ID

43213

Descrição

Z4032 Registration Worksheet NCT00107172 Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F20F53D3-C88B-6847-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F20F53D3-C88B-6847-E034-0003BA3F9857

Palavras-chave

Versões (6)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 26/06/2015 26/06/2015 -
  4. 25/07/2015 25/07/2015 - Martin Dugas
  5. 29/07/2015 29/07/2015 - Martin Dugas
  6. 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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Registration Worksheet NSCLC Z4032 NCT00107172

Inglês

No Instruction available.

1 Formulários  
  1. StudyEvent: Z4032 Registration Worksheet
    1. No Instruction available.
Header Module
Descrição

Header Module

Alias
UMLS CUI-1
C1320722
Visit
Descrição

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C19712
NCI Thesaurus ObjectClass-2
C25716
UMLS CUI-1
C3641100
Patient ID (Pt. ID issued during registration or previously issued patient ID)
Descrição

Patient Study ID

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Initials
Descrição

Patient Initials

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution No.
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
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
Registration Date
Descrição

PatientRegistrationDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Has patient previously been registered to an ACOSOG study
Descrição

PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C16124
NCI Thesaurus Property
C19712
NCI Metathesaurus Property
CL238692
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1-1
C2242969
Coordinating Group Protocol No.
Descrição

Protocol ID Coordinating Group

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient demographics
Descrição

Patient demographics

Alias
UMLS CUI-1
C1704791
Patient date of birth
Descrição

Patient date of birth

Tipo de dados

date

Unidades de medida
  • DD.MM.YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
UMLS CUI-1-1
C0421451
DD.MM.YYYY
Gender
Descrição

Gender

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
UMLS CUI-1
C0079399
Race (Mark all that apply)
Descrição

Racial Group

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Ethnicity (Mark only one)
Descrição

Ethnic Group

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Method of payment (Mark all that apply)
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
Other, specify
Descrição

PatientPaymentSpecify

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Body weight
Descrição

Body weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C0005910
kg
Height
Descrição

Height

Tipo de dados

float

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0005890
cm
Patient 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
Postal code (Canada)
Descrição

CanadaAddressPostalCode

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16380
UMLS 2011AA ObjectClass
C0006823
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Other Country Postal Code (Other)
Descrição

PatientOtherCountryAddressPostalCode

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25464
UMLS 2011AA Property-2
C0454664
NCI Thesaurus Property-3
C25407
UMLS 2011AA Property-3
C1442065
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Country of Residence
Descrição

Country of current residence

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3258975
NCI Thesaurus ValueDomain
C25464
NCI Thesaurus Property
C25407
NCI Thesaurus ValueDomain-2
C42614
Date Informed Consent Signed
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
HIPAA Authorization form (OR)
Descrição

HealthInsurancePortabilityandAccountabilityActAuthorizationStatus

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date (If signed as a separate form,)
Descrição

PatientSignedDischargeMedicalRecordDate

Tipo de dados

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Minor criteria met (check all that apply)
Descrição

PatientMinorEligibilityType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C45367
UMLS 2011AA Property-2
C0205165
Baseline Performace Status (ECOG/modified Zubrod scale)
Descrição

BaselinePerformanceStatusEasternCooperativeOncologyGroupScale

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Metathesaurus ObjectClass
CL092952
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Pre-operative Criteria
Descrição

Pre-operative Criteria

Patient must have a suspicious lung nodule for clinical stage I NSCLC
Descrição

PatientSuspiciousLungNoduleInd-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
C0750493
NCI Metathesaurus Property-2
C0034079
Patient must have a mass <= 3 cm maximum diameter by CT size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
Descrição

PatientSmallTumorInd-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
C25376
UMLS 2011AA Property
C0700321
NCI Metathesaurus Property
CL053268
Patient must have a CT scan of the chest with upper abdomen within 60 days prior to pre-registration
Descrição

PatientPriorChestComputedTomographyInd-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
C25629
UMLS 2011AA Property
C0332152
NCI Metathesaurus Property
C0202823
ECOG performance status (PS) 0, 1, or 2 (Patient must have an )
Descrição

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C20989
NCI Thesaurus ObjectClass
C25491
NCI Metathesaurus ObjectClass
CL092952
UMLS CUI-1-1
C1512162
Patient must meet at least one major criteria or meet a minimum or two minor criteria as described below (Major Criteria - FEV1 <= 50%; DLCO <= 50%)
Descrição

PatientStudyCriteriaInd-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
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property-2
C25466
UMLS 2011AA Property-2
C0243161
Patient must have not had previous intra-thoracic radiation therapy
Descrição

