arm
Description

Protocol Treatment Arm

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus ObjectClass
C15368
Kit number
Description

BlindedProtocolAgentIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus ObjectClass-2
C49068
UMLS 2011AA ObjectClass-2
C0150108
Initial Patient Consent For Specimen Use
Description

Initial Patient Consent For Specimen Use

Patient's Initial Consent given for specimen use for research on the patient's cancer?
Description

SpecimenResearchConsentRelatedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C15319
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property-2
C25460
UMLS CUI-1
C1512699
UMLS CUI-2
C0370003
UMLS CUI-3
C1511481
Patient's initial consent given for specimen use for genetic research relating to the study treatment
Description

SpecimenRelatedGeneticResearchConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
NCI Thesaurus Property-3
C17938
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0370003
UMLS CUI-2
C0439849
UMLS CUI-3
C0314603
UMLS CUI-4
C1511481
UMLS CUI-5
C1512698
Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C9305
NCI Thesaurus Property-3
C19157
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0027361
UMLS CUI-2
C0006826
UMLS CUI-3
C0370003
UMLS CUI-4
C1511481
UMLS CUI-5
C1512698
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C2991
NCI Thesaurus Property-3
C15206
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0030705
UMLS CUI-2
C0205394
UMLS CUI-3
C0012634
UMLS CUI-4
C0008972
UMLS CUI-5
C1511481
UMLS CUI-6
C1512698
Patient's initial consent given for further contact to participate in research on future studies
Description

PatientContactConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C67527
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C16452
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
UMLS CUI-2
C0521104
Registration Information
Description

Registration Information

CALGB Patient ID
Description

Patient CALGB Identifier Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
UMLS CUI-1
C1549740
UMLS CUI-2
C1516238
Registration Date (MM DD YYYY)
Description

PatientRegistrationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Registrar's Signature
Description

RegisteringPersonIdentifierSignatureName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25645
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain-2
C25678
UMLS 2011AA ValueDomain-2
C1519316
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Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Leading Medical center
Item
Lead Institution
text
C21541 (NCI Thesaurus ObjectClass)
C25552 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C1522538 (UMLS CUI-1)
C0565990 (UMLS CUI-2)
Institution name
Item
Inst/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C0565990 (UMLS CUI-1)
Patient ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1516238 (UMLS CUI-2)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
C2826892 (UMLS CUI-1)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Item Group
Protocol Administration
Protocol approval date
Item
IRB Approval Date
date
C25164 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C16741 (NCI Thesaurus Property)
C25425 (NCI Thesaurus Property-2)
C2346846 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Informed Consent Date
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI-1)
Treatment Projected 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)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS CUI-1)
C2745955 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0439659 (UMLS CUI-4)
Patient Signed Discharge Medical Record Date
Item
HIPAA Authorization Date (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI-1)
C0025102 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
InstitutionContactPersonName
Item
Contact Person at Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
ResponsiblePersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
Item Group
Patient Demographics/pre-treatment Characteristics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
Patient Birth Date
Item
Patient Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1)
Social Security Number
Item
Patient Social Security Number
text
C25337 (NCI Thesaurus ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)
C1301821 (UMLS CUI-1)
Patient Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
C1301894 (UMLS CUI-1)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS CUI-1)
CL.1
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item
Race (Mark all that apply)
text
C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS CUI-1)
CL.2
Code List
Race (Mark all that apply)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
Item
Ethnicity (Mark one)
text
C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS CUI-1)
CL.3
Code List
Ethnicity (Mark one)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Patient Demographics/pre-treatment Characteristics2
Item
Performance Status (ECOG/Zubrod scale)
text
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI-1)
CL.4
Code List
Performance Status (ECOG/Zubrod scale)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
Patient Height
Item
Height
integer
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS CUI-1)
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
BSA
Item
Body surface area
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
DiseaseDescriptionText
Item
Disease (Advanced Breast Cancer)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
DiseaseDescriptionStage
Item
Stage (IIIB IV)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Method of Payment (Adminstration USA only Mark one)
text
C25284 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS CUI-1)
CL.5
Code List
Method of Payment (Adminstration USA only Mark one)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Sponsored (Veterans Sponsored)
Zip code
Item
Patient Zip Code
text
C25162 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25407 (NCI Thesaurus Property)
C1521842 (UMLS CUI-1)
Country of Residence
Item
Country of Residence (if not USA)
text
C16960 (NCI Thesaurus ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
C1562954 (UMLS CUI-1)
Item Group
Certification Of Eligibility And Protocol Design
Eligibility for trial
Item
In the opinion of the investigator, is the patient eligible?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
StudyStratificationText
Item
Stratification Factors
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
Item
Planned endocrine therapy
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
CL.7
Code List
Planned endocrine therapy
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
Item
Disease Free Interval (months from initial diagnosis to first progression)
text
C25331 (NCI Thesaurus ObjectClass)
C38008 (NCI Thesaurus ObjectClass-2)
C0687676 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-3)
C1279901 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus ObjectClass-4)
C0011900 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
CL.8
Code List
Disease Free Interval (months from initial diagnosis to first progression)
CL Item
<= 24 Months (<= 24 months)
CL Item
> 24 Months (> 24 months)
Measurable Disease
Item
Is measurable disease present?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
Protocol Treatment Arm
Item
Assigned Treatment Arm
text
C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
BlindedProtocolAgentIdentifierNumber
Item
Kit number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C49068 (NCI Thesaurus ObjectClass-2)
C0150108 (UMLS 2011AA ObjectClass-2)
Item Group
Initial Patient Consent For Specimen Use
SpecimenResearchConsentRelatedInd-3
Item
Patient's Initial Consent given for specimen use for research on the patient's cancer?
boolean
C38148 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus Property)
C19157 (NCI Thesaurus ObjectClass)
C25460 (NCI Thesaurus Property-2)
C1512699 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
SpecimenRelatedGeneticResearchConsentInd-2
Item
Patient's initial consent given for specimen use for genetic research relating to the study treatment
boolean
C19157 (NCI Thesaurus ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C17938 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0370003 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
C1511481 (UMLS CUI-4)
C1512698 (UMLS CUI-5)
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
Item
Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
boolean
C25190 (NCI Thesaurus ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C19157 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0027361 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
C0370003 (UMLS CUI-3)
C1511481 (UMLS CUI-4)
C1512698 (UMLS CUI-5)
PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2
Item
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C16960 (NCI Thesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property-2)
C15206 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0008972 (UMLS CUI-4)
C1511481 (UMLS CUI-5)
C1512698 (UMLS CUI-6)
Permission to contact Patient
Item
Patient's initial consent given for further contact to participate in research on future studies
boolean
C16960 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C0521104 (UMLS CUI-2)
Item Group
Registration Information
Patient ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1516238 (UMLS CUI-2)
PatientRegistrationDate
Item
Registration Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
RegisteringPersonIdentifierSignatureName
Item
Registrar's Signature
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25645 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus ValueDomain-2)
C1519316 (UMLS 2011AA ValueDomain-2)
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