ID

11806

Beschrijving

A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B0F2A23-99E0-5C6F-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B0F2A23-99E0-5C6F-E044-0003BA3F9857

Trefwoorden

Klinische Studie [Dokumenttyp]

Registration

C50.9

Geüploaded op

4 augustus 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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Registration Breast Cancer NSABP B-40 NCT00408408

model
Details

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 Formulieren

StudyEvent: NSABP Protocol B-40 - Registration Form
1. Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

NSABP REGISTRATION FORM

Item Group

NSABP REGISTRATION FORM

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)

Patient ID NSABP

Item

NSABP Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)

Birth Date

Item

Patient's Date of Birth

date

C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)

PatientPersonSocialSecurityNumber

Item

Patient Social Security Number (USA only)

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)

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)

Investigator Name

Item

Physician of Record

text

C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)

Informed Consent Date

Item

Informed Consent Date

date

C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI [1])

Person Completing Form Last Name

Item

Person Completing Form, Last Name

text

C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)

Person Completing Form First Name

Item

Person Completing Form, First Name

text

C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)

Person Completing Form Phone

Item

Person Completing Form, 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

Person Completing Form, 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)

Racial Group

Item

Race (more than one may be marked)

text

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

CL.1

Code List

Race (more than one may be marked)

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 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 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 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)

PatientPaymentType

Item

Method of Payment (mark primary method only)

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)

CL.2

Code List

Method of Payment (mark primary method only)

CL Item

Private Insurance (Private Insurance)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare and Private Insurance)

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid and Medicare)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

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

Veterans Sponsored (Veterans Sponsored)

CL Item

Self Pay (no Insurance) (Self Pay (No Insurance))

CL Item

No Means Of Payment (no Insurance) (No means of payment (no insurance))

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Ethnic Group

Item

Ethnicity

text

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

CL.3

Code List

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

Could Not Be Determined Or Unsure (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Patient Country of Residence

Item

Country of Residence (if not USA)

text

C25162 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25407 (NCI Thesaurus Property)
C1562954 (UMLS CUI [1,1])
C0421449 (UMLS CUI [1,2])

CL.4

Code List

Country of Residence (if not USA)

CL Item

Usa (US)

CL Item

Puerto Rico (PR)

C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)

CL Item

Canada (CA)

C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)

CL Item

Other (Other)

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)

PatientAddressPostalCode

Item

Patient Zip Code (USA)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

Height

Item

Height

float

C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI [1])

Weight

Item

Body weight

float

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

How did the patient answer the following questions on the consent form

Item Group

How Did The Patient Answer The Following Questions On The Consent Form

BloodSpecimenCollectedInd-3

Item

I agree to have blood samples collected three times during this study (These samples will be sent to the NSABP.)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)

PatientContactConsentInd-2

Item

My study doctor (or somone he or she shooses) may contact me in the future to ask me to take part in more research. (My study doctor or someone he or she chooses may contact me in the future to ask me to take part in more research.)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16452 (NCI Thesaurus Property-3)
C0009452 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Stratification Factors

Item Group

Stratification Factors

LymphNodeInvolvementType

Item

Lymph Node Involvement

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.7

Code List

Lymph Node Involvement

CL Item

Negative Based On Clinical Evaluation (clinically negative)

CL Item

Positive Based On Clinical Evaluation (clinically positive)

Hormone receptor status

Item

Receptor Status

text

C12971 (NCI Thesaurus ObjectClass)
C17220 (NCI Thesaurus ObjectClass-2)
C28154 (NCI Thesaurus ObjectClass-3)
C20200 (NCI Thesaurus Property)
C15220 (NCI Thesaurus Property-2)
C25508 (NCI Thesaurus Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0019929 (UMLS CUI [1])

CL.8

Code List

Receptor Status

CL Item

Er And Pgr Negative (ER and PgR negative)

CL Item

Er And/or Pgr Positive (ER and/or PgR positive)

Age

Item

Age

integer

C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])

Certification of Eligibility

Item Group

Certification of Eligibility

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)

PatientPHIConsentIndicator

Item

Has the patient authorized the release of Protected Health Information to the NSABP?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

Diagnostic Core Needle Biopsy

Item Group

Diagnostic Core Needle Biopsy

SurgicalProcedureCoreBiopsyPerformedDate

Item

Date of procedure (Date of procedure)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)

ProfessionalOrganizationSurgicalPathologyIdentifierNumber

Item

Institutional surgical pathology number (core needle biopsy)

text

C19711 (NCI Thesaurus ObjectClass)
C1522486 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25698 (NCI Thesaurus Property-2)
C18189 (NCI Thesaurus Property-3)
C0030664 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Biopsy Specimens for B-40 Correlative Studies

Item Group

Biopsy Specimens For B-40 Correlative Studies

SpecimenCollectedDate

Item

Date Specimen collected

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)

AgentIdentifierPTINumber

Item

PTI Control Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

Baseline Clinical Tumor Assessment (Palpation Only)

Item Group

Target Lesions

Assessment Date

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

TargetLesionPresentCount

Item

Number of Target Lesions

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)

Non-TargetBreastLesionPresentCount

Item

Number of Nontarget Lesions [in] Breast

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C12971 (NCI Thesaurus ObjectClass-3)
C0006141 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Non-TargetAxillaLesionPresentCount

Item

Number of Nontarget Lesions [in] Axilla

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C12674 (NCI Thesaurus ObjectClass-3)
C0004454 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LesionSiteNumber

Item

Lesion Number ([Target])

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)

LesionTargetLocationType

Item

Target Lesion Site

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)

CL.11

Code List

Target Lesion Site

CL Item

Breast (Breast)

C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)

CL Item

Axilla (Axilla)

C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)

Longest Diameter of Lesion

Item

Longest Diameter of Lesion (s)

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS CUI-1)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS CUI-2)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS CUI-3)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)

LongestLesionSumDiameterMeasurement

Item

Sum of longest diameters of all target lesions (cm)

float

C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

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Trefwoorden

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Model Commentaren :

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Item Commentaren voor :

Registration Breast Cancer NSABP B-40 NCT00408408

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

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