ID

43201

Beschreibung

CALGB 30506 Pre-Study/Surgical Resection Form Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5FE8C8A3-6705-BC07-E040-BB89AD4332A8

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5FE8C8A3-6705-BC07-E040-BB89AD4332A8

Stichworte

Versionen (4)
  1. 19.09.12 19.09.12 -
  2. 11.08.14 11.08.14 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
  4. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00863512 Pre-Study - CALGB 30506 Pre-Study/Surgical Resection Form - 2821782v1.0

Englisch

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes

1 Formulare  
Ccrr Module For Calgb 90202: Prostate Specific Antigen Form
Beschreibung

Ccrr Module For Calgb 90202: Prostate Specific Antigen Form

CALGB Form
Beschreibung

Form ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Vital Status
Beschreibung

Vital Status

ECOG Performance Status
Beschreibung

ECOG Performance Status

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Prior Treatment (for this cancer within the past 5 years)
Beschreibung

CancerPriorTreatmentInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C15368
Required Laboratory Values
Beschreibung

Required Laboratory Values

WBC (x 10^3 microL)
Beschreibung

Leukocytes (WBC)

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
ANC (x 10^3 microL)
Beschreibung

ANC

Datentyp

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
Granulocytes (%)
Beschreibung

LaboratoryProcedureGranulocyteResultPercentageValue

Datentyp

float

Maßeinheiten
  • %
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Platelets (PLT) (x 10^3 microL)
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 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
Bilirubin (mg/dl)
Beschreibung

LaboratoryProcedureTotalBilirubinResultValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
SGOT (AST) (UL)
Beschreibung

SGOT (AST)

Datentyp

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 (UL)
Beschreibung

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datentyp

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
Serum creatinine (mg/dl)
Beschreibung

Creatinine, Serum

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Serum Creatinine ULN
Beschreibung

Creatinine, serum ULN

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
mg/dL
Unnamed3
Beschreibung

Unnamed3

Smoking History
Beschreibung

Smoking history

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1519384
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C18772
Number pack years smoked (If former or current smoker, Pack year = number of packs smoked / day x number of years smoked)
Beschreibung

CigaretteSmokingHistoryPackYearAmount

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C25417
Pre-surgical Disease Status
Beschreibung

Pre-surgical Disease Status

Date of Chest X-Ray or CT scan (MM DD YYYY)
Beschreibung

PatientChestRadiographyComputedTomographyAssessmentDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C38103
UMLS 2011AA Property-2
C0039985
NCI Thesaurus Property-3
C17204
UMLS 2011AA Property-3
C0040405
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Clinical Size of Tumor (on chest/upper abdominal CT scan cm)
Beschreibung

PrimaryTumorSizeMeasurement

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
Clinical T Stage
Beschreibung

T Stage clinical

Datentyp

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
Beschreibung

N Stage clinical

Datentyp

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
MedDRA disease code
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
How were positive nodes ruled out (If nodes were suspicious for malignancy > 1 cm on pre-op CT or positive on PET scan)
Beschreibung

LymphNodeNegativeAssessmentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property-2
C38757
UMLS 2011AA Property-2
C1513916
Surgical Disease Status
Beschreibung

Surgical Disease Status

Did patient undergo surgical resection?
Beschreibung

SurgicalProcedureExcisionPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property-2
C15232
UMLS 2011AA Property-2
C0728940
Date of Resection (MM DD YYYY)
Beschreibung

PatientSurgicalResectionDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25698
NCI Thesaurus Property-2
C15232
UMLS 2011AA Property
C0728940
Specify reason (If no Mark all that apply with an X.)
Beschreibung

LungIncompleteSurgicalProcedureReasonType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C49160
UMLS 2011AA ObjectClass
C0205257
NCI Thesaurus ObjectClass-2
C12468
UMLS 2011AA ObjectClass-2
C0024109
NCI Thesaurus ObjectClass-3
C15329
UMLS 2011AA ObjectClass-3
C0543467
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Beschreibung

LungIncompleteSurgicalProcedureReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C49160
UMLS 2011AA ObjectClass
C0205257
NCI Thesaurus ObjectClass-2
C12468
UMLS 2011AA ObjectClass-2
C0024109
NCI Thesaurus ObjectClass-3
C15329
UMLS 2011AA ObjectClass-3
C0543467
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Histology (Mark one with an X.)
Beschreibung

Histologic Type

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0449574
NCI Thesaurus ObjectClass-2
C12468
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ValueDomain-2
C25526
Other specify
Beschreibung

Histologic Type, other

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Pathologic Primary Tumor Size (on path report cm)
Beschreibung

PathologicTumorPrimarySizeMeasurement

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25610
UMLS 2011AA ObjectClass-2
C1521733
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus Property-2
C25681
UMLS 2011AA Property-2
C0456389
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
T stage (Patients with tumors < 1.7 cm, T3-4 or N1-2 disease should NOT be registered to study)
Beschreibung

PatientLungPathologicTStageClinicalTrialEligibilityCriteriaStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C12468
UMLS 2011AA Property-2
C0024109
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C25728
UMLS 2011AA Property-4
C0475455
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
N stage (Patients with tumors < 1.7 cm, T3-4 or N1-2 disease should NOT be registered to study)
Beschreibung

PatientLungPathologicNStageClinicalTrialEligibilityCriteriaStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C12468
UMLS 2011AA Property-2
C0024109
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C25580
UMLS 2011AA Property-4
C0456532
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Planned Treatment
Beschreibung

Planned Treatment

Assigned Treatment Arm
Beschreibung

Protocol Treatment Arm

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25284
Specify
Beschreibung

PatientNoRandomizationSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C25196
UMLS 2011AA Property-2
C0034656
Contact Information
Beschreibung

Contact Information

Medical oncologist's name
Beschreibung

MedicalOncologistPersonIdentifierName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C17838
UMLS 2011AA ObjectClass-2
C1555767
Surgeon Name
Beschreibung

SurgeonName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C18071
UMLS 2011AA ObjectClass
C0582175
E-mail
Beschreibung

TreatingPhysicianPersonEmailAddressText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C51883
UMLS 2011AA ObjectClass-2
C1710470
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Phone
Beschreibung

TreatingPhysicianPhoneNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Footer Module
Beschreibung

Footer Module

Completed by
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Originally Completed (MM DD YYYY)
Beschreibung

