ID

43467

Description

CALGB 90802 Registration Worksheet Form Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=879626AD-DB8C-4AF2-E040-BB89AD4364E1

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=879626AD-DB8C-4AF2-E040-BB89AD4364E1

Keywords

Versions (4)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Kidney Cancer NCT01198158 Registration - CALGB 90802 Registration Worksheet Form - 3103555v1.0

English

Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors

1 forms  
Header Module
Description

Header Module

Lead Institution
Description

LeadInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass-2
C25552
UMLS 2011AA ObjectClass-2
C1522538
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
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Name
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Physician
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Principal Investigator No.
Description

NationalCancerInstitutePrincipalInvestigatorIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19202
UMLS 2011AA ObjectClass
C1513882
NCI Thesaurus ObjectClass-2
C19924
UMLS 2011AA ObjectClass-2
C1521895
Protocol Administration
Description

Protocol Administration

IRB Approval Date (MM DD YYYY)
Description

IRB Approval Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS CUI-1
C2346500
NCI Thesaurus Property
C16741
NCI Thesaurus Property-2
C25425
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
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
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
HIPAA Authorization Date (MM DD YYYY)
Description

PatientSignedDischargeMedicalRecordDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Institution contact
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

ContactPersonTelephoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Fax
Description

ContactPersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
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
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Date of Birth (MM DD YYYY)
Description

PersonBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Patient Social Security Number
Description

PatientPersonSocialSecurityNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25686
UMLS 2011AA Property
C1301821
Patient Hospital No.
Description

Medical Record Number

Data type

text

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

PersonGenderTextType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Race (Mark all that apply)
Description

RaceCategoryText

Data type

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C17049
UMLS 2011AA ObjectClass
C0034510
Ethnicity (Mark one)
Description

EthnicGroupCategoryText

Data type

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16564
UMLS 2011AA ObjectClass
C0015031
Patient Demographics/pre-treatment Characteristics2
Description

Patient Demographics/pre-treatment Characteristics2

Performance Status (ECOG/Zubrod scale)
Description

ECOG Performance Status

Data type

text

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

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Description

Body Surface Area

Data type

float

Measurement units
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Method of Payment (USA only Mark one)
Description

PersonHealthcarePayerType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C70686
UMLS 2011AA Property
C2348942
NCI Thesaurus ValueDomain-2
C70686
UMLS 2011AA ValueDomain-2
C2348942
Patient Demographics/pre-treatment Characteristics3
Description

Patient Demographics/pre-treatment Characteristics3

Disease (Renal cell carcinoma)
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 (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
Pathologic type (Clear cell component)
Description

DiseasesandDisordersPathologyDescriptionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C18189
UMLS 2011AA Property
C0030664
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Patient Zip Code
Description

AddressPostalCodeIdentifier

Data type

text

Alias
NCI Thesaurus ObjectClass
C25407
UMLS 2011AA ObjectClass
C1442065
NCI Thesaurus Property
C25621
UMLS 2011AA Property
C1514254
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
NCI Thesaurus ValueDomain-2
C25407
UMLS 2011AA ValueDomain-2
C1442065
NCI Thesaurus ValueDomain-3
C25621
UMLS 2011AA ValueDomain-3
C1514254
Country of Residence (If not USA)
Description

PersonAddressCountryName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25464
UMLS 2011AA ValueDomain
C0454664
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
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
Protocol Design
Description

Protocol Design

Stratification Factors (Number of risk factors present: The risk factors are: Karnofsky performance status <80%; Corrected serum calcium >10mg/dL; and Hb <13 for males and <11.5 for females. Mark one with an X. Zero risk factors One risk factor Two or three risk factors Total duration of prior VEGFR TKI Therapy Mark one with an X. <12 weeks of therapy >=12 weeks of therapy)
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
Assigned Treatment Arm
Description

Protocol Treatment Arm

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25704
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

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
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
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C17938
UMLS 2011AA Property-2
C0314603
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
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
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
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
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
My doctor or someone from CALGB may contact me in the future to ask me to take part in more research
Description

Permission to contact Patient

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C1522577
NCI Thesaurus Property
C67527
UMLS CUI-2
C0521104
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C16452
NCI Thesaurus ValueDomain
C38148
Calgb 580902
Description

Calgb 580902

Was the patient registered to CALGB 580902 (a companion to CALGB 90802)
Description

PatientAncillaryStudyOneEligibilityDeterminationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C66832
UMLS 2011AA Property
C0205447
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C16041
UMLS 2011AA Property-3
C1515980
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Registration Information
Description

