ID

43242

Beskrivning

Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=70E10B08-8A7D-A35C-E040-BB89AD432A74

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=70E10B08-8A7D-A35C-E040-BB89AD432A74

Nyckelord

D015179

Klinische Studie [Dokumenttyp]

Registration

Uppladdad den

20 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Pre-Randomization Colon Cancer Stage III N0147 NCT00079274

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: N0147: NCI Cooperative Group Pre-Randomization Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header module

Item Group

Header module

Protocol ID Coordinating Group

Item

Coordinating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Coordinating Group Code

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Protocol Title

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)

Patient Study ID

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Medical Record Number

Item

Patient Medical Record Number

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

ParticipatingGroupIdentifierCode

Item

Participating Group Code (Cooperative Group where credit will be applied)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Institution Name

Item

Institution Name (treating locatin/performance site)

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

NationalCancerInstituteInstituteCode

Item

Institution Code (CTEP Assigned number)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

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)

Visit

Item Group

Visit

Clinical Trial Period

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Reporting Period

CL Item

Pre-therapy (Pre-treatment)

C54734 (NCI Thesaurus)
C1882440 (UMLS 2011AA)

Protocol Administration

Item Group

Protocol Administration

IRB Approval Date

Item

IRB Approval Date

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

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)

PriorRandomizationDate

Item

Date of prerandomization

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus ObjectClass)
C0034656 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

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)

ResponsiblePersonE-mailAddressText

Item

Person Completing Form, E-mail

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)

Patient Demographics/Pre-Treatment Characteristics

Item Group

Patient Demographics/pre-treatment Characteristics

Patient Initials

Item

Patient Initials

text

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

PersonBirthDate

Item

Patient Birth Date

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)

Gender

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)

CL.2

Code List

Patient Gender

CL Item

Female Gender (FEMALE)

C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)

CL Item

Male Gender (MALE)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

Racial Group

Item

Patient Race

text

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

CL.3

Code List

Patient Race

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

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)

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)

Ethnic Group

Item

Patient Ethnicity

text

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

CL.4

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)

PersonAddressPostalCode

Item

Patient Zip Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

PersonAddressCountryName

Item

Country of Residence

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)

PatientPaymentType

Item

Method of Payment

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.5

Code List

Method of Payment

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

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)

Geriatric

Item

Is patient age 70 and over

boolean

C38148 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C52660 (NCI Thesaurus Property)
C1704440 (UMLS CUI [1])

KRAS Results Contact

Item Group

Kras Results Contact

ContactPersonLastIdentifierName

Item

Last Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

ContactPersonFirstIdentifierName

Item

First Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

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)

ContactPersonE-mailText

Item

E-mail

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25170 (NCI Thesaurus Property)
C0013849 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)

KRAS Results Contact (alternate)

Item Group

Kras Results Contact

Eligibility Check

Item Group

Header

ColonHistologicallyDocumentedInd-2

Item

Histologically documented adenocarcinoma of the colon

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12382 (NCI Thesaurus ObjectClass)
C0009368 (UMLS 2011AA ObjectClass)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)

LymphNodePathologicConfirmedInd-2

Item

At least one pathologically confirmed positive lymph node identified

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

LymphNodeResidualInvolvedInd-2

Item

There must be no evidence of residual involved lymph node disease

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Item

ECOG performance status (PS) 0, 1, or 2

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)

Age

Item

18 Years and older

boolean

C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])

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])

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Item

Must be willing to provide blood and tissue samples for eligibility and research purposes, as described in Sections 14.0 and 17.0

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C25340 (NCI Thesaurus Property-4)
C0457083 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PathologySpecimenCentralReviewerSubmissionInd-2

Item

Tumor tissue will be made available to NCCTG for centralized KRAS testing prior to registration/randomization

boolean

C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
C51807 (NCI Thesaurus Property-2)
C1707338 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CentralPathologyReviewPriorRandomizationRequirementInd-2

Item

A pre-randomization pathology review is required. The site has reviewed and understands the process listed in Section 17.0 and must account for sufficient time to complete pre-randomization and registration/randomization steps.

boolean

C71684 (NCI Thesaurus ObjectClass)
C2347585 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25652 (NCI Thesaurus Property-3)
C1514873 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Contraindications

Item Group

Contraindications

PatientPhysicalExaminationPregnancyBreastFeedingContraindicatedInd-2

Item

Any of the following: Pregnant women, Nursing women, Men or women of childbearing potential who are unwilling to employ adequate contraception

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus ObjectClass-2)
C0031809 (UMLS 2011AA ObjectClass-2)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property-2)
C1444657 (UMLS 2011AA Property-2)
C25596 (NCI Thesaurus Property-3)
C0006147 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ResidualLymphNodeInvolvedPresentInd-2

Item

Evidence of residual involved lymph node diseases

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

MetastasisRandomizationInd-2

Item

Distant metastatic disease at the time of registration/randomization

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)

PriorCancerTreatmentInd-2

Item

Prior chemotherapy or radiation therapy for treatment of this malignancy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)

PriorEpidermalGrowthFactorReceptorTherapyPerformedInd-3

Item

Prior therapy with agent(s) directed against EGFR

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C17068 (NCI Thesaurus ObjectClass-3)
C0034802 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

