ID

6251

Description

COG AALL08B1 OPEN Registration Worksheet Step 2 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
Uploaded on

December 18, 2014

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

COG AALL08B1 OPEN Registration Worksheet Step 2 - 3371785v1.0

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Stratification
Description

Stratification

AALL08B1 Stratum (Select appropriate stratum)
Description

ClinicalStudyProtocolStratificationFactorsType

Data type

text

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

AALL08B1 Treatment
Description

TreatmentAssignmentType

Data type

text

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

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

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

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

Does the patient have testicular disease (Patient is not eligible if he has testicular disease)
Description

TestisInvolvedIndicator

Data type

text

Regulatory Information
Description

Regulatory Information

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

StudyCompleteRequirementsInd-2

Data type

text

Date Informed Consent Signed (MM/DD/CCYY Date entered is the date last authorized signature is obtained)
Description

InformedConsentFormSignedDate

Data type

date

Comments Module
Description

Comments Module

Comments
Description

ResearchCommentsText

Data type

text

Similar models

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Stratification
Item
AALL08B1 Stratum (Select appropriate stratum)
text
Code List
AALL08B1 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
Item
AALL08B1 Treatment
text
Code List
AALL08B1 Treatment
CL Item
Induction Therapy - Weeks 1 - 5 (Induction)
CL Item
Arm A: Post Induction Therapy For Mll-g (sr (Arm A: Post Induction)
CL Item
Arm B: Post Induction Therapy Without Lestaurtinib For Mll-r (ir/hr) (Arm B: Post Induction)
CL Item
Arm C: Post Induction Therapy With Lestaurtinib For Mll-r (ir/hr) (Arm C: Post Induction)
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
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)
CL Item
No (No)
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
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)
CL Item
No (No)
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
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)
CL Item
Yes (Yes)
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
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)
CL Item
No (No)
Item
Does the patient have testicular disease (Patient is not eligible if he has testicular disease)
text
Code List
Does the patient have testicular disease (Patient is not eligible if he has testicular disease)
CL Item
Yes (Yes)
CL Item
No (No)
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
Code List
Have all institutional, FDA, and NCI requirements for human studies been met?
CL Item
No (No)
CL Item
Yes (Yes)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (MM/DD/CCYY Date entered is the date last authorized signature is obtained)
date
Item Group
Comments Module
ResearchCommentsText
Item
Comments
text

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial