ID

43383

Descrição

NSABP PROTOCOL C-08: REGISTRATION FORM Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer NCT00096278 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Palavras-chave

  1. 27/08/2012 27/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 22/03/2015 22/03/2015 - Martin Dugas
  4. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Colon cancer (NSABP C-08 NCT00096278)

Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

Header
Descrição

Header

NSABP Patient ID
Descrição

Patient ID NSABP

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Patient Medical Record Number
Descrição

Medical Record Number

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution Name
Descrição

Institution Name

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution Number
Descrição

Institution Number

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Affiliate Name
Descrição

Affiliate Name

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician of Record (physician to whom subsequent vials will be sent must have a valid FDA number)
Descrição

Investigator Name

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Date Informed Consent Signed (Month Day Year)
Descrição

InformedConsentFormSignedDate

Tipo de dados

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
Person Completing Form Last Name
Descrição

Person Completing Form Last Name

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form First Name
Descrição

Person Completing Form First Name

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Person Completing Form Phone
Descrição

Person Completing Form Phone

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Person Completing Form Fax
Descrição

ResponsiblePersonFaxNumber

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Patient Initials (Last, First Middle)
Descrição

Patient Initials

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Social Security Number (USA only)
Descrição

PatientSocialSecurityNumber

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Race (more than one may be marked)
Descrição

Racial Group

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Method of Payment (mark primary method only)
Descrição

PatientPaymentType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Ethnicity
Descrição

PatientEthnicityCategory

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C29933
Country of Residence (if not USA)
Descrição

PatientAddressCountryCode

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Patient's Zip Code (USA)
Descrição

PatientAddressPostalCode

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Performance Status
Descrição

PerformanceStatusScale

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Patient characteristics
Descrição

Patient characteristics

Alias
UMLS CUI-1
C0815172
Patient Height (cm)
Descrição

Patient Height

Tipo de dados

float

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Patient Weight (kg)
Descrição

Patient Weight

Tipo de dados

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Patient Gender
Descrição

Gender

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0079399
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
Patient's Date of Birth (Month Day Year)
Descrição

Birth Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Date of Surgery (Month Day Year)
Descrição

Surgery Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1628561
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus Property
C25275
Date of Proposed Treatment (Month Day Year)
Descrição

TreatmentPlannedDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Lymph Nodes Number Examined
Descrição

LymphNodeExaminedCount

Tipo de dados

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Lymph Nodes Number Positive
Descrição

LymphNodePositiveCount

Tipo de dados

float

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Blood Pressure Systolic (Report the Most Recent Blood Pressure)
Descrição

BloodPressure,Systolic

Tipo de dados

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Blood Pressure Diastolic (Report the Most Recent Blood Pressure)
Descrição

Bloodpressure,Diastolic

Tipo de dados

text

Alias
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C25299
UMLS 2011AA ObjectClass
C0428883
Menopausal status (Females only)
Descrição

PatientMenopauseStatus

Tipo de dados

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C3231
NCI Thesaurus ValueDomain
C25688
UMLS CUI-1
C0455962
Serum Creatinine Patient Value
Descrição

PatientCreatinineSerumValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C13325
NCI Thesaurus Property-2
C399
UMLS CUI-1
C0201976
mg/dL
Serum Creatinine Upper Limit of Lab Normal (mg/dL)
Descrição

Creatinine, serum ULN

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
mg/dL
Urine Protein/Creatinine Ratio
Descrição

UrinaryCreatinineProteinAssessmentValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C25711
UMLS 2011AA ObjectClass
C1524119
NCI Thesaurus ObjectClass-2
C17021
UMLS 2011AA ObjectClass-2
C0033684
NCI Metathesaurus ObjectClass
C0010294
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date of Measurement (month day year)
Descrição

Laboratory Procedure Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Protein from 24 hour Urine Collection (g)
Descrição

UrinaryProteinCollectionValue

Tipo de dados

float

Unidades de medida
  • g/24 hours
Alias
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ObjectClass
C17021
UMLS 2011AA ObjectClass
C0033684
g/24 hours
Your blood and tissue samples may be kept by the NSABP for use in this study and future research to learn about, prevent, detect, or treat cancer.
Descrição

Your blood and tissue samples may be kept by the NSABP for use in this study and future research to learn about, prevent, detect, or treat cancer.

