ID

24864

Beschreibung

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

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 20.08.17 20.08.17 -
Hochgeladen am

20. August 2017

DOI

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Lizenz

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

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: COG AALL0932 OPEN Registration Worksheet
    1. No Instruction available.
Stratification
Beschreibung

Stratification

Alias
UMLS CUI-1
C1514983
AALL0932 Stratum
Beschreibung

Stratification Factors Type

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C16153
UMLS CUI [1,1]
C1514984
UMLS CUI [1,2]
C0332307
Projected Treatment Start Date of systemic chemotherapy drug/treatment delivery
Beschreibung

Chemotherapy Start Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C15632
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus Property
C25382
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C3173309
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Is the patient enrolled on study AALL08B1
Beschreibung

Enrollment

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1516879
Was the patient in the indicated age range at time of diagnosis
Beschreibung

PatientAgeEligibilityDeterminationInd-2 (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)

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
NCI Thesaurus Property-2
C25171
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0013893
Does patient have WBC in the indicated range
Beschreibung

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2 (Initial WBC is <50,000/microl. To be eligible, answer must be 'yes.')

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C12529
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25171
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0013893
Does the patient have newly diagnosed B-precursor ALL
Beschreibung

B-precursor ALL

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C3161
NCI Thesaurus Property
C15220
UMLS CUI [1,1]
C1292769
UMLS CUI [1,2]
C0011900
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1516637
Has the patient received Prior Treatment with cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously
Beschreibung

PatientChemotherapyEligibilityDeterminationInd-4 (with exception of intrathecal cytarabine [Section 3.2.4] or steroids [Section 3.3.2] for the current ALL diagnosis)

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C15632
NCI Thesaurus Property-2
C25171
NCI Thesaurus ValueDomain
C49486
UMLS CUI [1]
C0677881
Does patient have CNS 3 involvement
Beschreibung

CNS involvement

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12438
UMLS CUI [1]
C0449389
Does the patient have testicular disease
Beschreibung

testicular disease

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C12412
NCI Thesaurus Property
C25547
UMLS CUI [1]
C0039584
Regulatory Information
Beschreibung

Regulatory Information

Alias
UMLS CUI-1
C1301773
UMLS CUI-2
C1516637
Have all institutional, FDA, and NCI requirements for human studies been met?
Beschreibung

requirements

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C15206
NCI Thesaurus Property
C38015
UMLS CUI [1]
C1516637
Date Informed Consent Signed
Beschreibung

Informed Consent Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Comments Module
Beschreibung

Comments Module

Alias
UMLS CUI-1
C0947611
Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS CUI [1]
C0947611
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No Instruction available.

1 Formulare
  1. StudyEvent: COG AALL0932 OPEN Registration Worksheet
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Stratification
C1514983 (UMLS CUI-1)
Item
AALL0932 Stratum
integer
C25284 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C16153 (NCI Thesaurus Property)
C1514984 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL.1
Code List
AALL0932 Stratum
CL Item
Non-down Syndrome Patient (1)
CL Item
Down Syndrome Patient (2)
Chemotherapy Start Date
Item
Projected Treatment Start Date of systemic chemotherapy drug/treatment delivery
date
C25164 (NCI Thesaurus ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Enrollment
Item
Is the patient enrolled on study AALL08B1
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C2348568 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
age range
Item
Was the patient in the indicated age range at time of diagnosis
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C0001779 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
WBC
Item
Does patient have WBC in the indicated range
boolean
C38147 (NCI Thesaurus ValueDomain)
C12529 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0023508 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
B-precursor ALL
Item
Does the patient have newly diagnosed B-precursor ALL
boolean
C38147 (NCI Thesaurus ValueDomain)
C3161 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C1292769 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
cytotoxic chemotherapy
Item
Has the patient received Prior Treatment with cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously
boolean
C16960 (NCI Thesaurus ObjectClass)
C15632 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C49486 (NCI Thesaurus ValueDomain)
C0677881 (UMLS CUI [1])
CNS involvement
Item
Does patient have CNS 3 involvement
boolean
C38148 (NCI Thesaurus ValueDomain)
C25331 (NCI Thesaurus Property)
C12438 (NCI Thesaurus ObjectClass)
C0449389 (UMLS CUI [1])
Item
Does the patient have testicular disease
integer
C25180 (NCI Thesaurus ValueDomain)
C12412 (NCI Thesaurus ObjectClass)
C25547 (NCI Thesaurus Property)
C0039584 (UMLS CUI [1])
CL.8
Code List
Does the patient have testicular disease
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/a, Female (3)
Item Group
Regulatory Information
C1301773 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
requirements
Item
Have all institutional, FDA, and NCI requirements for human studies been met?
boolean
C38147 (NCI Thesaurus ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C38015 (NCI Thesaurus Property)
C1516637 (UMLS CUI [1])
Informed Consent Date
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Comments Module
C0947611 (UMLS CUI-1)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1])
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