PatientThoracicRadiationTherapyInd-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
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property-2
C13360
UMLS 2011AA Property-2
C0817096
Women of child-bearing potential must have negative serum or urine pregnancy test
Descrição

PatientNegativePregnancyTestIndicator

Tipo de dados

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
Patient, or the patient's legally acceptable representative, must provide a signed and dated written informed consent PRIOR to registration and any study-related procedures being performed
Descrição

PatientPriorInformedConsentInd-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
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C16735
UMLS 2011AA Property-2
C0021430
Patient or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of their protected health information (NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient)
Descrição

PatientAuthorizationConfidentialInformationInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
NCI Metathesaurus Property
C0009668
No prior invasive malignancies, unless disease-free for >= 5 years prior to pre-registration. (Exceptions: non-melanoma skin cancer, in-situ cancers)
Descrição

PatientNeoplasmPersonalMedicalHistoryInd-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
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Ct Scan Of Chest/upper Abdomen
Descrição

Ct Scan Of Chest/upper Abdomen

Type of imaging (Mark all that apply)
Descrição

ImagingMethodType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
Date of CT Scan (chest)
Descrição

DiagnosticComputedTomographyPerformedDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C25482
UMLS 2011AA ObjectClass-2
C0348026
Date of Abdominal CT Assessment (upper abdomen)
Descrição

AbdominalCTAssessmentDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus ObjectClass-2
C25342
UMLS 2011AA ObjectClass-2
C0000726
Pregnancy Test
Descrição

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test done
Descrição

PregnancyTestPerformedInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
Date of most recent test
Descrição

PatientMostRecentPregnancyTestDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Type of pregnancy test
Descrição

PregnancyLaboratoryProcedurePerformedType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
Pregnancy Test Not Performed Reason
Descrição

PregnancyLaboratoryProcedureNotPerformedReason

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Descrição

PregnancyLaboratoryProcedureNotPerformedSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Size of Nodule on CT scan
Descrição

ChestComputedTomographyNoduleSizeMeasurement

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus ObjectClass-2
C25389
UMLS 2011AA ObjectClass-2
C0817096
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
NCI Thesaurus Property-2
C3280
UMLS 2011AA Property-2
C0028259
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Clinical Stage
Descrição

Clinical Stage

Alias
UMLS CUI-1
C1300072
Clinical T Stage
Descrição

T Stage clinical

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0475455
NCI Thesaurus ObjectClass-2
C12468
UMLS CUI-2
C0205210
NCI Thesaurus Property
C25398
NCI Thesaurus Property-2
C25728
NCI Thesaurus ValueDomain
C16899
Clinical N Stage
Descrição

N Stage clinical

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0456532
NCI Thesaurus ObjectClass-2
C12468
UMLS CUI-2
C0205210
NCI Thesaurus Property
C25398
NCI Thesaurus Property-2
C25580
NCI Thesaurus ValueDomain
C16899
Clinical M Stage
Descrição

M Stage clinical

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0456533
NCI Thesaurus ObjectClass-2
C12468
UMLS CUI-2
C0205210
NCI Thesaurus Property
C25398
NCI Thesaurus Property-2
C25727
NCI Thesaurus ValueDomain
C16899
Pre-operative Pft's
Descrição

Pre-operative Pft's

Forced Expiratory Volume 1 (FEV1)
Descrição

LungForcedExpiratoryVolume1TestSpecifiedValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C38084
UMLS 2011AA Property-2
C0849974
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C38024
UMLS 2011AA ValueDomain-2
C0205369
Forced Expiratory Volume 1 (%Predicted FEV1)
Descrição

LungForcedExpiratoryVolume1TestPercentageValue

Tipo de dados

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C38084
UMLS 2011AA Property-2
C0849974
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Carbon Monoxide Diffusion (DLCO)
Descrição

LungCarbonMonoxideDiffusingCapabilityTestAssessmentPredictiveValuePercentageValue

Tipo de dados

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C12468
NCI Thesaurus Property
C20989
NCI Thesaurus Property-2
C38083
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
NCI Thesaurus ValueDomain-3
C16238
UMLS CUI-1-1
C1516251
%
Forced Vital Capacity (% predicted)
Descrição

VitalLungCapacityTestPercentageValue

Tipo de dados

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus ObjectClass-2
C18003
UMLS 2011AA ObjectClass-2
C0442732
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C25443
UMLS 2011AA Property-2
C1516240
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
Descrição