Registration Information

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
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
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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Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
LeadInstitutionName
Item
Lead Institution
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25552 (NCI Thesaurus ObjectClass-2)
C1522538 (UMLS 2011AA ObjectClass-2)
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)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
NationalCancerInstitutePrincipalInvestigatorIdentifierNumber
Item
Principal Investigator No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass)
C1513882 (UMLS 2011AA ObjectClass)
C19924 (NCI Thesaurus ObjectClass-2)
C1521895 (UMLS 2011AA ObjectClass-2)
Item Group
Protocol Administration
IRB Approval Date
Item
IRB Approval Date (MM DD YYYY)
date
C25320 (NCI Thesaurus ObjectClass)
C2346500 (UMLS CUI-1)
C16741 (NCI Thesaurus Property)
C25425 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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)
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)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
InstitutionContactPersonName
Item
Institution contact
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)
ContactPersonTelephoneNumber
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
ContactPersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (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)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PersonBirthDate
Item
Date of Birth (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
PatientPersonSocialSecurityNumber
Item
Patient Social Security Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25686 (NCI Thesaurus Property)
C1301821 (UMLS 2011AA Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Item
Gender
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.1
Code List
Gender
CL Item
Female Gender (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
CL Item
Male Gender (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
Item
Race (Mark all that apply)
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C17049 (NCI Thesaurus ObjectClass)
C0034510 (UMLS 2011AA ObjectClass)
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 Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16564 (NCI Thesaurus ObjectClass)
C0015031 (UMLS 2011AA ObjectClass)
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)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
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 (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Item
Method of Payment (USA only Mark one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C70686 (NCI Thesaurus Property)
C2348942 (UMLS 2011AA Property)
C70686 (NCI Thesaurus ValueDomain-2)
C2348942 (UMLS 2011AA ValueDomain-2)
CL.5
Code List
Method of Payment (USA only Mark one)
CL Item
Medicaid (Medicaid)
C68633 (NCI Thesaurus)
C0025071 (UMLS 2011AA)
CL Item
Medicare And Medicaid (Medicaid and Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
C37912 (NCI Thesaurus-3)
C1515981 (UMLS 2011AA-4)
C68633 (NCI Thesaurus-5)
C0025071 (UMLS 2011AA-6)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
C37912 (NCI Thesaurus-3)
C1515981 (UMLS 2011AA-4)
C16745 (NCI Thesaurus-5)
C0021672 (UMLS 2011AA-6)
C54104 (NCI Thesaurus-7)
C0679727 (UMLS 2011AA-8)
CL Item
Military Insurance (Military Sponsored (Including CHAMPUS & TriCare))
C16745 (NCI Thesaurus)
C0021672 (UMLS 2011AA)
C68638 (NCI Thesaurus-3)
C0026126 (UMLS 2011AA-4)
CL Item
No Insurance (No Means of Payment (No Insurance))
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C16745 (NCI Thesaurus-3)
C0021672 (UMLS 2011AA-4)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
C16745 (NCI Thesaurus)
C0021672 (UMLS 2011AA)
C54104 (NCI Thesaurus-3)
C0679727 (UMLS 2011AA-4)
CL Item
Self Payment (Self-Pay (No Insurance))
C25200 (NCI Thesaurus)
C0036588 (UMLS 2011AA)
C25371 (NCI Thesaurus-3)
C0680264 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Administration Sponsor Insurance (Veterans Sponsored)
C16745 (NCI Thesaurus)
C0021672 (UMLS 2011AA)
C48355 (NCI Thesaurus-3)
C1711305 (UMLS 2011AA-4)
C17239 (NCI Thesaurus-5)
C0041735 (UMLS 2011AA-6)
Item Group
Patient Demographics/pre-treatment Characteristics3
DiseaseDescriptionText
Item
Disease (Renal cell carcinoma)
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 (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)
DiseasesandDisordersPathologyDescriptionText
Item
Pathologic type (Clear cell component)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus Property)
C0030664 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
AddressPostalCodeIdentifier
Item
Patient Zip Code
text
C25407 (NCI Thesaurus ObjectClass)
C1442065 (UMLS 2011AA ObjectClass)
C25621 (NCI Thesaurus Property)
C1514254 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus ValueDomain-2)
C1442065 (UMLS 2011AA ValueDomain-2)
C25621 (NCI Thesaurus ValueDomain-3)
C1514254 (UMLS 2011AA ValueDomain-3)
PersonAddressCountryName
Item
Country of Residence (If not USA)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
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)
Item Group
Protocol Design
StudyStratificationText
Item
Stratification Factors (Number of risk factors present: The risk factors are: Karnofsky performance status <80%; Corrected serum calcium >10mg/dL; and Hb <13 for males and <11.5 for females. Mark one with an X. Zero risk factors One risk factor Two or three risk factors Total duration of prior VEGFR TKI Therapy Mark one with an X. <12 weeks of therapy >=12 weeks of therapy)
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)
Protocol Treatment Arm
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
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
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Patient's Initial Consent given for specimen use for research on the patient's 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)
SpecimenRelatedGeneticResearchConsentInd-2
Item
Patient's initial consent given for specimen use for genetic research relating to the study treatment
boolean
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property-3)
C0314603 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Permission to contact Patient
Item
My doctor or someone from CALGB may contact me in the future to ask me to take part in more research
boolean
C16960 (NCI Thesaurus ObjectClass)
C1522577 (UMLS CUI-1)
C67527 (NCI Thesaurus Property)
C0521104 (UMLS CUI-2)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
Item Group
Calgb 580902
PatientAncillaryStudyOneEligibilityDeterminationInd-3
Item
Was the patient registered to CALGB 580902 (a companion to CALGB 90802)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C66832 (NCI Thesaurus Property)
C0205447 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C16041 (NCI Thesaurus Property-3)
C1515980 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Registration Information
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)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (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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