ID

7695

Beskrivning

E3201 Surgery Form Comparison of Adjuvant Chemotherapy Regimens in Treating Patients With Stage II or Stage III Rectal Cancer Who Are Receiving Radiation Therapy and Fluorouracil Before or After Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5522261-773C-6D97-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5522261-773C-6D97-E034-0003BA12F5E7

Nyckelord

  1. 2012-08-27 2012-08-27 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-06-16 2015-06-16 -
Uppladdad den

9 januari 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Colorectal Cancer NCT00068692 Treatment - E3201 Surgery Form - 2079376v3.0

No Instruction available.

  1. StudyEvent: E3201 Surgery Form
    1. No Instruction available.
Header
Beskrivning

Header

Registration Step
Beskrivning

Registration Number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Time Period
Beskrivning

TimePeriod

Datatyp

text

Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beskrivning

Patient ID ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beskrivning

Patient ID ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol No.
Beskrivning

Study Number Participating Group

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beskrivning

Trial subject ID Participating Group

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Beskrivning

Institution Name

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Unnamed2
Beskrivning

Unnamed2

Are data amended? (If yes, please circle amended items in red)
Beskrivning

Data amended

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed3
Beskrivning

Unnamed3

Patient Group
Beskrivning

Protocol Treatment Arm

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus ObjectClass
C15368
Planned Surgery Type
Beskrivning

PlannedSurgeryType

Datatyp

text

other, specify (surgery)
Beskrivning

other,specify(surgery)

Datatyp

text

Pre-surgery tumor distance from the anal verge
Beskrivning

Pre-surgerytumordistancefromtheanalverge

Datatyp

text

Rectal tumor status
Beskrivning

Rectaltumorstatus

Datatyp

text

Did patient undergo surgical resection?
Beskrivning

Didpatientundergosurgicalresection?

Datatyp

boolean

Reason surgery not performed
Beskrivning

Reasonsurgerynotperformed

Datatyp

text

Surgery date
Beskrivning

SurgeryDate

Datatyp

date

Do surgery results qualify patient for further protocol therapy?
Beskrivning

ProtocolSurgery,QualifyingResultsInd

Datatyp

boolean

Primary surgery type
Beskrivning

SarcomaPrimarySurgicalProcedurePerformedType

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus ObjectClass-3
C9118
UMLS 2011AA ObjectClass-3
C1261473
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
other, specify (surgery)
Beskrivning

PrimarySurgery,OtherType

Datatyp

text

Was sphincter preserved?
Beskrivning

ColorectalSurgicalProcedureSphincterPreservedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C28381
UMLS 2011AA Property
C1409894
NCI Metathesaurus Property
C0456735
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was there bowel perforation?
Beskrivning

PerforationInd

Datatyp

boolean

Was there bowel obstruction?
Beskrivning

ObstructionInd

Datatyp

boolean

Was there tumor spillage?
Beskrivning

TumorSpillageInd

Datatyp

boolean

Were all lymph nodes suggestive of disease removed?
Beskrivning

LymphNodesRemovedInd

Datatyp

boolean

Was a complete resection done?
Beskrivning

PriorSurgicalResectionInd

Datatyp

boolean

Was completion of an en bloc resection of the primary tumor documented?
Beskrivning

EnBlocResectionInd

Datatyp

text

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15232
UMLS 2011AA ObjectClass
C0728940
NCI Thesaurus ObjectClass-2
C25733
UMLS 2011AA ObjectClass-2
C1516835
Did the primary tumor adhere to or invade an adjacent organ?
Beskrivning

TumorAdherenceInd

Datatyp

boolean

Specify organs
Beskrivning

Specifyorgans

Datatyp

text

Number of lymph nodes examined
Beskrivning

LymphNode(s)ExaminedNumber

Datatyp

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Number of lymph nodes removed
Beskrivning

Numberoflymphnodesremoved

Datatyp

text

Distance from the tumor to distal bowel
Beskrivning

DistancetoDistalBowel

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Distance from the tumor to proximal bowel
Beskrivning

DistancetoProximalBowel

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Have the radial margins been documented as grossly free of disease?
Beskrivning

RadialMarginsDiseaseFreeGrossInd

Datatyp

boolean

Have the radial margins been documented as histologically free of disease?
Beskrivning

RadialMarginsDiseaseFreeMicroInd

Datatyp

boolean

Type of anastomosis
Beskrivning

Typeofanastomosis

Datatyp

text

Was anastomosis stapled?
Beskrivning

Wasanastomosisstapled?

Datatyp

boolean

Was a pouch created?
Beskrivning

Wasapouchcreated?

Datatyp

boolean

Length of pouch
Beskrivning

Lengthofpouch

Datatyp

text

Pathologic T stage
Beskrivning

ColorectalTumorPathologicTStage

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage
Beskrivning

NStage,Pathologic

Datatyp

text

Pathologic M Stage
Beskrivning

ColorectalTumorPathologicMStage

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Comments
Beskrivning

Research Comments

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Beskrivning

InvestigatorSignature

Datatyp

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Ccrr Module For E3201 Surgery Form
Beskrivning

Ccrr Module For E3201 Surgery Form

Similar models

No Instruction available.

  1. StudyEvent: E3201 Surgery Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
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)
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)
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)
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)
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)
Item Group
Unnamed2
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
Unnamed3
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
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)
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

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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