ID

42870

Beskrivning

E5103 Registration Worksheet (step 2) Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C815F91-A867-3175-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C815F91-A867-3175-E044-0003BA3F9857

Nyckelord

Klinische Studie [Dokumenttyp]

D004608

D001943

Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00433511 Eligibility - E5103 Registration Worksheet (step 2) - 2746746v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: E5103 Registration Worksheet (step 2)
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Eligibility

Item Group

Eligibility

Patient Initials First

Item

First initial

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

Patient Initials Last

Item

Last initial

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

EligibilityDeterminationChecklistCompleteEligibilityInd-2

Item

Has the eligibility checklist been completed

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)
C49073 (NCI Thesaurus Property-2)
C1707357 (UMLS 2011AA Property-2)

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)

ProtocolTreatmentBevacizumabProtocolTreatmentArmAssignmentInd-2

Item

Did the patient receive treatment Arm C on step 1 of treatment?

boolean

C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C15538 (NCI Thesaurus Property-2)
C1522541 (UMLS 2011AA Property-2)
C25426 (NCI Thesaurus Property-3)
C1516050 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Patient Weight

Item

Patient Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

PersonWeightValue

Item

Patient weight (lb)

float

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
C25208 (NCI Thesaurus ValueDomain)
C0043100 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

AgentDeliveryInd-3

Item

Do you wish to use an express carrier to ship the drugs (at your expense)?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus Property)

CL.4

Code List

Do you wish to use an express carrier to ship the drugs (at your expense)?

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C17998 (NCI Thesaurus-3)
C0439673 (UMLS 2011AA-4)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

DeliveryCompanyIdentifierName

Item

Name of express carrier

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C54131 (NCI Thesaurus ObjectClass)
C0683757 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus ObjectClass-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CL.5

Code List

Name of express carrier

CL Item

Airborne Express (Airborne Express)

CL Item

Dhl (DHL)

CL Item

Federal Express (Federal Express)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Ups (UPS)

DeliveryCompanyPaymentIdentifierNumber

Item

Express account number

text

C54131 (NCI Thesaurus ObjectClass)
C0683757 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25371 (NCI Thesaurus Property-2)
C0680264 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

DeliveryCompanyContactPersonName

Item

Contact person for drug ordering

text

C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C54131 (NCI Thesaurus ObjectClass)
C0683757 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus ObjectClass-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

DeliveryCompanyContactPersonTelephoneNumber

Item

Phone

text

C54131 (NCI Thesaurus ObjectClass)
C0683757 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus ObjectClass-2)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25395 (NCI Thesaurus ValueDomain-2)
C0039457 (UMLS 2011AA ValueDomain-2)

DeliveryCompanyContactPersonE-mailAddress

Item

E-mail address

text

C54131 (NCI Thesaurus ObjectClass)
C0683757 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus ObjectClass-2)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C42775 (NCI Thesaurus Property-2)
C1705961 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

PersonEasternCooperativeOncologyGroupSequenceDeidentificationNumber

Item

Patient's ECOG sequence number

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25673 (NCI Thesaurus Property-2)
C1519249 (UMLS 2011AA Property-2)
C45970 (NCI Thesaurus Property-3)
C1707660 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Patient Demographics / Pre-Treatment Characteristics

Item Group

Patient Demographics / Pre-treatment Characteristics

PatientSexCode

Item

Patient's Sex

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28421 (NCI Thesaurus Property)
C1522384 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ValueDomain-2)
C0030705 (UMLS 2011AA ValueDomain-2)
C28421 (NCI Thesaurus ValueDomain-3)
C1522384 (UMLS 2011AA ValueDomain-3)

CL.6

Code List

Patient's Sex

CL Item

Female (F)

C16576 (NCI Thesaurus)
C0086287 (UMLS 2011AA)

CL Item

Male (M)

C20197 (NCI Thesaurus)
C0086582 (UMLS 2011AA)

Birth Date

Item

Birthdate (mm/yy)

date

C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25155 (NCI Thesaurus Property)

Racial Group

Item

Patient Race (check all that applyU.S. and Canada only)

text

C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)

CL.7

Code List

Patient Race (check all that applyU.S. and Canada only)

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)

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 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

Not Provided Or Available (Not Reported)

C43234 (NCI Thesaurus)
C1706613 (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

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

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

AddressPostalCodeIdentifier

Item

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)

Ethnic Group

Item

Patient Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)

CL.8

Code List

Patient Ethnicity

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

Not Provided Or Available (Not reported)

C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

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)

Social Security Number

Item

Patient Social Security Number

text

C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)

PatientInternationalPaymentType

Item

Method of payment (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
C25541 (NCI Thesaurus Property-2)
C1512888 (UMLS 2011AA Property-2)

CL.9

Code List

Method of payment (check 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 Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))

CL Item

Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))

CL Item

National Health Service (National Health Service)

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)

AttendingPhysicianIdentifierIndividualsName

Item

Attending Physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL317115 (NCI Metathesaurus ObjectClass)

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)

Protocol Registrar

Item

Registrar

text

C25191 (NCI Thesaurus ValueDomain)
C1507394 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C0557514 (UMLS CUI-2)
C25357 (NCI Thesaurus ObjectClass)

Country of current residence

Item

Country of Residence

text

C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

TreatingPhysicianSignatureText

Item

Signature of treating physician (I have reviewed the above data and agree the date are accurate and correct)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C51883 (NCI Thesaurus ObjectClass)
C1710470 (UMLS 2011AA ObjectClass)

TreatingPhysicianSignatureDate

Item

Date (Note: Date must be on or before date of registration)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C51883 (NCI Thesaurus ObjectClass)
C1710470 (UMLS 2011AA ObjectClass)

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Breast Cancer NCT00433511 Eligibility - E5103 Registration Worksheet (step 2) - 2746746v1.0

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