ID

43132

Beskrivning

N1048 Eligibility Checklist Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE19C52B-5D67-27CC-E040-BB89AD437F7F

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE19C52B-5D67-27CC-E040-BB89AD437F7F

Nyckelord

Versioner (3)
  1. 2012-08-27 2012-08-27 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT01515787 Eligibility - N1048 Eligibility Checklist - 3287509v1.0

Engelsk

NCCTG through Alliance for Clinical Trials in Oncology ("Alliance")

1 Formulär  
Protocol Administration
Beskrivning

Protocol Administration

Date Informed Consent Signed
Beskrivning

InformedConsentFormSignedDate

Datatyp

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
Required Characteristics
Beskrivning

Required Characteristics

Age >= 18 years (at diagnosis)
Beskrivning

PatientAgeInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Age (>=18)
Beskrivning

PatientAgeYearCount

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Diagnosis of rectal adenocarcinoma
Beskrivning

ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C2852
UMLS 2011AA ObjectClass
C0001418
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25526
UMLS 2011AA Property-2
C0205462
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Measurable disease as defined in Section 11.0
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1513041
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C37894
ECOG performance status (PS) 0, 1, or 2
Beskrivning

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
Beskrivning

PersonStandardTreatmentRegimenOptionsClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus Property-2
C44275
UMLS 2011AA Property-2
C1442989
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C25374
UMLS 2011AA Property-4
C1518601
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
Beskrivning

PersonNoSphincterResectedClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C28381
UMLS 2011AA Property-2
C1409894
NCI Thesaurus Property-3
C25654
UMLS 2011AA Property-3
C1521996
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Primary surgeon is credentialed in Total Mesorectal Excision (TME) by the Alliance Surgery Committee (see Appendix IX)
Beskrivning

SurgeonTotalMesorectalExcisionCertificationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C18071
UMLS 2011AA ObjectClass
C0582175
NCI Thesaurus Property
C16180
UMLS 2011AA Property
C1273428
NCI Thesaurus Property-2
C43610
UMLS 2011AA Property-2
C0007836
Clinical Stage: T2N1, T3N0, T3N1. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT scan of the chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS).
Beskrivning

PersonStageEvaluationClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C16899
UMLS 2011AA Property-3
C1300072
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Preoperative proctoscopy with tumor tissue evident between 5 to 12 cm from the anal verge, inclusive.
Beskrivning

PersonPreoperativeProctoscopyClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C54732
UMLS 2011AA Property
C0445204
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C17012
UMLS 2011AA Property-3
C0033251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
The following laboratory values obtained <= 28 days prior to registration
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest laboratory test date (Note: These dates pertain to the following labs only)
Beskrivning

LaboratoryProcedureEvaluationPerformedFirstDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Latest laboratory test date (Note: These dates pertain to the following labs only)
Beskrivning

LaboratoryProcedureEvaluationPerformedMostRecentDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Absolute neutrophil count (ANC) >=1,500/mm^3
Beskrivning

LaboratoryProcedureNeutrophilResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ANC (>=1,500/mm^3)
Beskrivning

ANC

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0948762
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Platelet count >= 100,000/mm^3
Beskrivning

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C51951
UMLS 2011AA Property
C0032181
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Platelet count (>= 100,000/mm^3)
Beskrivning

Platelets

Datatyp

float

Måttenheter
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Hemoglobin >8 g/dL
Beskrivning

HematologyHemoglobinAssessmentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
Hemoglobin (>8 g/dL)
Beskrivning

LaboratoryProcedureHemoglobinResultSpecifiedValue

Datatyp

float

Måttenheter
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
Total bilirubin <=1.5 x upper limit of normal (ULN)
Beskrivning

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total Bilirubin (<=1.5 x ULN)
Beskrivning

Bilirubin, Total

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total Bilirubin ULN
Beskrivning

Bilirubin, Total ULN

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
SGOT (AST) <=3 x ULN
Beskrivning

SerumAspartateAminotransferaseMeasurementHepaticWithinProtocolUpperLimitofNormalLabInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass-2
C61018
UMLS 2011AA ObjectClass-2
C1261155
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
SGOT (AST) (<=3 x ULN)
Beskrivning

SGOT (AST)

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201899
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGOT (AST) ULN
Beskrivning

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT (ALT) <=3 x ULN
Beskrivning

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass-2
C25293
UMLS 2011AA ObjectClass-2
C0376147
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
SGPT (ALT) (<=3 x ULN)
Beskrivning

