ID

11054

Beschrijving

E3F05 Baseline Primary Brain Tumor Disease Evaluation Form NCT00978458 Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C1947D6-6AFF-2C82-E040-BB89AD4371C6

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C1947D6-6AFF-2C82-E040-BB89AD4371C6

Trefwoorden

C71.9

D016430

Baseline

D016543

Geüploaded op

16 juni 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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E3F05 Baseline Primary Brain Tumor Disease Evaluation Form NCT00978458

model
Details

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

1 Formulieren

StudyEvent: E3F05 Baseline Primary Brain Tumor Disease Evaluation Form
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header Module

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Clinical Trial Period

Item

Report Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Report Period

CL Item

Baseline (Baseline)

C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Protocol Number

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)

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)

Data amendment

Item Group

Data amendment

Data amended

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (s M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Section I MEASURABLE LESIONS

Item Group

Section I Measurable Lesions

DiagnosticImagingRadiologyDiseaseEvaluationPresentInd-2

Item

Does patient have radiographically visible disease

boolean

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25626 (NCI Thesaurus Property-2)
C0150312 (UMLS 2011AA Property-2)
C17059 (NCI Thesaurus Property-3)
C0034599 (UMLS 2011AA Property-3)
C2991 (NCI Thesaurus Property-4)
C0012634 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

MagneticResonanceDiagnosticImagingBaselineAssessmentDate

Item

Date of Baseline MRI

date

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C16809 (NCI Thesaurus ObjectClass-2)
C0024485 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25217 (NCI Thesaurus Property-2)
C1516048 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Measurable Disease

Item

Is measurable disease present?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)

MeasurableDiseaseEnhancingLesionPresentInd-2

Item

Is enhancing measureable disease present (if yes, complete T2/FLAIR section below and T1/Contrast section p.2)

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C1513040 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C28746 (NCI Thesaurus Property-2)
C1333400 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

MeasurableDiseaseNoncontrast-EnhancingTissuePresentInd-2

Item

Is non-enhancing measureable disease present (if yes, complete T2/FLAIR section below)

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C1513040 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C81175 (NCI Thesaurus Property-2)
C2825493 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

T2/FLAIR

Item Group

T2/FLAIR

LesionSiteNumber

Item

Lesion Number

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)

Lesion Site, Primary

Item

Site of Lesion

text

C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)

LesionAssessmentDate

Item

Date of Evaluation (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)

LesionLongestBidimensionalDimensionMeasurement

Item

Longest Bidimensional Measurements of Lesions (cm)

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
C48282 (NCI Thesaurus Property-3)
C1705052 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

LesionLongestBidimensionalDimensionPerpendicularMeasurement

Item

Longest Bidimensional Measurements of Lesions (cm)

float

LesionLongestBidimensionalDimensionProductMeasurement

Item

Product of Longest Bidimensional Measurements (cm^2)

float

InvolvedOrganLateralityType

Item

Tumor Laterality

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus ObjectClass)
C13018 (NCI Thesaurus ObjectClass-2)
C0178784 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.18

Code List

Tumor Laterality

CL Item

Right (right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

CL Item

Left (left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Bilateral (bilateral)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

BrainLesionSite

Item

Site

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12439 (NCI Thesaurus ObjectClass-2)
C0006104 (UMLS 2011AA ObjectClass-2)

CL.19

Code List

Site

CL Item

Frontal Lobe (Frontal)

C12352 (NCI Thesaurus)
C0016733 (UMLS 2011AA)

CL Item

Temporal Lobe (Temporal)

C12353 (NCI Thesaurus)
C0039485 (UMLS 2011AA)

CL Item

Parietal Lobe (Parietal)

C12354 (NCI Thesaurus)
C0030560 (UMLS 2011AA)

CL Item

Occipital Lobe (Occipital)

C12355 (NCI Thesaurus)
C0028785 (UMLS 2011AA)

CL Item

Brainstem (Brainstem)

CL Item

Basal Ganglia (Basal ganglia)

C12447 (NCI Thesaurus)
C0004781 (UMLS 2011AA)

CL Item

Multifocal (Multifocal)

C25253 (NCI Thesaurus)
C0205292 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BrainLesionSiteSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12439 (NCI Thesaurus ObjectClass-2)
C0006104 (UMLS 2011AA ObjectClass-2)

MalignantNeoplasmBrainMidlineInvolvementInd-2

Item

Does tumor cross midline

boolean

C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C81170 (NCI Thesaurus Property-2)
C0549183 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

SumLesionDiameterProductMeasurement

Item

Sum of Products of Greatest Diameters (of all enhancing measurable lesions - cm^2)

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25697 (NCI Thesaurus ObjectClass-2)
C1515051 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C40352 (NCI Thesaurus ValueDomain-2)
C1704444 (UMLS 2011AA ValueDomain-2)

T1/Contrast

Item Group

T1/Contrast

Section II NON-MEASURABLE LESIONS

Item Group

Section Ii Non-measurable Lesions

Non-Measurable Disease

Item

Is non-measurable disease present?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1334988 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)

Non-measurableDiseaseEnhancingLesionPresentInd-2

Item

Is enhancing non-measureable disease present (if yes, complete T2/FLAIR section below and T1/Contrast section p.3)

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)
C1518373 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C28746 (NCI Thesaurus Property-2)
C1333400 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Non-measurableDiseaseNoncontrast-EnhancingTissuePresentInd-2

Item

Is non-enhancing non-measureable disease present (if yes, complete T2/FLAIR section below)

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)
C1518373 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C81175 (NCI Thesaurus Property-2)
C2825493 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

T2/FLAIR Non-Measurable Lesions

Item Group

Nontarget Lesions

T1/Contrast Non-Measurable Lesions

Item Group

Nontarget Lesions

Section III

Item Group

Section Iii

CorticosteroidAdministrationInd-3

Item

Is the patient receiving corticosteroids?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

ConcomitantMedicationReceivedType

Item

Name of Medication (If yes)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)

CL.22

Code List

Name of Medication (If yes)

CL Item

Decadron (Decadron)

CL Item

Other Specify (Other)

SteroidTherapyAdministeredSpecify

Item

Other,specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Concomitant Medication Daily Dose

Item

Total Daily Dose of Agent (or Drug) (Decadron or Dexamethasone equivalent mg)

float

C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)

Agent Start Date

Item

Agent Start Date (Current Dose M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date (M D Y)

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)

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E3F05 Baseline Primary Brain Tumor Disease Evaluation Form NCT00978458

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

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