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  1. StudyEvent: ACNS0122 Eligibility Worksheet
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Institution Name
Item
Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
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)
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)
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 Name
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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)
Item Group
Eligibility Assessment
PatientRequiredAgeInd-2
Item
Was the patient greater than 3 years of age and less than 25 years of age at diagnosis?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property-2)
C0001779 (UMLS 2011AA Property-2)
DiseaseHistologicDiagnosisInd
Item
Did the patient have histologic verification of one of the following? -Endodermal sinus tumor (yolk sac tumor); -Embryonal carcinoma; -Choriocarcinoma; -Immature teratoma; -Teratoma with malignant transformation; -Mixed germ cell tumor
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
GermCellTumorEligibilityInd-2
Item
Did the patient have any histologically confirmed germ cell tumor with elevation of serum/CSF beta HCG >50 IU/dl or any elevation of CSF alpha fetoprotein >10IU/L
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
BrainTumorEligibilityInd-2
Item
Did the patient have histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF tumor markers of beta>50 IU/dl or any elevation of alpha fetoprotein >10 IU/L?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
PriorSurgeryPerformedInd-3
Item
Was surgery performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
CranialMRIPerformedInd-2
Item
was a cranial MRI with gadolinium obtained prior to induction or pre-operative and post-operative? (If yes,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
SpinalMRIPerformedInd-2
Item
No
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
SpinalMRIPerformedInd-2
Item
No
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
SpinalMRIPerformedInd-2
Item
No
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
TreatmentRequiredBeginDateInd-2
Item
Will the start of treatment begin within 31 days of initial diagnosis and within 7 days from study enrollment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Karnofsky Performance Score
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C28013 (NCI Thesaurus ObjectClass)
C0206065 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Karnofsky Performance Score
CL Item
100 (Normal, no complaints, no evidence of disease.)
CL Item
90 (Able to carry on normal activity, minor signs or symptoms of disease.)
CL Item
80 (Normal activity with effort, some signs or symptoms of disease.)
CL Item
70 (Cares for self. Unable to carry on normal activity or to do active work.)
CL Item
60 (Requires occasional assistance, but is able to care for most of own needs.)
CL Item
50 (Requires considerable assistance and frequent medical care.)
CL Item
40 (Disabled, requires special care and assistance.)
CL Item
30 (Severely disabled, hospitalization is indicated although death is not imminent.)
CL Item
20 (Hospitalization necessary, very sick, active supportive treatment necessary,)
CL Item
10 (Moribund, fatal processes progressing rapidly.)
CL Item
0 (Dead.)
C0919414 (NCI Metathesaurus)
Item
Lansky Play Score
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Lansky Play Score
CL Item
100 (Fully active, normal)
CL Item
90 (Minor restrictions in physically strenuous activity.)
CL Item
80 (Active, but tires more quickly.)
CL Item
70 (Both greater restriction of and less time spent in play activity.)
CL Item
60 (Up and around, but minimal active play; keeps busy with quieter activities.)
CL Item
50 (Gets dressed but lies around much of the day, no active play, able to participate in all quiet play and activities.)
CL Item
40 (Mostly in bed; participates in quiet activities.)
CL Item
30 (In bed; needs assistance even for quiet play.)
CL Item
20 (Often sleeping; play entirely limited to very passive activities.)
CL Item
10 (No play; does not get out of bed.)
CL Item
0 (Unresponsive.)
C0919414 (NCI Metathesaurus)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Does the patient have a life expectancy of more than or equal to 2 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Does the patient have a life expectancy of more than or equal to 2 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CancerPriorTreatmentInd-3
Item
Has patient received prior treatment other than surgery and corticosteriods?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
PriorGrowthHormoneTherapyInd-2
Item
Did patient receive growth hormone therapy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
PatientBoneMarrowFunctionRequiredInd-2
Item
Does the patient have adequate bone marrow function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientRenalFunctionRequiredInd-2
Item
Does the patient have adequate renal function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientCNSFunctionRequiredInd-2
Item
Does the patient have adequate Central Nervous System function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item
is the patient pregnant and/or breastfeeding? (If female,)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
Code List
is the patient pregnant and/or breastfeeding? (If female,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
CL Item
No, And Not Nursing (no, and not nursing)
CL Item
No, But Nursing (no, but nursing)
InformedConsentFormSignedDate
Item
Has the patient and/or their parents or legal guardians signed a written informed consent?
boolean
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
StudyCompleteRequirementsInd-2
Item
Have all institutional, FDA, and NCI requirements for human studies been met?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
Item Group
Ccrr Module For Acns0122 Eligibility Worksheet

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