ID

2238

Beskrivning

CALGB: 140503 On-Study Form Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=218D3F85-A366-6278-E044-0003BA3F9857

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=218D3F85-A366-6278-E044-0003BA3F9857

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19 september 2012

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Lung Cancer NCT00499330 On-Study - CALGB: 140503 On-Study Form - 2537927v1.0

model
Detaljer

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...

1 Formulär

StudyEvent: CALGB: 140503 On-Study Form
1. 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...

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header

Item Group

Ccrr Module For Calgb 90202: Skeletal Survey Form

CALGBFormIdentifierNumber

Item

CALGB Form (C-1244)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientInitialsName

Item

Patient Initials (Last, First Middle)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Unnamed1

Item Group

Vital Status

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status (Mark one with an X.)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.2

Code List

ECOG Performance Status (Mark one with an X.)

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)

CancerPriorTreatmentInd-3

Item

Prior Treatment? (for this cancer)

text

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)

CL.3

Code List

Prior Treatment? (for this cancer)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorCancerDiagnosisInd-3

Item

Has the patient had a prior malignancy within the past 5 years (other than non-melanoma skin cancer or superficial bladder cancer)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.4

Code List

Has the patient had a prior malignancy within the past 5 years (other than non-melanoma skin cancer or superficial bladder cancer)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TumorLungAreaType

Item

Tumor Location Area

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property)
C0205146 (UMLS 2011AA Property)

CL.5

Code List

Tumor Location Area

CL Item

Upper Lobe (right) (Upper Lobe (right))

CL Item

Lower Lobe (right) (Lower Lobe (right))

CL Item

Lower Lobe (left) (Lower Lobe (left))

CL Item

Middle Lobe (right) (Middle Lobe (right))

CL Item

Upper Lobe (left) (Upper Lobe (left))

CL Item

Lingula (Lingula)

TumorLungPositionType

Item

Tumor Location, Zone (in lobe)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25339 (NCI Thesaurus Property)
C0733755 (UMLS 2011AA Property)

CL.6

Code List

Tumor Location, Zone (in lobe)

CL Item

Predominantly Peripheral (Predominantly peripheral)

CL Item

Predominantly Central (Predominantly central)

MalignantNeoplasmNecrosisInd-3

Item

Is necrosis present? (by presence of a low-attenuation component on CT)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C16897 (NCI Thesaurus Property)
C0027540 (UMLS 2011AA Property)

CL.7

Code List

Is necrosis present? (by presence of a low-attenuation component on CT)

CL Item

No (NO)

CL Item

Yes (YES)

PreoperativeNeedleBiopsyPerformedInd-2

Item

Was a pre-operative needle biopsy performed

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C54732 (NCI Thesaurus ObjectClass)
C0445204 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15190 (NCI Thesaurus ObjectClass)
C0936232 (UMLS 2011AA ObjectClass)

CL.8

Code List

Was a pre-operative needle biopsy performed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PreoperativeNeedleBiopsyPerformedDate

Item

Date of biopsy

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C54732 (NCI Thesaurus ObjectClass)
C0445204 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15190 (NCI Thesaurus ObjectClass)
C0936232 (UMLS 2011AA ObjectClass)

LungTumorHistologicClassificationLungTumorHistologicCategory

Item

Histology

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.9

Code List

Histology

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

Benign Mass (Benign mass)

CL Item

Carcinoid (Carcinoid)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Other (Other specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TumorHistologicCategorySpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

MedDRACode

Item

MedDRA disease code

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

Pulmonary Function Tests

Item Group

Unnamed2

LungPulmonaryFunctionDate

Item

Date of Pulmonary Function Test

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C13304 (NCI Thesaurus Property)
C2709248 (UMLS 2011AA Property)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)

LungForcedExpiratoryVolume1TestPercentageValue

Item

Forced Expiratory Volume 1 (%Predicted FEV1)

double

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property)
C0849974 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

VitalLungCapacityTestPercentageValue

Item

Forced Vital Capacity (% predicted) (FVC)

double

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ObjectClass)
C0442732 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25443 (NCI Thesaurus Property)
C1516240 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LungForcedExpiratoryVolume1TestSpecifiedValue

Item

Forced Expiratory Volume 1 (FEV1) (Observed)

double

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property)
C0849974 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)

VitalLungCapacityTestSpecifiedValue

Item

Forced Vital Capacity (FVC) (Observed)

double

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ObjectClass)
C0442732 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25443 (NCI Thesaurus Property)
C1516240 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Smoking Status

Item Group

Unnamed3

SmokingHistoryInd

Item

Smoking History

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.10

Code List

Smoking History

CL Item

Never Smoked (Never smoked)

CL Item

Currently Smoking (Currently smoking)

CL Item

Smoked In The Past (Smoked in the past)

CigaretteSmokingHistoryPackYearAmount

Item

Number pack years smoked (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)

ProtocolTreatmentArmAssignmentType

Item

Assigned Treatment Arm

text

C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.11

Code List

Assigned Treatment Arm

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Patient Not Randomized (Patient not randomized)

CL Item

Wedge Resection (Wedge resection)

PatientNoDuringSurgicalProcedureRandomizationReason

Item

Patient not randomized, specify reason

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C25490 (NCI Thesaurus Property)
C0347984 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.12

Code List

Patient not randomized, specify reason

CL Item

Benign (Benign Mass)

C14172 (NCI Thesaurus)
C0205183 (UMLS 2011AA)

CL Item

Carcinoid Tumor (Carcinoid)

C2915 (NCI Thesaurus)
C0007095 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Positive Lymph Node (Positive Nodes (pre- or intra-operatively))

C27296 (NCI Thesaurus)
C0746319 (UMLS 2011AA)

PatientNoDuringSurgicalProcedureRandomizationSpecify

Item

Other, specify

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C25490 (NCI Thesaurus Property)
C0347984 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Footer

Item Group

Footer

ResponsiblePersonName

Item

Completed by (Last name, First name)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Lung Cancer NCT00499330 On-Study - CALGB: 140503 On-Study Form - 2537927v1.0

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...

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