ID

6195

Descripción

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

Palabras clave

Versiones (3)
  1. 18/12/14 18/12/14 - Martin Dugas
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 25/7/15 25/7/15 - Martin Dugas
Subido en

18 de diciembre de 2014

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00601900 Registration - CALGB 40503 REGISTRATION WORKSHEET - 2551888v1.0

Inglés

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 formularios  
Header Module
Descripción

Header Module

Lead Institution
Descripción

Lead Institution

Tipo de datos

text

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

Combined Institution Name

Tipo de datos

text

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

Patient CALGB Identifier Number

Tipo de datos

text

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

Registered Investigator Name

Tipo de datos

text

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

Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass
C17005
NCI Thesaurus Property
C25364
Protocol Administration
Descripción

Protocol Administration

IRB Approval Date
Descripción

Protocol IRB Approved Date

Tipo de datos

date

Unidades de medida
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C16741
NCI Thesaurus Property
C25425
UMLS CUI-1
C2346846
UMLS CUI-2
C0011008
MM DD YYYY
Date Informed Consent Signed
Descripción

Informed Consent Date

Tipo de datos

date

Unidades de medida
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI-1
C2985782
MM DD YYYY
Projected Start Date of Treatment (MM DD YYYY)
Descripción

Treatment Projected Begin Date

Tipo de datos

date

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

Patient Signed Discharge Medical Record Date

Tipo de datos

date

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

InstitutionContactPersonName

Tipo de datos

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
C25461
UMLS 2011AA ObjectClass
C0337611
Phone
Descripción

ResponsiblePersonPhoneNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
Fax
Descripción

ResponsiblePersonFaxNumber

Tipo de datos

text

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

Patient Demographics/pre-treatment Characteristics

Patient Initials (Last, First Middle)
Descripción

Patient Initials

Tipo de datos

text

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

Patient Birth Date

Tipo de datos

date

Unidades de medida
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS CUI-1
C0421451
MM DD YYYY
Patient Social Security Number
Descripción

Social Security Number

Tipo de datos

text

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

Patient Medical Record Number

Tipo de datos

text

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

Gender

Tipo de datos

text

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

Race

Tipo de datos

text

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

Ethnicity

Tipo de datos

text

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

Patient Demographics/pre-treatment Characteristics2

Performance Status (ECOG/Zubrod scale)
Descripción

ECOG

Tipo de datos

text

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

Patient Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0489786
cm
Weight
Descripción

Patient Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C1305866
Kg
Body Surface Area
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m^2
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI-1
C0005902
m^2
Disease (Advanced Breast Cancer)
Descripción

DiseaseDescriptionText

Tipo de datos

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)
Descripción

DiseaseDescriptionStage

Tipo de datos

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)
Descripción

Payment method

Tipo de datos

text

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

Zip code

Tipo de datos

text

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

Country of Residence

Tipo de datos

text

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

Certification Of Eligibility And Protocol Design

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

PatientEligibilityIndicator

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Stratification Factors
Descripción

StudyStratificationText

Tipo de datos

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
Descripción

HormoneTherapyPlannedType

Tipo de datos

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)
Descripción

FirstPostDiagnosisProgressionPresentDuration

Tipo de datos

text

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

Measurable Disease

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass
C37894
Assigned Treatment Arm
Descripción

TreatmentArmNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus ObjectClass
C15368
Kit number
Descripción

BlindedProtocolAgentIdentifierNumber

Tipo de datos

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
C49068
UMLS 2011AA ObjectClass
C0150108
Initial Patient Consent For Specimen Use
Descripción

Initial Patient Consent For Specimen Use

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

SpecimenResearchConsentRelatedInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C15319
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property
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
Descripción

SpecimenRelatedGeneticResearchConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
NCI Thesaurus Property
C17938
NCI Thesaurus Property
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
Descripción

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C9305
NCI Thesaurus Property
C19157
NCI Thesaurus Property
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)
Descripción

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17649
NCI Thesaurus Property
C2991
NCI Thesaurus Property
C15206
NCI Thesaurus Property
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
Descripción

PatientContactConsentInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C67527
NCI Thesaurus Property
C25460
NCI Thesaurus Property
C16452
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0030705
UMLS CUI-2
C0016884
UMLS CUI-3
C1511481
UMLS CUI-4
C0009452
UMLS CUI-5
C1512699
Registration Information
Descripción

Registration Information

CALGB Patient ID
Descripción

Patient CALGB Identifier Number

Tipo de datos

text

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

PatientRegistrationDate

Tipo de datos

date

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

PatientParticipatingIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Registrar's Signature
Descripción

RegisteringPersonIdentifierSignatureName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25645
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C25678
UMLS 2011AA ValueDomain
C1519316
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Similar models

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header Module
Leading Medical center
Item
Lead Institution
text
C21541 (NCI Thesaurus ObjectClass)
C25552 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C1522538 (UMLS CUI-1)
C0565990 (UMLS CUI-2)
Institution name
Item
Inst/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
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)
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)
C2826892 (UMLS CUI-1)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
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)
C16741 (NCI Thesaurus Property)
C25425 (NCI Thesaurus Property)
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)
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)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
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)
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)
C0337611 (UMLS 2011AA ObjectClass)
ResponsiblePersonPhoneNumber
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA 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)
C1273518 (UMLS 2011AA ObjectClass)
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's Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
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)
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)
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)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C1305866 (UMLS CUI-1)
Body Surface Area
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)
C1562954 (UMLS CUI-1)
Item Group
Certification Of Eligibility And Protocol Design
Item
In the opinion of the investigator, is the patient eligible?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.6
Code List
In the opinion of the investigator, is the patient eligible?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C0687676 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
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)
TreatmentArmNumber
Item
Assigned Treatment Arm
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA 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)
C0150108 (UMLS 2011AA ObjectClass)
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)
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)
C17938 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
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)
C19157 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
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)
C15206 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
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)
PatientContactConsentInd-3
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)
C16452 (NCI Thesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI-1)
C0016884 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
C0009452 (UMLS CUI-4)
C1512699 (UMLS CUI-5)
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)
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)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
RegisteringPersonIdentifierSignatureName
Item
Registrar's Signature
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25645 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus ValueDomain)
C1519316 (UMLS 2011AA ValueDomain)
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