Form Completion Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
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INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Ccrr Module For Calgb 90202: Prostate Specific Antigen Form
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Vital Status
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
ECOG Performance Status
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)
CancerPriorTreatmentInd-3
Item
Prior Treatment (for this cancer within the past 5 years)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
Item Group
Required Laboratory Values
Leukocytes (WBC)
Item
WBC (x 10^3 microL)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
ANC
Item
ANC (x 10^3 microL)
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)
LaboratoryProcedureGranulocyteResultPercentageValue
Item
Granulocytes (%)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Platelets (PLT) (x 10^3 microL)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (mg/dl)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SGOT (AST)
Item
SGOT (AST) (UL)
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 (UL)
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)
Creatinine, Serum
Item
Serum creatinine (mg/dl)
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, serum ULN
Item
Serum 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 Group
Unnamed3
Item
Smoking History
text
C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
CL.4
Code List
Smoking History
CL Item
Never Smoked (Never smoked)
CL Item
Smoked In The Past (Smoked in the past)
CL Item
Currently Smoking (Currently smoking)
CigaretteSmokingHistoryPackYearAmount
Item
Number pack years smoked (If former or current smoker, Pack year = number of packs smoked / day x number of years smoked)
text
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
Item Group
Pre-surgical Disease Status
PatientChestRadiographyComputedTomographyAssessmentDate
Item
Date of Chest X-Ray or CT scan (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38103 (NCI Thesaurus Property-2)
C0039985 (UMLS 2011AA Property-2)
C17204 (NCI Thesaurus Property-3)
C0040405 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PrimaryTumorSizeMeasurement
Item
Clinical Size of Tumor (on chest/upper abdominal CT scan cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
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.5
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)
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.6
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)
MedDRACode
Item
MedDRA disease code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
How were positive nodes ruled out (If nodes were suspicious for malignancy > 1 cm on pre-op CT or positive on PET scan)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C38757 (NCI Thesaurus Property-2)
C1513916 (UMLS 2011AA Property-2)
CL.7
Code List
How were positive nodes ruled out (If nodes were suspicious for malignancy > 1 cm on pre-op CT or positive on PET scan)
CL Item
Anterior Mediatinoscopy (chamberlain) (Anterior Mediatinoscopy (Chamberlain))
CL Item
Ebus-fna (EBUS-FNA)
CL Item
Eus-fna (EUS-FNA)
CL Item
Mediastinoscopy (Mediastinoscopy)
C16829 (NCI Thesaurus)
C0025065 (UMLS 2011AA)
CL Item
Thoracotomy (Open thoracotomy)
CL Item
Transbronchial Aspirate; No Ebus (Transbronchial aspirate; No EBUS)
CL Item
Ttnb (TTNB)
CL Item
Vats Node Biopsy (VATS node biopsy)
Item Group
Surgical Disease Status
SurgicalProcedureExcisionPerformedInd-2
Item
Did patient undergo surgical resection?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property-2)
PatientSurgicalResectionDate
Item
Date of Resection (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property)
Item
Specify reason (If no Mark all that apply with an X.)
text
C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.9
Code List
Specify reason (If no Mark all that apply with an X.)
CL Item
Positive Nodes (Positive nodes)
CL Item
Benign Mass (Benign mass)
CL Item
Carcinoid Tumor (Carcinoid)
C2915 (NCI Thesaurus)
C0007095 (UMLS 2011AA)
CL Item
Tumor < 1.70 Cm (Tumor < 1.70 cm)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LungIncompleteSurgicalProcedureReasonSpecify
Item
Other, specify
text
C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Histology (Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0449574 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
CL.10
Code List
Histology (Mark one with an X.)
CL Item
Non-small Cell Lung Cancer (nsclc), Nos (Non-small cell lung cancer NOS)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenosquamous Carcinoma (Adenosquamous)
C3727 (NCI Thesaurus)
C0206623 (UMLS 2011AA)
CL Item
Other (Other specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
PathologicTumorPrimarySizeMeasurement
Item
Pathologic Primary Tumor Size (on path report cm)
float
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS 2011AA ObjectClass-2)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property-2)
C0456389 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item
T stage (Patients with tumors < 1.7 cm, T3-4 or N1-2 disease should NOT be registered to study)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C12468 (NCI Thesaurus Property-2)
C0024109 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25728 (NCI Thesaurus Property-4)
C0475455 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.11
Code List
T stage (Patients with tumors < 1.7 cm, T3-4 or N1-2 disease should NOT be registered to study)
CL Item
T1 (T1)
C1179687 (NCI Metathesaurus)
CL Item
T2 (T2)
CL Item
T3-4 (T3-4)
Item
N stage (Patients with tumors < 1.7 cm, T3-4 or N1-2 disease should NOT be registered to study)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C12468 (NCI Thesaurus Property-2)
C0024109 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25580 (NCI Thesaurus Property-4)
C0456532 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.12
Code List
N stage (Patients with tumors < 1.7 cm, T3-4 or N1-2 disease should NOT be registered to study)
CL Item
N0 (N0)
CL Item
N1 (N1)
CL Item
N2 (N2)
Item Group
Planned Treatment
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
CL.13
Code List
Assigned Treatment Arm
CL Item
Regimen 1: Vinorelbine And Cisplatin (Regimen 1: Vinorelbine and Cisplatin)
CL Item
Regimen 2: Docetaxel And Cisplatin (Regimen 2: Docetaxel and Cisplatin)
CL Item
Regimen 3: Gemcitabine And Cisplatin (Regimen 3: Gemcitabine and Cisplatin)
CL Item
Randomized To Observation (Randomized to observation)
CL Item
Patient Refused To Be Randomized (Patient refused to be randomized)
CL Item
Patient Refused Assigned Treatment After Randomization (Patient refused assigned treatment after randomization)
CL Item
Patient Not Randomized Due To Ineligibility (Patient not randomized due to ineligibility)
CL Item
Patient Not Randomized For Other Reason (Patient not randomized for other reason)
PatientNoRandomizationSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25196 (NCI Thesaurus Property-2)
C0034656 (UMLS 2011AA Property-2)
Item Group
Contact Information
MedicalOncologistPersonIdentifierName
Item
Medical oncologist's name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17838 (NCI Thesaurus ObjectClass-2)
C1555767 (UMLS 2011AA ObjectClass-2)
SurgeonName
Item
Surgeon Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)
TreatingPhysicianPersonEmailAddressText
Item
E-mail
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C51883 (NCI Thesaurus ObjectClass-2)
C1710470 (UMLS 2011AA ObjectClass-2)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
TreatingPhysicianPhoneNumber
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
Item Group
Footer Module
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Date Form Originally Completed (MM DD YYYY)
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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