ID

10827

Description

NCI Cooperative Group Colorectal Cancer - Adjuvant On-Study Form (New) NCT00079274 Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DFAA558D-FB7F-67DB-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DFAA558D-FB7F-67DB-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
Uploaded on

June 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NCI Coop Group Colorectal Ca Adjuvant On-Study Form NCT00079274

English

Visit: Pre-Treatment (prior to randomization)

1 forms  
  1. StudyEvent: NCI Coop Group Colorectal Ca Adjuvant On-Study Form
    1. Visit: Pre-Treatment (prior to randomization)
Clinical trial administrative data
Description

Clinical trial administrative data

Coordinating Group Protocol Number
Description

Protocol ID Coordinating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Coordinating Group Code
Description

Coordinating Group Code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI-1
C1711341
NCI Thesaurus ObjectClass
C17005
UMLS CUI-2
C0805701
NCI Thesaurus ObjectClass-2
C25462
NCI Thesaurus Property
C25364
Protocol Title
Description

Protocol Title

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Patient Study ID
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Medical Record Number
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Patient Initials (L, FM)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Code (Cooperative Group where credit will be applied)
Description

ParticipatingGroupIdentifierCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C17005
UMLS 2011AA ObjectClass-2
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Name (treating location/performance site)
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Are data amended (If data are amended, please circle in red when using paper form)
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Colorectal: Disease Characteristics
Description

Colorectal: Disease Characteristics

Primary Site
Description

ColorectalCancerPrimarySite

Data type

text

Alias
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Was there bowel obstruction?
Description

ObstructionPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Metathesaurus ObjectClass
C0028778
Was there bowel perforation?
Description

TumorPerforationInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C4080
UMLS 2011AA Property
C0549099
Disease Extent
Description

ColorectalDiseaseExtentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C25332
UMLS 2011AA Property
C0439792
Number of Lymph Nodes Examined
Description

LymphNodeExaminedCount

Data type

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of Positive Lymph Nodes
Description

LymphNodePositiveCount

Data type

float

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Surgical Information
Description

Surgical Information

Surgery Date (date primary tumor removed; < 56 days prior to randomization)
Description

Surgery Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1628561
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus Property
C25275
Type of procedure
Description

SurgicalProcedureApproachType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25424
UMLS 2011AA Property
C0449445
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Visit: Pre-Treatment (prior to randomization)

1 forms
  1. StudyEvent: NCI Coop Group Colorectal Ca Adjuvant On-Study Form
    1. Visit: Pre-Treatment (prior to randomization)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Clinical trial administrative data
Protocol ID Coordinating Group
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Coordinating Group Code
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials (L, FM)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
ParticipatingGroupIdentifierCode
Item
Participating Group Code (Cooperative Group where credit will be applied)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Institution Name
Item
Institution Name (treating location/performance site)
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended (If data are amended, please circle in red when using paper form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Colorectal: Disease Characteristics
Item
Primary Site
text
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.2
Code List
Primary Site
CL Item
Cecum (Cecum)
C12381 (NCI Thesaurus)
C0007531 (UMLS 2011AA)
CL Item
Ascending Colon (Ascending colon)
C12265 (NCI Thesaurus)
C0227375 (UMLS 2011AA)
CL Item
Hepatic Flexure (Hepatic flexure)
C12266 (NCI Thesaurus)
C0227385 (UMLS 2011AA)
CL Item
Transverse Colon (Transverse colon)
C12385 (NCI Thesaurus)
C0227386 (UMLS 2011AA)
CL Item
Splenic Flexure (Splenic flexure)
C12267 (NCI Thesaurus)
C0227387 (UMLS 2011AA)
CL Item
Descending Colon (Descending colon)
C12268 (NCI Thesaurus)
C0227389 (UMLS 2011AA)
CL Item
Sigmoid Colon (Sigmoid colon)
C12384 (NCI Thesaurus)
C0227391 (UMLS 2011AA)
ObstructionPresentInd-3
Item
Was there bowel obstruction?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C0028778 (NCI Metathesaurus ObjectClass)
TumorPerforationInd
Item
Was there bowel perforation?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C4080 (NCI Thesaurus Property)
C0549099 (UMLS 2011AA Property)
Item
Disease Extent
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C25332 (NCI Thesaurus Property)
C0439792 (UMLS 2011AA Property)
CL.5
Code List
Disease Extent
CL Item
T1 (Tumor invades submucosa (Ta))
C1179687 (NCI Metathesaurus)
CL Item
T2 (Tumor invades muscularis propria (T2))
CL Item
T3 (Tumor invades through the muscularis propria into the subserosa, or into nonperitonealized pericolic or perirectal tissue (T3))
CL Item
T4 (Tumor directly invades or is adherent to other organs or structures and/or involves the visceral peritoneum (T4))
CL Item
Tx (Primary tumor cannot be assessed (TX))
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Surgical Information
Surgery Date
Item
Surgery Date (date primary tumor removed; < 56 days prior to randomization)
date
C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item
Type of procedure
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25424 (NCI Thesaurus Property)
C0449445 (UMLS 2011AA Property)
CL.6
Code List
Type of procedure
CL Item
Laparoscopic Surgery (Laparoscopic)
C15725 (NCI Thesaurus)
C0751429 (UMLS 2011AA)
CL Item
Laparoscopic Converted To Open (Laparoscopic converted to open)
CL Item
Laparoscopic Hand-assisted (Laparoscopic hand-assisted)
CL Item
Open (open)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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