ID

2049

Description

COG AALL0932 OPEN Registration Worksheet Risk-Adapted Chemotherapy in Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9C7D432C-9BE0-E727-E040-BB89AD430C05

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9C7D432C-9BE0-E727-E040-BB89AD430C05

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 8/20/17 8/20/17 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT01190930 Registration - COG AALL0932 OPEN Registration Worksheet - 3192487v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: COG AALL0932 OPEN Registration Worksheet
    1. No Instruction available.
Stratification
Description

Stratification

AALL0932 Stratum (Select appropriate stratum)
Description

ClinicalStudyProtocolStratificationFactorsType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C16153
UMLS 2011AA Property
C1514984
Projected Treatment Start Date of systemic chemotherapy drug/treatment delivery (MM/DD/CCYY Study enrollment must take place within five 5 days of beginning protocol therapy. If enrollment takes place before starting therapy, the date protocol therapy is projected to start must be no later than five 5 calendar days after enrollment. Do not report intrathecal IT cytarabine as start date for Induction therapy, however, systemic drug/treatment delivery must begin within 72 hours of administering this IT therapy)
Description

ChemotherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Inclusion Criteria
Description

Inclusion Criteria

Is the patient enrolled on study AALL08B1 (To be eligible, patients must be enrolled on COG AALL08B1 before treatment on AALL0932 begins with the exception of the first dose of intrathecal chemotherapy.)
Description

PatientOtherEnrollmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Was the patient in the indicated age range at time of diagnosis (Indicated age range: >365 days and <10 years of age To be eligible, patient must be >365 days and <10 years of age at time of diagnosis)
Description

PatientAgeEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Does patient have WBC in the indicated range (Initial WBC is <50,000/microl. To be eligible, answer must be 'yes.')
Description

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Does the patient have newly diagnosed B-precursor ALL (To be eligible, patient must be newly diagnosed with NCI Standard Risk B-precursor acute lymphoblastic leukemia ALL.)
Description

ALLNeuroblastomaDiagnosisInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Exclusion Criteria
Description

Exclusion Criteria

Has the patient received Prior Treatment with cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously (with exception of intrathecal cytarabine [Section 3.2.4] or steroids [Section 3.3.2] for the current ALL diagnosis)
Description

PatientChemotherapyEligibilityDeterminationInd-4

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Does patient have CNS 3 involvement (CNS status must be known prior to enrollment as patients with CNS3 involvement are not eligible for this study. See Section 3.2.4 for details)
Description

CentralNervousSystemProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12438
UMLS 2011AA ObjectClass
C0927232
Does the patient have testicular disease (Patient is not eligible if he has testicular disease)
Description

TestisInvolvedIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C12412
UMLS 2011AA ObjectClass
C0039597
NCI Thesaurus Property
C25547
Regulatory Information
Description

Regulatory Information

Have all institutional, FDA, and NCI requirements for human studies been met?
Description

StudyCompleteRequirementsInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C38015
Date Informed Consent Signed (MM/DD/CCYY Date entered is the date last authorized signature is obtained)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Comments Module
Description

Comments Module

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: COG AALL0932 OPEN Registration Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Stratification
Item
AALL0932 Stratum (Select appropriate stratum)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16153 (NCI Thesaurus Property)
C1514984 (UMLS 2011AA Property)
CL.1
Code List
AALL0932 Stratum (Select appropriate stratum)
CL Item
Non-down Syndrome Patient (Non-Down Syndrome Patient)
CL Item
Down Syndrome Patient (Down Syndrome Patient)
ChemotherapyAdministeredBeginDate
Item
Projected Treatment Start Date of systemic chemotherapy drug/treatment delivery (MM/DD/CCYY Study enrollment must take place within five 5 days of beginning protocol therapy. If enrollment takes place before starting therapy, the date protocol therapy is projected to start must be no later than five 5 calendar days after enrollment. Do not report intrathecal IT cytarabine as start date for Induction therapy, however, systemic drug/treatment delivery must begin within 72 hours of administering this IT therapy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Inclusion Criteria
Item
Is the patient enrolled on study AALL08B1 (To be eligible, patients must be enrolled on COG AALL08B1 before treatment on AALL0932 begins with the exception of the first dose of intrathecal chemotherapy.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.2
Code List
Is the patient enrolled on study AALL08B1 (To be eligible, patients must be enrolled on COG AALL08B1 before treatment on AALL0932 begins with the exception of the first dose of intrathecal chemotherapy.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was the patient in the indicated age range at time of diagnosis (Indicated age range: >365 days and <10 years of age To be eligible, patient must be >365 days and <10 years of age at time of diagnosis)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.3
Code List
Was the patient in the indicated age range at time of diagnosis (Indicated age range: >365 days and <10 years of age To be eligible, patient must be >365 days and <10 years of age at time of diagnosis)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does patient have WBC in the indicated range (Initial WBC is <50,000/microl. To be eligible, answer must be 'yes.')
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.4
Code List
Does patient have WBC in the indicated range (Initial WBC is <50,000/microl. To be eligible, answer must be 'yes.')
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have newly diagnosed B-precursor ALL (To be eligible, patient must be newly diagnosed with NCI Standard Risk B-precursor acute lymphoblastic leukemia ALL.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.5
Code List
Does the patient have newly diagnosed B-precursor ALL (To be eligible, patient must be newly diagnosed with NCI Standard Risk B-precursor acute lymphoblastic leukemia ALL.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Exclusion Criteria
Item
Has the patient received Prior Treatment with cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously (with exception of intrathecal cytarabine [Section 3.2.4] or steroids [Section 3.3.2] for the current ALL diagnosis)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.6
Code List
Has the patient received Prior Treatment with cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously (with exception of intrathecal cytarabine [Section 3.2.4] or steroids [Section 3.3.2] for the current ALL diagnosis)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Does patient have CNS 3 involvement (CNS status must be known prior to enrollment as patients with CNS3 involvement are not eligible for this study. See Section 3.2.4 for details)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
CL.7
Code List
Does patient have CNS 3 involvement (CNS status must be known prior to enrollment as patients with CNS3 involvement are not eligible for this study. See Section 3.2.4 for details)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have testicular disease (Patient is not eligible if he has testicular disease)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C12412 (NCI Thesaurus ObjectClass)
C0039597 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.8
Code List
Does the patient have testicular disease (Patient is not eligible if he has testicular disease)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a, Female (N/A, female)
Item Group
Regulatory Information
Item
Have all institutional, FDA, and NCI requirements for human studies been met?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
CL.9
Code List
Have all institutional, FDA, and NCI requirements for human studies been met?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (MM/DD/CCYY Date entered is the date last authorized signature is obtained)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item Group
Comments Module
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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