SGPT (ALT)

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGPT (ALT) ULN
Beskrivning

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Creatinine <=1.5 x ULN
Beskrivning

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Creatinine (<=1.5 x ULN)
Beskrivning

Creatinine, Serum

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Creatinine ULN
Beskrivning

Creatinine, serum ULN

Datatyp

float

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
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
Beskrivning

PatientNegativePregnancyTestIndicator

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Negative pregnancy test date (If a woman of childbearing potential)
Beskrivning

PatientNegativePregnancyTestDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Patient of child-bearing potential is willing to employ adequate contraception
Beskrivning

ContraceptionAgreementInd

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C37932
UMLS 2011AA ObjectClass
C0700589
NCI Thesaurus Property
C25369
UMLS 2011AA Property
C0680240
Provide informed written consent
Beskrivning

PatientConsentAbilityInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C78209
UMLS 2011AA Property-2
C0085732
Willing to return to enrolling medical site for all study visits
Beskrivning

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Exclusion Criteria - All Responses In Section Below Must Be "no."
Beskrivning

Exclusion Criteria - All Responses In Section Below Must Be "no."

Clinical T4 tumors
Beskrivning

PersonT4StageFindingClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C48732
UMLS 2011AA Property
C0475751
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
Primary surgeon indicates need for abdominaloperineal (APR) at baseline
Beskrivning

PersonAbdominoperinealResectionClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C91826
Evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan
Beskrivning

PersonMalignantNeoplasmMesorectalClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C25565
UMLS 2011AA Property-3
C1513155
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Tumor is causing symptomatic bowel obstruction
Beskrivning

PersonBowelObstructionClinicalTrialEligibilityCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9175
UMLS 2011AA Property
C0021843
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
Chemotherapy within 5 years prior to registration (Hormonal therapy is allowable if the disease-free interval is >= 5 years)
Beskrivning

PriorChemotherapyAdministeredInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Any prior pelvic radiation
Beskrivning

PriorRTPelvicAdministeredInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25399
UMLS 2011AA Property
C0030797
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other invasive malignancy <= 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix
Beskrivning

PatientNeoplasmPersonalMedicalHistoryInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception.
Beskrivning

PatientPhysicalExaminationPregnancyBreastFeedingContraindicatedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C20989
UMLS 2011AA ObjectClass-2
C0031809
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property-2
C37933
UMLS 2011AA Property-2
C1444657
NCI Thesaurus Property-3
C25596
UMLS 2011AA Property-3
C0006147
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Co-morbid systemic illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Beskrivning

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pre-registration Check
Beskrivning

Pre-registration Check

Consent form signed and dated
Beskrivning

InformedConsentFormSignedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
Beskrivning

PatientHealthRecordIndicator

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25178
UMLS 2011AA Property
C0018684
Date of authorization (If a USA institution)
Beskrivning

HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25168
UMLS 2011AA Property
C0040288
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property-2
C41192
UMLS 2011AA Property-2
C1524004
Treatment cannot begin prior to registration and must begin <=21 days after registration
Beskrivning

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pretreatment tests/procedures must be completed <= 28 days prior to registration (see Section 4.0)
Beskrivning

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C45513
UMLS 2011AA Property-4
C1711411
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest pretreatment test/procedure date (NOTE: The earliest pretreatment test date must be less than or equal to the earliest laboratory test date and the latest pretreatment test date must be greater than or equal to the latest laboratory test date.)
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Latest pretreatment test/procedure date
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
All required baseline conditions must be documented and graded (see Section 10.51)
Beskrivning

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25356
UMLS 2011AA Property-3
C1301725
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Treatment on this protocol must commence at the accruing membership site under the supervision of an Alliance or CTSU member physician
Beskrivning

ManagementNorthCentralCancerTreatmentGroupTherapyInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass-2
C61372
UMLS 2011AA ObjectClass-2
C1273870
Ran
Beskrivning

Ran

Patient has given permission to the Alliance to store and use his/her blood samples for use in future research to learn about, prevent, or treat cancer
Beskrivning

BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission to the Alliance to store and use his/her blood samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Beskrivning

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission to the Alliance to give his/her stored blood samples for use in future research to outside researchers
Beskrivning

PersonSpecimenExternalInvestigatorBloodSampleConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25936
UMLS 2011AA Property-3
C0035173
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C17610
UMLS 2011AA Property-5
C0178913
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to the Alliance to collect and store his/her tissue samples for use in future research to learn about, prevent, or treat cancer
Beskrivning

PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C16203
UMLS 2011AA Property-5
C1516654
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to the Alliance to collect and store his/her tissue samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Beskrivning

TissueSpecimenResearchConsentUnrelatedInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25328
UMLS 2011AA ValueDomain-2
C0445356
Patient has given permission for the Alliance to give his/her stored tissue samples for use in future research to outside researchers
Beskrivning

PersonSpecimenExternalInvestigatorTissueSampleConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25936
UMLS 2011AA Property-3
C0035173
NCI Thesaurus Property-4
C19697
UMLS 2011AA Property-4
C1292533
NCI Thesaurus Property-5
C25460
UMLS 2011AA Property-5
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Grouping Factor
Beskrivning

Grouping Factor

ECOG Performance Status
Beskrivning

PatientPerformanceStatusStratificationType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20641
UMLS 2011AA Property
C1518965
NCI Thesaurus Property-2
C25689
UMLS 2011AA Property-2
C1514983
Tillbaka till toppen

Similar models

NCCTG through Alliance for Clinical Trials in Oncology ("Alliance")

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Protocol Administration
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)
PatientAgeInd-2
Item
Age >= 18 years (at diagnosis)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
PatientAgeYearCount
Item
Age (>=18)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2
Item
Diagnosis of rectal adenocarcinoma
boolean
C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Measurable Disease
Item
Measurable disease as defined in Section 11.0
boolean
C38148 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
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)
PersonStandardTreatmentRegimenOptionsClinicalTrialEligibilityCriteriaInd-2
Item
For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C44275 (NCI Thesaurus Property-2)
C1442989 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25374 (NCI Thesaurus Property-4)
C1518601 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonNoSphincterResectedClinicalTrialEligibilityCriteriaInd-2
Item
Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C28381 (NCI Thesaurus Property-2)
C1409894 (UMLS 2011AA Property-2)
C25654 (NCI Thesaurus Property-3)
C1521996 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SurgeonTotalMesorectalExcisionCertificationInd-2
Item
Primary surgeon is credentialed in Total Mesorectal Excision (TME) by the Alliance Surgery Committee (see Appendix IX)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)
C16180 (NCI Thesaurus Property)
C1273428 (UMLS 2011AA Property)
C43610 (NCI Thesaurus Property-2)
C0007836 (UMLS 2011AA Property-2)
PersonStageEvaluationClinicalTrialEligibilityCriteriaInd-2
Item
Clinical Stage: T2N1, T3N0, T3N1. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT scan of the chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS).
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus Property-3)
C1300072 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPreoperativeProctoscopyClinicalTrialEligibilityCriteriaInd-2
Item
Preoperative proctoscopy with tumor tissue evident between 5 to 12 cm from the anal verge, inclusive.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus Property)
C0445204 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C17012 (NCI Thesaurus Property-3)
C0033251 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
The following laboratory values obtained <= 28 days prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedFirstDate
Item
Earliest laboratory test date (Note: These dates pertain to the following labs only)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureEvaluationPerformedMostRecentDate
Item
Latest laboratory test date (Note: These dates pertain to the following labs only)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureNeutrophilResultInd-2
Item
Absolute neutrophil count (ANC) >=1,500/mm^3
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ANC
Item
ANC (>=1,500/mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
Platelet count >= 100,000/mm^3
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Platelets
Item
Platelet count (>= 100,000/mm^3)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
HematologyHemoglobinAssessmentInd-2
Item
Hemoglobin >8 g/dL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (>8 g/dL)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2
Item
Total bilirubin <=1.5 x upper limit of normal (ULN)
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Bilirubin, Total
Item
Total Bilirubin (<=1.5 x ULN)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total ULN
Item
Total Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
SerumAspartateAminotransferaseMeasurementHepaticWithinProtocolUpperLimitofNormalLabInd-2
Item
SGOT (AST) <=3 x ULN
boolean
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C61018 (NCI Thesaurus ObjectClass-2)
C1261155 (UMLS 2011AA ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SGOT (AST)
Item
SGOT (AST) (<=3 x ULN)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2
Item
SGPT (ALT) <=3 x ULN
boolean
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus ObjectClass-2)
C0376147 (UMLS 2011AA ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SGPT (ALT)
Item
SGPT (ALT) (<=3 x ULN)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
Item
Creatinine <=1.5 x ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Creatinine, Serum
Item
Creatinine (<=1.5 x ULN)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Creatinine, serum ULN
Item
Creatinine ULN
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)
Item
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.18
Code List
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PatientNegativePregnancyTestDate
Item
Negative pregnancy test date (If a woman of childbearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
ContraceptionAgreementInd
Item
Patient of child-bearing potential is willing to employ adequate contraception
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
PatientConsentAbilityInd-2
Item
Provide informed written consent
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C78209 (NCI Thesaurus Property-2)
C0085732 (UMLS 2011AA Property-2)
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
Item
Willing to return to enrolling medical site for all study visits
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Exclusion Criteria - All Responses In Section Below Must Be "no."
PersonT4StageFindingClinicalTrialEligibilityCriteriaInd-2
Item
Clinical T4 tumors
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C48732 (NCI Thesaurus Property)
C0475751 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
PersonAbdominoperinealResectionClinicalTrialEligibilityCriteriaInd-2
Item
Primary surgeon indicates need for abdominaloperineal (APR) at baseline
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C91826 (NCI Thesaurus Property-2)
PersonMalignantNeoplasmMesorectalClinicalTrialEligibilityCriteriaInd-2
Item
Evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25565 (NCI Thesaurus Property-3)
C1513155 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonBowelObstructionClinicalTrialEligibilityCriteriaInd-2
Item
Tumor is causing symptomatic bowel obstruction
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9175 (NCI Thesaurus Property)
C0021843 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
PriorChemotherapyAdministeredInd-3
Item
Chemotherapy within 5 years prior to registration (Hormonal therapy is allowable if the disease-free interval is >= 5 years)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorRTPelvicAdministeredInd-3
Item
Any prior pelvic radiation
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25399 (NCI Thesaurus Property)
C0030797 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
Other invasive malignancy <= 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientPhysicalExaminationPregnancyBreastFeedingContraindicatedInd-2
Item
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. - 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)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
Item
Co-morbid systemic illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Pre-registration Check
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)
Item
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
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.32
Code List
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C48660 (NCI Thesaurus-3)
C1272460 (UMLS 2011AA-4)
HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
Item
Date of authorization (If a USA institution)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25168 (NCI Thesaurus Property)
C0040288 (UMLS 2011AA Property)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property-2)
C1524004 (UMLS 2011AA Property-2)
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
Item
Treatment cannot begin prior to registration and must begin <=21 days after registration
boolean
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureVerificationInd-2
Item
Pretreatment tests/procedures must be completed <= 28 days prior to registration (see Section 4.0)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C45513 (NCI Thesaurus Property-4)
C1711411 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest pretreatment test/procedure date (NOTE: The earliest pretreatment test date must be less than or equal to the earliest laboratory test date and the latest pretreatment test date must be greater than or equal to the latest laboratory test date.)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2
Item
All required baseline conditions must be documented and graded (see Section 10.51)
boolean
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25356 (NCI Thesaurus Property-3)
C1301725 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ManagementNorthCentralCancerTreatmentGroupTherapyInd-2
Item
Treatment on this protocol must commence at the accruing membership site under the supervision of an Alliance or CTSU member physician
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass-2)
C1273870 (UMLS 2011AA ObjectClass-2)
BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Patient has given permission to the Alliance to store and use his/her blood samples for use in future research to learn about, prevent, or treat cancer
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Patient has given permission to the Alliance to store and use his/her blood samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonSpecimenExternalInvestigatorBloodSampleConsentInd-2
Item
Patient has given permission to the Alliance to give his/her stored blood samples for use in future research 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)
C17610 (NCI Thesaurus Property-5)
C0178913 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2
Item
Patient has given permission to the Alliance to collect and store his/her tissue samples for use in future research to learn about, prevent, or treat cancer
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16203 (NCI Thesaurus Property-5)
C1516654 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
Patient has given permission to the Alliance to collect and store his/her tissue samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
PersonSpecimenExternalInvestigatorTissueSampleConsentInd-2
Item
Patient has given permission for the Alliance to give his/her stored tissue samples for use in future research 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)
C19697 (NCI Thesaurus Property-4)
C1292533 (UMLS 2011AA Property-4)
C25460 (NCI Thesaurus Property-5)
C1511481 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Grouping Factor
Item
ECOG Performance Status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20641 (NCI Thesaurus Property)
C1518965 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property-2)
C1514983 (UMLS 2011AA Property-2)
CL.43
Code List
ECOG Performance Status
CL Item
0 Or 1 (0 or 1)
CL Item
2 (2)
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