AntibodyAllergicReactionInd-2

Item

Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25637 (NCI Thesaurus Property)
C0443286 (UMLS 2011AA Property)
C16295 (NCI Thesaurus ObjectClass)
C0003241 (UMLS 2011AA ObjectClass)

PreviousCancerIdentifiedInd-2

Item

Previous or concurrent malignancy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)

PatientMedicalContraindicatedInd-2

Item

Any of the following conditions (Uncontrolled high blood pressure, Unstable angina, Symptomatic congestive heart failure, Myocardial infarction less than 6 months prior to randomization, NYHA class III or IV, Symp pulmonary fibrosis or intersitial pneumonitis, Active uncontrolled bacterial, viral, Systemic fungal infection)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37933 (NCI Thesaurus Property)
C1444657 (UMLS 2011AA Property)

OtherPatientMedicalContraindicatedInd-2

Item

Other medical condition which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

boolean

PeripheralNeuropathyPresentInd-2

Item

Clinically significant peripheral neuropathy at the time of randomization

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C4731 (NCI Thesaurus ObjectClass)
C0031117 (UMLS 2011AA ObjectClass)
C25233 (NCI Thesaurus ObjectClass-2)
C0205100 (UMLS 2011AA ObjectClass-2)

CancerTreatmentConcurrentAdministeredInd-2

Item

Concurrent use of other anti-cancer therapy including chemotherapy agents, target agents, or biological agents

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C16212 (NCI Thesaurus ObjectClass)
C0920425 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

PlatinumCompoundHypersensitivityIdentifiedInd-2

Item

Known allergy to other platinum compounds

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3114 (NCI Thesaurus ObjectClass)
C0020517 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
C0206135 (NCI Metathesaurus ObjectClass)

GastrointestinalHemorrhageInadequateTreatmentPersonalMedicalHistoryInd-2

Item

History of gastrointestinal bleeding that has not been appropriately addressed based on assessment of the enrolling physician

boolean

C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus ObjectClass-2)
C0019080 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property)
CL124436 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Pre-Randomization Check

Item Group

Pre-randomization Check

ImmunohistochemistryReportInd-2

Item

Request Letter for Immunohistochemistry Test Results has been given to the patient

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C16722 (NCI Thesaurus ObjectClass)

InformedConsentFormSignedInd-2

Item

Consent form signed and dated

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

PatientHealthRecordIndicator

Item

Authorization for use and disclosure of protected health information signed and dated

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25178 (NCI Thesaurus Property)
C0018684 (UMLS 2011AA Property)

CL.30

Code List

Authorization for use and disclosure of protected health information signed and dated

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C48660 (NCI Thesaurus-3)
C1272460 (UMLS 2011AA-4)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientSignedDischargeMedicalRecordDate

Item

Date of authorization

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)

DataUnknownText

Item

Not Applicable

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

PatientCorrelativeStudySpecimenConsentInd-3

Item

Patient has agreed by signature of consent form to allow tissue and blood samples to be used for correlative science studies associated with this study

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientRegisteredInd-2

Item

Patient will automatically be registered to the translational research component of this study at the time of pre-randomization.

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Item

Blood draw kit availability checked

boolean

C15207 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25429 (NCI Thesaurus Property-4)
C0470187 (UMLS 2011AA Property-4)
C49073 (NCI Thesaurus Property-5)
C1707357 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

The following will also be recorded:

Item Group

The Following Will Also Be Recorded:

PersonColorectalSpecimenResearchConsentInd-2

Item

Patient has given permission to store blood and paraffin-embedded tissue for future research of colorectal cancer

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C13363 (NCI Thesaurus Property-2)
C0555952 (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)

PersonSpecimenOtherDiseaseorDisorderFutureResearchInd-2

Item

Patient has given permission to store blood and paraffin-embedded tissue for future research to prevent, or treat other health problems

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C67527 (NCI Thesaurus Property-3)
C0016884 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-4)
C0012634 (UMLS 2011AA Property-3)
C19157 (NCI Thesaurus Property-5)
C0370003 (UMLS 2011AA Property-4)
C25460 (NCI Thesaurus Property-6)
C1511481 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonSpecimenExternalInvestigatorConsentInd-2

Item

Patient has given NCCTG permission to give their blood and paraffin-embedded tissue to outside researchers

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25936 (NCI Thesaurus Property-3)
C0035173 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

The following will also be recorded:

Item Group

The Following Will Also Be Recorded:

Protocol Design

Item Group

Protocol Design

Protocol Treatment Arm

Item

Assigned Treatment

text

C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)

CL.37

Code List

Assigned Treatment

CL Item

Pre-randomization (Pre-randomization)

RegisteringPersonIdentifierSignatureName

Item

Person pre-randomizing

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)

PersonCancerTrialsSupportUnitRandomizationName

Item

CTSU Random. specialist

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C20090 (NCI Thesaurus Property-2)
C1516236 (UMLS 2011AA Property-2)

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Date of Investigator Signature

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

Tillbaka till toppen

ID

Beskrivning

Länk

Nyckelord

Versioner (6)

Uppladdad den

DOI

Licens

Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

Pre-Randomization Colon Cancer Stage III N0147 NCT00079274

No Instruction available.

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias