ID

11459

Beschrijving

ADVL0212: On Study Worksheet [reload] NCT00053963 FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B304C5F5-C7EC-0452-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B304C5F5-C7EC-0452-E034-0003BA12F5E7

Trefwoorden

C71.9

Clinical Trial

D016543

On-Study Form

Geüploaded op

5 juli 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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ADVL0212: On Study Worksheet [reload] NCT00053963

model
Details

No Instruction available.

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StudyEvent: ADVL0212: On Study Worksheet [reload]
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header

Item Group

Header

Protocol ID COG

Item

Study Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (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)

PatientCOGIdentifierNumber

Item

COG Number

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)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)

Patient Initials

Item

Patient's Initials

text

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

DataEnteredDate

Item

Date worksheet entered into RDE

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)

PatientPaymentType

Item

Method of Payment

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.1

Code List

Method of Payment

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 (including CHAMPUS and TRICARE))

CL Item

Veterans Sponsored (Veterans sponsored)

CL Item

Self Pay (no Insurance) (Self pay (no insurance))

CL Item

No Means Of Payment (no Insurance) (No means of payment (no insurance))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Treatment related information

Item Group

Treatment related information

SpecimenAccessionNumber

Item

Accession number (Pre-populated by the registration system.)

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25402 (NCI Thesaurus Property)
C1510755 (UMLS 2011AA Property)

StudyStratificationText

Item

Stratum (Pre-populated by the registration system.)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)

Protocol Treatment Arm

Item

Treatment Number (Pre-populated by the registration system.)

text

C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)

TreatingInstitutionIdentifierCode

Item

Treating Institution (Pre-populated by the registration system.)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)

TreatingPhysicianName

Item

Treating Physician (Pre-populated by the registration system.)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)

ProtocolRandomizationDate

Item

Date of Randomization (Pre-populated by the registration system.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)

PatientCallbackDate

Item

Date of call back (Pre-populated by the registration system.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)

PatientRegistrationDate

Item

Date of Registration (Pre-populated by the registration system.)

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)

Treatment Begin Date

Item

Treatment Start Date (Pre-populated by the registration system.)

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Diagnosis

Item Group

Diagnosis

Measurable Disease

Item

Does patient have measurable disease? (1. Required field)

boolean

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

BoneMarrowPre-StudyEvaluationInd-2

Item

Did patient have a bone marrow evaluation just prior to study entry? (1. Required field)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C38010 (NCI Thesaurus Property-2)
C1527048 (UMLS 2011AA Property-2)

BoneMarrowEvaluationDate

Item

what was the date of the exam? (MM/DD/YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)

BoneMarrowInvolvementInd-3

Item

does patient have bone marrow involvement? (Reset)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

RadiationTherapyBoneMarrowAdministeredInd-2

Item

Has patient had radiation therapy delivered to 20% or more of her or his bone marrow? (1. Required field <attach help text document ADVL0212 marrow help.doc>)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

ShorteningFractionEchocardiogramAssessedInd-2

Item

Was patient's shortening fraction determined by echocardiogram? (1. Required field)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)

ShorteningFractionResultPercentageValue

Item

what was the percentage? (1. Must be greater than or equal to 28%)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38020 (NCI Thesaurus ObjectClass)
C1335957 (UMLS 2011AA ObjectClass)

EjectionFractionRadionuclideVentriculogramScanAssessmentInd-2

Item

Was patient's ejection fraction determined by MUGA? (1. Required field)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property-2)
C0521317 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)

EjectionFractionResultPercentageValue

Item

what was the percentage? (1. Must be greater than or equal to 45%)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

Hemogram

Item Group

Hemogram

HematologyLabCollectedDate

Item

Test date (MM/DD/YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ValueDomain-2)

Hemoglobin

Item

Hgb (g/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Leukocytes (WBC)

Item

WBC (1. Accepted range is 0.9-50. A value of less than 0.9 or greater than 50 generates a warning on the institutional data receipt, but does not prevent data entry)

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)

Assessment Lab UOM

Item

Assessment Lab (unit of measure)

text

C20989 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
C0031809 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
C1519795 (UMLS CUI-3)

CL.13

Code List

Assessment Lab (unit of measure)

CL Item

International Units Per Liter (IU/L)

CL Item

Mu/ml (mU/mL)

HematologyPlateletLabUnspecifiedValue

Item

Platelets (1. Accepted range is 30-1500. A value of less than 30 or greater than 1500 generates a warning on the institutional data receipt, but does not prevent data entry)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureSegmentedNeutrophilOutcomePercentageValue

Item

Segs (%)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C36719 (NCI Thesaurus Property-2)
C0229640 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureNeutrophilBandFormCountResultPercentageValue

Item

Bands (%)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64830 (NCI Thesaurus Property-2)
C1882076 (UMLS 2011AA Property-2)
C49100 (NCI Thesaurus ValueDomain)
C1704610 (UMLS 2011AA ValueDomain)

TransfusionReceivedInd

Item

Was red cell transfusion given as a result of CBC? (1. Required field)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)

CL.9

Code List

Was red cell transfusion given as a result of CBC? (1. Required field)

CL Item

No Transfusion (No)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Transfusion With Platelets And Red Blood Cells (Yes, both)

CL Item

Transfusion With Platelets (Yes, platelets)

CL Item

Transfusion With Red Blood Cells (Yes, red blood cells)

Chemistries

Item Group

Chemistries

ChemistryLabCollectedDate

Item

Test date (MM/DD/YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C16414 (NCI Thesaurus ObjectClass)
C0007996 (UMLS 2011AA ObjectClass)

HepaticSGPT(ALT)LabUnspecifiedValue

Item

ALT (acceptable units: IU/L, or mU/mL)

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

ALT (institutional upper limit of normal)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HepaticSGOT(AST)LabUnspecifiedValue

Item

AST (acceptable units: IU/L, or mU/mL)

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

AST (institutional upper limit of normal)

float

C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HepaticTotalBilirubinLabSpecifiedValue

Item

T. Bilirubin (mg/dL)

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)

Bilirubin, Total ULN

Item

T. Bilirubin- institutional upper limit or normal (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)

RenalCreatinineLabSpecifiedValue

Item

Creatinine (mg/dL)

float

RenalCreatinineLabSpecifiedUpperLimitofNormalValue

Item

Creatinine- institutional upper limit of normal (mg/dL)

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
C1519815 (UMLS 2011AA ValueDomain-3)

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)

CCRR MODULE

Item Group

Ccrr Module For Advl0212: On Study Worksheet [reload]

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ADVL0212: On Study Worksheet [reload] NCT00053963

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