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C9305
NCI Thesaurus Property-2
C25460
UMLS CUI-1
C0040288
UMLS CUI-2
C1516225
Your blood and tissue samples may be used for research about other health problems (for example: causes of heart disease, osteoporosis, diabetes).
Descrição

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C2991
NCI Thesaurus Property-3
C15206
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0040288
UMLS CUI-2
C0242481
Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research.
Descrição

PatientContactConsentInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C67527
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C16452
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1511481
UMLS CUI-2
C2051501
Your blood samples may be collected and sent to Genetech, Inc. for bevacizumab antibody testing.
Descrição

PersonBloodCollectionLabsInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C12434
NCI Thesaurus Property-2
C25453
C-08 Eligibility Checklist
Descrição

C-08 Eligibility Checklist

Alias
UMLS CUI-1
C0013893
Does the patient have psychiatric or addictive disorders that would preclude the patient from meeting the study requirements?
Descrição

PatientStudyRequirementInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C38015
Has the patient authorized the release of Protected Health Information to the NSABP?
Descrição

PatientPHIConsentIndicator

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Has the patient consented to participate in this study and signed and dated an approved consent form?
Descrição

Hasthepatientconsentedtoparticipateinthisstudyandsignedanddatedanapprovedconsentform?

Tipo de dados

boolean

Alias
UMLS CUI-1
C0021430
Does the patient have a colon tumor that is other than adenocarcinoma?
Descrição

OtherPatientColonTumorInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
CL053268
Were there any isolated, distant, or non-contiguous intra-abdominal metastases (other than regional lymph nodes)?
Descrição

AbdominalCavityMetastasisPresentInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C12664
NCI Thesaurus Property-2
C19151
UMLS CUI-1
C0854198
Did the patient have an en bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy, i.e., curative resection?
Descrição

EnBlocResectionTumorCompleteInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C15232
UMLS 2011AA ObjectClass
C0728940
Has the patient received any systemic therapy or surgery (other than a decompressive colostomy or en bloc resection of tumor) for the current colon cancer?
Descrição

SystemicTherapyColorectalCarcinomaPerformedInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C2955
UMLS 2011AA Property-2
C0009402
Is the distal extent of the lowest lying colon tumor greater or equal to 12 cm from the anal verge?
Descrição

ColonTumorDistanceAnalVergeInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25419
UMLS 2011AA Property
C0227423
Does the patient have a histologically confirmed Stage II (T3, 4 N0 M0) or Stage III (any T N1,2 M0) tumor?
Descrição

TumorHistologicallyConfirmedInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
Is there postoperative evidence of adequate hepatic function as described in the protocol?
Descrição

LiverFunctionInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C12392
NCI Thesaurus Property
C25518
UMLS CUI-1
C0232741
Are the postoperative absolute granulocyte count and platelet count within the criteria set by the protocol?
Descrição

LaboratoryProcedurePost-OperativePlateletNormalResultInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C14165
UMLS 2011AA Property
C0205307
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C12520
UMLS 2011AA Property-3
C0005821
NCI Thesaurus Property-4
C25623
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient's PT (INR) within the criteria set by the protocol?
Descrição

PatientCoagulationBloodInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
Does the patient have significant peripheral neuropathy defined in the NCI CTCAE v3.0 as a grade 2 or greater neurosensory or neuromotor toxicity?
Descrição

NeuropathyAdverseEventToxicityInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C27990
UMLS 2011AA Property
C0600688
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?
Descrição

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C15329
NCI Thesaurus Property-2
C3671
NCI Thesaurus Property-3
C25171
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0679637
Does the patient have uncontrolled hypertension?
Descrição

UncontrolledHypertensionPresentInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C3117
NCI Thesaurus ObjectClass-2
C48932
UMLS CUI-1
C1868885
Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated?
Descrição

PatientNeoplasmPersonalMedicalHistoryInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C3262
NCI Thesaurus Property-2
C18772
UMLS CUI-1
C0455471
Does the patient have Class III or Class IV cardiac disease or symptomatic arrhythmia
Descrição

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
NCI Thesaurus Property-2
C7922
UMLS CUI-1
C0278962
Does the patient have a history of myocardial infarction or unstable angina within the past 12 months
Descrição

Does the patient have a history of myocardial infarction or unstable angina within the past 12 months

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C27996
NCI Metathesaurus ObjectClass
C0030705
NCI Thesaurus Property
C25627
NCI Thesaurus Property-2
C29848
NCI Thesaurus Property-3
C18772
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1956346
Does the patient have a prior history of TIA or CVA
Descrição

PatientTransientIschemicAttackCerebrovascularAccidentPersonalMedicalHistoryInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C29867
NCI Thesaurus Property
C50781
NCI Thesaurus Property-2
C3390
NCI Thesaurus Property-3
C18772
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0455536
Does the patient have a history of symptomatic peripheral vascular disease
Descrição

HistoryofPeripheralVascularDiseasePresentInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C66923
UMLS 2011AA ObjectClass
C1881056
Does the patient have a history of arterial thrombotic event within the past 12 months
Descrição

ArteryThrombosisPatientPreviousYearPersonalMedicalHistoryInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C26891
NCI Thesaurus ObjectClass-3
C12372
NCI Thesaurus Property
C25627
NCI Thesaurus Property-2
C29848
NCI Thesaurus Property-3
C18772
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0332119
UMLS CUI-2
C1869078
Does the patient have a serious non-healing wound, skin ulcers or bone fracture?
Descrição

PatientWoundHistoryInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?
Descrição

PatientGastrointestinalHistoryUlcerationInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Does the patient meet all other eligibility criteria?
Descrição

PatientAdditionalClinicalTrialEligibilityCriteriaInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25406
UMLS 2011AA Property
C1524062
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
In the opinion of the investigator, is the patient eligible?
Descrição

Eligibility for trial

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171

Similar models

Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header
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)
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)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Affiliate Name
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician of Record (physician to whom subsequent vials will be sent must have a valid FDA number)
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (Month Day Year)
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)
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)
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)
PatientSocialSecurityNumber
Item
Patient Social Security Number (USA only)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
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)
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)
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)
CL Item
Patient Is Unsure Of Their Race (Unknown)
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)
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 & Private)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid & Medicare)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (incl. 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)
Item
Ethnicity
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29933 (NCI Thesaurus Property)
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)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Non-Hispanic)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Patient Is Unsure Of Their Ethnicity (Unknown)
Item
Country of Residence (if not 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)
Code List
Country of Residence (if not USA)
CL Item
Canada (Canada)
C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)
CL Item
Australia (Australia)
C16311 (NCI Thesaurus)
C0004340 (UMLS 2011AA)
CL Item
Mexico (Mexico)
C16850 (NCI Thesaurus)
C0025885 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Puerto Rico (Puerto Rico)
C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)
PatientAddressPostalCode
Item
Patient's 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)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Performance Status
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
CL Item
1 (Restricted in physically strenuous activity but ambulatory (K 70-80))
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))
CL Item
3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (Completely disabled (K 10-20))
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
CL Item
Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
CL Item
Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
Item Group
Patient characteristics
C0815172 (UMLS CUI-1)
Patient Height
Item
Patient Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
Patient Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
Code List
Patient Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Birth Date
Item
Patient's Date of Birth (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
Surgery Date
Item
Date of Surgery (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
TreatmentPlannedDate
Item
Date of Proposed Treatment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
LymphNodeExaminedCount
Item
Lymph Nodes Number Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Lymph Nodes Number Positive
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
BloodPressure,Systolic
Item
Blood Pressure Systolic (Report the Most Recent Blood Pressure)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Bloodpressure,Diastolic
Item
Blood Pressure Diastolic (Report the Most Recent Blood Pressure)
text
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS 2011AA ObjectClass)
Item
Menopausal status (Females only)
integer
C16960 (NCI Thesaurus ObjectClass)
C3231 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0455962 (UMLS CUI-1)
Code List
Menopausal status (Females only)
CL Item
Postmenopausal (1)
C0232970 (UMLS CUI-1)
CL Item
Premenopausal (2)
C0232969 (UMLS CUI-1)
Creatinine
Item
Serum Creatinine Patient Value
float
C16960 (NCI Thesaurus ObjectClass)
C13325 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0201976 (UMLS CUI-1)
Creatinine, serum ULN
Item
Serum Creatinine Upper Limit of Lab Normal (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
UrinaryCreatinineProteinAssessmentValue
Item
Urine Protein/Creatinine Ratio
float
C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Laboratory Procedure Date
Item
Date of Measurement (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
UrinaryProteinCollectionValue
Item
Protein from 24 hour Urine Collection (g)
float
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
Tissue donor for cancer research
Item
Your blood and tissue samples may be kept by the NSABP for use in this study and future research to learn about, prevent, detect, or treat cancer.
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C0040288 (UMLS CUI-1)
C1516225 (UMLS CUI-2)
Tissue donor for research
Item