CaseReportFormInvestigatorReviewInd-2

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25936
UMLS 2011AA Property
C0035173
NCI Thesaurus Property-2
C42729
UMLS 2011AA Property-2
C1552617
Date of Investigator Signature
Descrição

Investigator Signature Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Footer Module
Descrição

Footer Module

Completed by
Descrição

Responsible Person Signature

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date Form Completed
Descrição

Date Form Completed

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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1 Formulários
  1. StudyEvent: Z4032 Registration Worksheet
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C25616 (NCI Thesaurus Property)
C19712 (NCI Thesaurus ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C3641100 (UMLS CUI-1)
CL.1
Code List
Visit
CL Item
Registration (Registration)
C25646 (NCI Thesaurus)
C1514821 (UMLS 2011AA)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
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)
PatientRegistrationDate
Item
Registration Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Previous study
Item
Has patient previously been registered to an ACOSOG study
boolean
C16960 (NCI Thesaurus ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C19712 (NCI Thesaurus Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C2242969 (UMLS CUI-1-1)
Protocol ID Coordinating Group
Item
Coordinating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Patient demographics
C1704791 (UMLS CUI-1)
Birth date
Item
Patient date of birth
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1-1)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS CUI-1)
CL.3
Code List
Gender
CL Item
Male (M)
C0086582 (UMLS CUI-1)
CL Item
Female (F)
C0086287 (UMLS CUI-1)
Item
Race (Mark all that apply)
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.4
Code List
Race (Mark all that apply)
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)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity (Mark only one)
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL.5
Code List
Ethnicity (Mark only one)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Method of payment (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL.6
Code List
Method of payment (Mark all that apply)
CL Item
Private Insurance (Private insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and private insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or veterans sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military sponsored)
CL Item
Veterans Sponsored (Veterans sponsored)
CL Item
Self Pay (no Insurance) (Self pay)
CL Item
No Means Of Payment (no Insurance) (No means of payment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientPaymentSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI-1)
PatientAddressPostalCode
Item
Patient Zip Code (USA)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CanadaAddressPostalCode
Item
Postal code (Canada)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PatientOtherCountryAddressPostalCode
Item
Other Country Postal Code (Other)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Country of current residence
Item
Country of Residence
text
C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
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)
Item
HIPAA Authorization form (OR)
text
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL.7
Code List
HIPAA Authorization form (OR)
CL Item
Included In Study Informed Consent (Included in Study Informed Consent)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If signed as a separate form,)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Minor criteria met (check all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C45367 (NCI Thesaurus Property-2)
C0205165 (UMLS 2011AA Property-2)
CL.8
Code List
Minor criteria met (check all that apply)
CL Item
Age >= 75 (Age >= 75)
CL Item
Modified Medical Research Council Dyspnea Scale >=3 (Modified Medical Research Council Dyspnea Scale >=3)
CL Item
Pco2 > 45 Mmhg (pCO2 > 45 mmHg)
CL Item
Poor Left Ventricular Function (Poor left ventricular function)
CL Item
Pulmonary Hypertension (Pulmonary hypertension)
C3120 (NCI Thesaurus)
C0020542 (UMLS 2011AA)
CL Item
Resting Or Exercise Arterial Po2 <= 55 Mmhg Or Spo2 <= 88% (Resting or exercise arterial pO2 <= 55 mmHg or SpO2 <= 88%)
Item
Baseline Performace Status (ECOG/modified Zubrod scale)
text
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL.9
Code List
Baseline Performace Status (ECOG/modified Zubrod scale)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item Group
Pre-operative Criteria
PatientSuspiciousLungNoduleInd-2
Item
Patient must have a suspicious lung nodule for clinical stage I NSCLC
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0750493 (NCI Metathesaurus Property)
C0034079 (NCI Metathesaurus Property-2)
PatientSmallTumorInd-2
Item
Patient must have a mass <= 3 cm maximum diameter by CT size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25376 (NCI Thesaurus Property)
C0700321 (UMLS 2011AA Property)
CL053268 (NCI Metathesaurus Property)
PatientPriorChestComputedTomographyInd-2
Item
Patient must have a CT scan of the chest with upper abdomen within 60 days prior to pre-registration
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C0202823 (NCI Metathesaurus Property)
ECOG assessment
Item
ECOG performance status (PS) 0, 1, or 2 (Patient must have an )
boolean
C38147 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1512162 (UMLS CUI-1-1)
PatientStudyCriteriaInd-2
Item
Patient must meet at least one major criteria or meet a minimum or two minor criteria as described below (Major Criteria - FEV1 <= 50%; DLCO <= 50%)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25466 (NCI Thesaurus Property-2)
