ID

9080

Beschreibung

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

Stichworte

Klinische Studie [Dokumenttyp]

Registration

Mammatumoren, Mensch

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00601900 Registration - CALGB 40503 REGISTRATION WORKSHEET - 2551888v1.0

Modell
Details

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 Formulare

StudyEvent: CALGB 40503 REGISTRATION WORKSHEET
1. 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

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

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)

Protocol Administration

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)

Patient Demographics/Pre-Treatment Characteristics1

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-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)

Gender

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)

Race

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)

Ethnicity

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)

Patient Demographics/Pre-Treatment Characteristics2

Item Group

Patient Demographics/pre-treatment Characteristics2

ECOG

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)

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)

Payment method

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)

Certification Of Eligibility and Protocol Design

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)

HormoneTherapyPlannedType

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)

FirstPostDiagnosisProgressionPresentDuration

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)

Initial Patient Consent For Specimen Use

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)

Registration Information

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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Modell Kommentare :

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Item Kommentare für :

Breast Cancer NCT00601900 Registration - CALGB 40503 REGISTRATION WORKSHEET - 2551888v1.0

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

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