Your blood and tissue samples may be used for research about other health problems (for example: causes of heart disease, osteoporosis, diabetes).
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)
C0040288 (UMLS CUI-1)
C0242481 (UMLS CUI-2)
Consent to contact patient
Item
Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research.
boolean
C16960 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI-1)
C2051501 (UMLS CUI-2)
Consent to collect blood
Item
Your blood samples may be collected and sent to Genetech, Inc. for bevacizumab antibody testing.
boolean
C38147 (NCI Thesaurus ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C25453 (NCI Thesaurus Property-2)
Item Group
C-08 Eligibility Checklist
C0013893 (UMLS CUI-1)
PatientStudyRequirementInd-2
Item
Does the patient have psychiatric or addictive disorders that would preclude the patient from meeting the study requirements?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (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)
Informed Consent
Item
Has the patient consented to participate in this study and signed and dated an approved consent form?
boolean
C0021430 (UMLS CUI-1)
OtherPatientColonTumorInd-2
Item
Does the patient have a colon tumor that is other than adenocarcinoma?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
CL053268 (NCI Metathesaurus Property)
Abdominal metastases
Item
Were there any isolated, distant, or non-contiguous intra-abdominal metastases (other than regional lymph nodes)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25626 (NCI Thesaurus Property)
C12664 (NCI Thesaurus ObjectClass)
C19151 (NCI Thesaurus Property-2)
C0854198 (UMLS CUI-1)
EnBlocResectionTumorCompleteInd-2
Item
Did the patient have an en bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy, i.e., curative resection?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
SystemicTherapyColorectalCarcinomaPerformedInd-2
Item
Has the patient received any systemic therapy or surgery (other than a decompressive colostomy or en bloc resection of tumor) for the current colon cancer?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C2955 (NCI Thesaurus Property-2)
C0009402 (UMLS 2011AA Property-2)
ColonTumorDistanceAnalVergeInd-2
Item
Is the distal extent of the lowest lying colon tumor greater or equal to 12 cm from the anal verge?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25419 (NCI Thesaurus Property)
C0227423 (UMLS 2011AA Property)
TumorHistologicallyConfirmedInd-2
Item
Does the patient have a histologically confirmed Stage II (T3, 4 N0 M0) or Stage III (any T N1,2 M0) tumor?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
Liver function
Item
Is there postoperative evidence of adequate hepatic function as described in the protocol?
boolean
C38147 (NCI Thesaurus ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C25518 (NCI Thesaurus Property)
C0232741 (UMLS CUI-1)
LaboratoryProcedurePost-OperativePlateletNormalResultInd-2
Item
Are the postoperative absolute granulocyte count and platelet count within the criteria set by the protocol?
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C14165 (NCI Thesaurus Property)
C0205307 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12520 (NCI Thesaurus Property-3)
C0005821 (UMLS 2011AA Property-3)
C25623 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCoagulationBloodInd-2
Item
Is the patient's PT (INR) within the criteria set by the protocol?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
NeuropathyAdverseEventToxicityInd-2
Item
Does the patient have significant peripheral neuropathy defined in the NCI CTCAE v3.0 as a grade 2 or greater neurosensory or neuromotor toxicity?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Major surgery
Item
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?
boolean
C25190 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus Property)
C3671 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0679637 (UMLS CUI-1)
Uncontrolled hypertension
Item
Does the patient have uncontrolled hypertension?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25626 (NCI Thesaurus Property)
C3117 (NCI Thesaurus ObjectClass)
C48932 (NCI Thesaurus ObjectClass-2)
C1868885 (UMLS CUI-1)
Prior neoplasm
Item
Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated?
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C3262 (NCI Thesaurus Property)
C18772 (NCI Thesaurus Property-2)
C0455471 (UMLS CUI-1)
heart failure
Item
Does the patient have Class III or Class IV cardiac disease or symptomatic arrhythmia
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C7922 (NCI Thesaurus Property-2)
C0278962 (UMLS CUI-1)
history of Coronary artery disease
Item
Does the patient have a history of myocardial infarction or unstable angina within the past 12 months
boolean
C27996 (NCI Thesaurus ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C29848 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1956346 (UMLS CUI-1)
history of TIA
Item
Does the patient have a prior history of TIA or CVA
boolean
C29867 (NCI Thesaurus ObjectClass)
C50781 (NCI Thesaurus Property)
C3390 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0455536 (UMLS CUI-1)
HistoryofPeripheralVascularDiseasePresentInd-3
Item
Does the patient have a history of symptomatic peripheral vascular disease
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C66923 (NCI Thesaurus ObjectClass)
C1881056 (UMLS 2011AA ObjectClass)
History of arterial thrombotic event
Item
Does the patient have a history of arterial thrombotic event within the past 12 months
boolean
C16960 (NCI Thesaurus ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C12372 (NCI Thesaurus ObjectClass-3)
C25627 (NCI Thesaurus Property)
C29848 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0332119 (UMLS CUI-1)
C1869078 (UMLS CUI-2)
PatientWoundHistoryInd-2
Item
Does the patient have a serious non-healing wound, skin ulcers or bone fracture?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PatientGastrointestinalHistoryUlcerationInd-2
Item
Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
PatientAdditionalClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient meet all other eligibility criteria?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (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)

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