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  1. StudyEvent: N107C Randomization (Step 2) Form and Eligibility Checklist
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pre-treatment Requirements
C0013893 (UMLS CUI-1)
Unresected lesions
Item
Maximum 3 unresected lesions, below 3 cm
boolean
C16960 (NCI Thesaurus ObjectClass)
C12439 (NCI Thesaurus Property)
C19151 (NCI Thesaurus Property-2)
C16112 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0221198 (UMLS CUI [1,1])
C2986425 (UMLS CUI [1,2])
resection cavity
Item
resection cavity below 5.0 cm
boolean
C16960 (NCI Thesaurus ObjectClass)
C3824 (NCI Thesaurus Property)
C12439 (NCI Thesaurus Property-2)
C25654 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1515091 (UMLS CUI [1])
Item
no pregnancy
integer
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0232973 (UMLS CUI [1])
CL.3
Code List
no pregnancy
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
CL Item
No (2)
C1298908 (UMLS CUI-1)
CL Item
N/A (3)
C1272460 (UMLS CUI-1)
Negative Pregnancy Test Date
Item
Negative urine or serum pregnancy test date
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0427780 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Registration Check
C1514821 (UMLS CUI-1)
supervision of CTSU or NCCTG physician
Item
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU or NCCTG member physician
boolean
C38147 (NCI Thesaurus ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass-2)
C4035957 (UMLS CUI [1,1])
C1518419 (UMLS CUI [1,2])
Begin Therapy Post Randomization
Item
Treatment cannot begin prior to randomization and must begin <=21 days after randomization
boolean
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ObjectClass-2)
C25196 (NCI Thesaurus Property)
C38008 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C3173309 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Patient Prior Registration Laboratory Procedure Verification
Item
Tests/procedures must be completed after pre-registration, but prior to randomization
boolean
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C45513 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
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)
C2985782 (UMLS CUI [1])
Laboratory Procedure Begin Date Prior Registration
Item
Earliest test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C1115465 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Laboratory Procedure End Date Prior Registration
Item
Labtest test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0806020 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item Group
Stratification Factors
C1514984 (UMLS CUI-1)
Item
Age
text
C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C25646 (NCI Thesaurus Property-2)
C25509 (NCI Thesaurus Property-3)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0001779 (UMLS CUI [1])
CL.7
Code List
Age
CL Item
60 Years Of Age (60)
CL Item
60=>=60 Years Of Age ()
Item
Number of Preoperative Brain Metastases
text
C16960 (NCI Thesaurus ObjectClass)
C19151 (NCI Thesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C25689 (NCI Thesaurus Property-2)
C0220650 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
CL.8
Code List
Number of Preoperative Brain Metastases
CL Item
1 (1)
CL Item
2 To 4 Metastases (2 to 4)
Item
Resection cavity maximal diameter
text
C12439 (NCI Thesaurus ObjectClass)
C20051 (NCI Thesaurus ObjectClass-2)
C25285 (NCI Thesaurus Property)
C25564 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C1515091 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205289 (UMLS CUI [1,3])
CL.9
Code List
Resection cavity maximal diameter
CL Item
Resection Cavity Maximal Diameter <=3 Cm ()
CL Item
Resection Cavity Maximal Diameter >3 Cm (3 cm)
Item
Extracranial disease controlled
text
C25190 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C94424 (NCI Thesaurus Property)
C82500 (NCI Thesaurus Property-2)
C2911690 (UMLS CUI [1,1])
C0580586 (UMLS CUI [1,2])
CL.10
Code List
Extracranial disease controlled
CL Item
Extracranial Disease Controlled up to 3 Months (0-3)
CL Item
Extracranial Disease Controlled over 3 Months (3)
Item
Histology
integer
C3262 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25696 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0019638 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
CL.11
Code List
Histology
CL Item
Lung (1)
C0024109 (UMLS CUI-1)
CL Item
Radioresistant (2)
C3890377 (UMLS CUI-1)
CL Item
Other (3)
C0205394 (UMLS CUI-1)
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