C0243161 (UMLS 2011AA Property-2)
PatientThoracicRadiationTherapyInd-2
Item
Patient must have not had previous intra-thoracic radiation therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)
Item
Women of child-bearing potential must have negative serum or urine pregnancy test
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.16
Code List
Women of child-bearing potential must have negative serum or urine pregnancy test
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)
PatientPriorInformedConsentInd-2
Item
Patient, or the patient's legally acceptable representative, must provide a signed and dated written informed consent PRIOR to registration and any study-related procedures being performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16735 (NCI Thesaurus Property-2)
C0021430 (UMLS 2011AA Property-2)
PatientAuthorizationConfidentialInformationInd-3
Item
Patient or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of their protected health information (NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
C0009668 (NCI Metathesaurus Property)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
No prior invasive malignancies, unless disease-free for >= 5 years prior to pre-registration. (Exceptions: non-melanoma skin cancer, in-situ cancers)
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)
Item Group
Ct Scan Of Chest/upper Abdomen
Item
Type of imaging (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
CL.20
Code List
Type of imaging (Mark all that apply)
CL Item
Ct Scan Of Chest (CT scan of chest)
CL Item
Ct Scan Of Upper Abdomen, Including The Liver And Adrenal Glands (CT scan of upper abdomen, including the liver and adrenal glands)
DiagnosticComputedTomographyPerformedDate
Item
Date of CT Scan (chest)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass-2)
C0348026 (UMLS 2011AA ObjectClass-2)
AbdominalCTAssessmentDate
Item
Date of Abdominal CT Assessment (upper abdomen)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25342 (NCI Thesaurus ObjectClass-2)
C0000726 (UMLS 2011AA ObjectClass-2)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
PregnancyTestPerformedInd-2
Item
Pregnancy Test done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
PatientMostRecentPregnancyTestDate
Item
Date of most recent test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item
Type of pregnancy test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
CL.22
Code List
Type of pregnancy test
CL Item
Serum (Serum)
C13325 (NCI Thesaurus)
C0229671 (UMLS 2011AA)
CL Item
Urine (Urine)
C13283 (NCI Thesaurus)
C0042036 (UMLS 2011AA)
Item
Pregnancy Test Not Performed Reason
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.23
Code List
Pregnancy Test Not Performed Reason
CL Item
Patient Is Male (Patient is male)
CL Item
Patient Is Female But Is Not Of Childbearing Potential (Patient is female but is not of childbearing potential)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PregnancyLaboratoryProcedureNotPerformedSpecify
Item
Other, specify
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Size of Nodule on CT scan
text
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass-2)
C0817096 (UMLS 2011AA ObjectClass-2)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
CL.24
Code List
Size of Nodule on CT scan
CL Item
0 - 1.0 Cm (0 - 1.0 cm)
CL Item
1.1 - 2.0 Cm (1.1 - 2.0 cm)
CL Item
2.1 - 3.0 Cm (2.1 - 3.0 cm)
CL Item
> 3.0 Cm (> 3.0 cm)
Item Group
Clinical Stage
C1300072 (UMLS CUI-1)
Item
Clinical T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0475455 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25728 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL.25
Code List
Clinical T Stage
CL Item
Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)
CL Item
Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)
CL Item
Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)
Item
Clinical N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL.26
Code List
Clinical N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)
CL Item
Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)
Item
Clinical M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL.27
Code List
Clinical M Stage
CL Item
No Distant Metastasis (M0)
Item Group
Pre-operative Pft's
LungForcedExpiratoryVolume1TestSpecifiedValue
Item
Forced Expiratory Volume 1 (FEV1)
float
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property-2)
C0849974 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
LungForcedExpiratoryVolume1TestPercentageValue
Item
Forced Expiratory Volume 1 (%Predicted FEV1)
float
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property-2)
C0849974 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Carbon Monoxide Diffusing Capability Test
Item
Carbon Monoxide Diffusion (DLCO)
float
C12468 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C38083 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C16238 (NCI Thesaurus ValueDomain-3)
C1516251 (UMLS CUI-1-1)
VitalLungCapacityTestPercentageValue
Item
Forced Vital Capacity (% predicted)
float
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ObjectClass-2)
C0442732 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25443 (NCI Thesaurus Property-2)
C1516240 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
CL.28
Code List
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Investigator Signature Date
Item
Date of Investigator Signature
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Footer Module
Responsible Person Signature
Item
Completed by
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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