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  1. StudyEvent: E3201 Surgery Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Time Period
text
Code List
Time Period
CL Item
One month post surgery (One month post surgery)
CL Item
Study entry (Study entry)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Surgery assessment
Item
Patient Group
text
C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
Patient Group
CL Item
Group I (Group I)
CL Item
Group II (Group II)
Item
Planned Surgery Type
text
Code List
Planned Surgery Type
CL Item
Low Anterior Resection (low anterior resection)
CL Item
Abdominal Perineal Resection (abdominal perineal resection)
CL Item
Low Anterior Resection/coloanal Anastomosis (low anterior resection/coloanal anastomosis)
CL Item
Other, Specify (other, specify)
other,specify(surgery)
Item
other, specify (surgery)
text
Pre-surgerytumordistancefromtheanalverge
Item
Pre-surgery tumor distance from the anal verge
text
Item
Rectal tumor status
text
Code List
Rectal tumor status
CL Item
Fixed (fixed)
CL Item
Tethered (tethered)
CL Item
Mobile (mobile)
C25295 (NCI Thesaurus)
C0231435 (UMLS 2011AA)
Didpatientundergosurgicalresection?
Item
Did patient undergo surgical resection?
boolean
Reasonsurgerynotperformed
Item
Reason surgery not performed
text
SurgeryDate
Item
Surgery date
date
ProtocolSurgery,QualifyingResultsInd
Item
Do surgery results qualify patient for further protocol therapy?
boolean
Item
Primary surgery type
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C9118 (NCI Thesaurus ObjectClass-3)
C1261473 (UMLS 2011AA ObjectClass-3)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Primary surgery type
CL Item
Low Anterior Resection (low anterior resection)
CL Item
Abdominal Perineal Resection (abdominal perineal resection)
CL Item
Low Anterior Resection/coloanal Anastomosis (low anterior resection/coloanal anastomosis)
CL Item
Other, Specify (other, specify)
PrimarySurgery,OtherType
Item
other, specify (surgery)
text
ColorectalSurgicalProcedureSphincterPreservedInd-2
Item
Was sphincter preserved?
boolean
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C28381 (NCI Thesaurus Property)
C1409894 (UMLS 2011AA Property)
C0456735 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PerforationInd
Item
Was there bowel perforation?
boolean
ObstructionInd
Item
Was there bowel obstruction?
boolean
TumorSpillageInd
Item
Was there tumor spillage?
boolean
LymphNodesRemovedInd
Item
Were all lymph nodes suggestive of disease removed?
boolean
PriorSurgicalResectionInd
Item
Was a complete resection done?
boolean
Item
Was completion of an en bloc resection of the primary tumor documented?
text
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C25733 (NCI Thesaurus ObjectClass-2)
C1516835 (UMLS 2011AA ObjectClass-2)
Code List
Was completion of an en bloc resection of the primary tumor documented?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
TumorAdherenceInd
Item
Did the primary tumor adhere to or invade an adjacent organ?
boolean
Specifyorgans
Item
Specify organs
text
LymphNode(s)ExaminedNumber
Item
Number of lymph nodes examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
Numberoflymphnodesremoved
Item
Number of lymph nodes removed
text
DistancetoDistalBowel
Item
Distance from the tumor to distal bowel
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
DistancetoProximalBowel
Item
Distance from the tumor to proximal bowel
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
RadialMarginsDiseaseFreeGrossInd
Item
Have the radial margins been documented as grossly free of disease?
boolean
RadialMarginsDiseaseFreeMicroInd
Item
Have the radial margins been documented as histologically free of disease?
boolean
Item
Type of anastomosis
text
Code List
Type of anastomosis
CL Item
End-to-end (end-to-end)
CL Item
End-to-side (end-to-side)
Wasanastomosisstapled?
Item
Was anastomosis stapled?
boolean
Wasapouchcreated?
Item
Was a pouch created?
boolean
Lengthofpouch
Item
Length of pouch
text
Item Group
Tumor Statging
Item
Pathologic T stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic T stage
CL Item
T1 (T1)
CL Item
T2 (T2)
CL Item
T3 (T3)
CL Item
T4 (T4)
Item
Pathologic N Stage
text
Code List
Pathologic N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis In 1 To 3 Regional Lymph Nodes (N1)
CL Item
Metastasis In 4 Or More Regional Lymph Nodes (N2)
CL Item
N3 (N3)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Ccrr Module For E3201 Surgery Form

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