ID

7962

Description

CALGB 80702 On-Study Form Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7ADB9225-BFE2-FA4C-E040-BB89AD4369EB

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7ADB9225-BFE2-FA4C-E040-BB89AD4369EB

Keywords

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

January 9, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Colorectal Cancer NCT01150045 On-Study - CALGB 80702 On-Study Form - 2970013v1.0

English

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form

1 forms  
Header
Description

Header

CALGB Form
Description

Form ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Description

Protocol ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Are data amended
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Description

Unnamed2

Patient Initials (Last, First, Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
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
Institution/Affiliate
Description

Institution Name

Data type

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
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

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
Description

Trial subject ID Participating Group

Data type

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
Patient Description
Description

Patient Description

Date of original diagnosis of colon cancer (MM DD YYYY)
Description

ColorectalCancerOriginalDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Metathesaurus ObjectClass
C0009402
MedDRA Code (disease)
Description

Primary Site MedDRA Code

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass-2
C71886
UMLS CUI-2
C1552878
NCI Thesaurus Property
C25162
NCI Thesaurus Property-2
C43820
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus ValueDomain-2
C41331
NCI Thesaurus ValueDomain-3
C45255
NCI Thesaurus ValueDomain-4
C43820
NCI Thesaurus ValueDomain-5
C25714
Has the patient had any prior cancer diagnosed? (other than colon)
Description

PriorCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Type of Prior Cancer (If Yes,)
Description

PriorCancerTypeText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Prior Cancer Diagnosis Date (year YYYY)
Description

PriorCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Clinical T Stage (TMN Stage prior to surgery Mark one with an X.)
Description

ColorectalTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus ValueDomain-2
C39315
UMLS 2011AA ValueDomain-2
C1515946
Clinical N Stage (TMN Stage prior to surgery Mark one with an X.)
Description

ColorectalTumorClinicalNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus ValueDomain-2
C39315
UMLS 2011AA ValueDomain-2
C1515946
Clinical M Stage (TMN Stage prior to surgery Mark one with an X.)
Description

ColorectalTumorClinicalMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus ValueDomain-2
C39315
UMLS 2011AA ValueDomain-2
C1515946
Tnm Stage/surgical Data
Description

Tnm Stage/surgical Data

Date of surgical resection (MM DD YYYY)
Description

PatientSurgicalResectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25698
NCI Thesaurus Property-2
C15232
UMLS 2011AA Property
C0728940
Number of positive 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
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
Lab Data At Protocol Entry
Description

Lab Data At Protocol Entry

WBC (x10^3 microL)
Description

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
ANC (x10^3 microL)
Description

Neutrophil count

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0200633
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25712
Granulocytes (%)
Description

LaboratoryProcedureGranulocyteResultPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Platelet count (x10^3 microL)
Description

Platelets

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Creatinine (mg/dL)
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Creatinine ULN (mg/dL)
Description

Creatinine, serum ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Bilirubin (mg/dL)
Description

LaboratoryProcedureTotalBilirubinResultValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Bilirubin ULN (mg/dL)
Description

Bilirubin, Total ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Cardiac Risk Factors
Description

Cardiac Risk Factors

Uncontrolled high blood pressure (systolic blood pressure >150)
Description

UncontrolledHypertensionPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
NCI Thesaurus ObjectClass-2
C48932
UMLS 2011AA ObjectClass-2
C0205318
Unstable angina
Description

UnstableAnginaDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25594
UMLS 2011AA ObjectClass
C1518422
NCI Thesaurus ObjectClass-2
C30103
UMLS 2011AA ObjectClass-2
C0205360
NCI Thesaurus ObjectClass-3
C2991
UMLS 2011AA ObjectClass-3
C0012634
NCI Thesaurus ObjectClass-4
C51221
UMLS 2011AA ObjectClass-4
C0002962
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Symptomatic congestive heart failure
Description

SymptomaticCongestiveHeartFailurePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3080
UMLS 2011AA ObjectClass
C0018802
NCI Thesaurus ObjectClass-2
C25269
UMLS 2011AA ObjectClass-2
C0231220
History of documented myocardial infarction or cerebrovascular accident
Description

PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27996
UMLS 2011AA Property
C0027051
NCI Thesaurus Property-2
C3390
UMLS 2011AA Property-2
C0038454
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
New York Heart Association Class III or IV heart failure
Description

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C7922
UMLS 2011AA Property-2
C0278962
Neurosensory or neuromotor toxicity >= grade 2
Description

NeuropathyAdverseEventToxicityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C27990
UMLS 2011AA Property
C0600688
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
History of upper gastrointestinal ulceration, bleeding or perforation within the past 3 yrs
Description

UpperGIHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ObjectClass
C17639
UMLS 2011AA ObjectClass
C0203057
Ongoing treatment with aspirin or NSAIDS including celecoxib (except low-dose aspirin < 100mg/day)
Description

CurrentMedicationNonsteroidalAntiinflammatoryDrugAspirinUseInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25471
UMLS 2011AA ObjectClass
C0521116
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C287
UMLS 2011AA Property
C0004057
NCI Thesaurus Property-2
C257
UMLS 2011AA Property-2
C0003211
NCI Thesaurus Property-3
C25340
UMLS 2011AA Property-3
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
In the past five years prior to the diagnosis of colon cancer, was the patient a regular user of any NSAIDS, aspirin or celecoxib (Regular use is defined as at least two tablets per week, on average for more than 9 months of the year. Please ask the patient this question at time of study entry.)
Description

PriorMedicationRegularNonsteroidalAntiinflammatoryDrugAspirinUseInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C287
UMLS 2011AA Property
C0004057
NCI Thesaurus Property-2
C257
UMLS 2011AA Property-2
C0003211
NCI Thesaurus Property-3
C25340
UMLS 2011AA Property-3
C0457083
NCI Thesaurus Property-4
C25647
UMLS 2011AA Property-4
C0205272
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Footer Module
Description

Footer Module

Completed by (Last name, First name)
Description

Responsible Person Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date Form Completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Back to the top of the page

Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials (Last, First, Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study 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)
Item Group
Patient Description
ColorectalCancerOriginalDiagnosisDate
Item
Date of original diagnosis of colon cancer (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C0009402 (NCI Metathesaurus ObjectClass)
Primary Site MedDRA Code
Item
MedDRA Code (disease)
float
C41331 (NCI Thesaurus ObjectClass)
C0449695 (UMLS CUI-1)
C71886 (NCI Thesaurus ObjectClass-2)
C1552878 (UMLS CUI-2)
C25162 (NCI Thesaurus Property)
C43820 (NCI Thesaurus Property-2)
C25162 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C45255 (NCI Thesaurus ValueDomain-3)
C43820 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
PriorCancerDiagnosisInd-3
Item
Has the patient had any prior cancer diagnosed? (other than colon)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PriorCancerTypeText
Item
Type of Prior Cancer (If Yes,)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
PriorCancerDiagnosisDate
Item
Prior Cancer Diagnosis Date (year YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item
Clinical T Stage (TMN Stage prior to surgery Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain-2)
C1515946 (UMLS 2011AA ValueDomain-2)
CL.3
Code List
Clinical T Stage (TMN Stage prior to surgery Mark one with an X.)
CL Item
Tumor Invades Submucosa (T1)
CL Item
Tumor Invades Muscularis Propria (T2)
CL Item
Tumor Invades Through The Muscularis Propria Into Pericolorectal Tissues (T3)
CL Item
Tumor Penetrates To The Surface Of The Visceral Peritoneum (T4a)
CL Item
Tumor Directly Invades Or Is Adherent To Other Organs Or Structures (T4b)
Item
Clinical N Stage (TMN Stage prior to surgery Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain-2)
C1515946 (UMLS 2011AA ValueDomain-2)
CL.4
Code List
Clinical N Stage (TMN Stage prior to surgery Mark one with an X.)
CL Item
Metastasis In 1 To 3 Regional Lymph Nodes (N1)
CL Item
Metastasis In 4 Or More Regional Lymph Nodes (N2)
Item
Clinical M Stage (TMN Stage prior to surgery Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain-2)
C1515946 (UMLS 2011AA ValueDomain-2)
CL.5
Code List
Clinical M Stage (TMN Stage prior to surgery Mark one with an X.)
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
Item Group
Tnm Stage/surgical Data
PatientSurgicalResectionDate
Item
Date of surgical resection (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property)
LymphNodePositiveCount
Item
Number of positive 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)
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)
Item Group
Lab Data At Protocol Entry
LaboratoryProcedureLeukocyteResultUnspecifiedValue
Item
WBC (x10^3 microL)
float
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Neutrophil count
Item
ANC (x10^3 microL)
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureGranulocyteResultPercentageValue
Item
Granulocytes (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Platelet count (x10^3 microL)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Creatinine, Serum
Item
Creatinine (mg/dL)
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, serum ULN
Item
Creatinine ULN (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (mg/dL)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Bilirubin, Total ULN
Item
Bilirubin ULN (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Item Group
Cardiac Risk Factors
UncontrolledHypertensionPresentInd-3
Item
Uncontrolled high blood pressure (systolic blood pressure >150)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C48932 (NCI Thesaurus ObjectClass-2)
C0205318 (UMLS 2011AA ObjectClass-2)
UnstableAnginaDiseasePresentInd-3
Item
Unstable angina
boolean
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C30103 (NCI Thesaurus ObjectClass-2)
C0205360 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C51221 (NCI Thesaurus ObjectClass-4)
C0002962 (UMLS 2011AA ObjectClass-4)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
SymptomaticCongestiveHeartFailurePresentInd-3
Item
Symptomatic congestive heart failure
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus ObjectClass-2)
C0231220 (UMLS 2011AA ObjectClass-2)
PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-3
Item
History of documented myocardial infarction or cerebrovascular accident
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property-2)
C0038454 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2
Item
New York Heart Association Class III or IV heart failure
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C7922 (NCI Thesaurus Property-2)
C0278962 (UMLS 2011AA Property-2)
NeuropathyAdverseEventToxicityInd-2
Item
Neurosensory or neuromotor toxicity >= grade 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
UpperGIHistoryInd-2
Item
History of upper gastrointestinal ulceration, bleeding or perforation within the past 3 yrs
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C17639 (NCI Thesaurus ObjectClass)
C0203057 (UMLS 2011AA ObjectClass)
CurrentMedicationNonsteroidalAntiinflammatoryDrugAspirinUseInd-2
Item
Ongoing treatment with aspirin or NSAIDS including celecoxib (except low-dose aspirin < 100mg/day)
boolean
C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C287 (NCI Thesaurus Property)
C0004057 (UMLS 2011AA Property)
C257 (NCI Thesaurus Property-2)
C0003211 (UMLS 2011AA Property-2)
C25340 (NCI Thesaurus Property-3)
C0457083 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorMedicationRegularNonsteroidalAntiinflammatoryDrugAspirinUseInd-2
Item
In the past five years prior to the diagnosis of colon cancer, was the patient a regular user of any NSAIDS, aspirin or celecoxib (Regular use is defined as at least two tablets per week, on average for more than 9 months of the year. Please ask the patient this question at time of study entry.)
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C287 (NCI Thesaurus Property)
C0004057 (UMLS 2011AA Property)
C257 (NCI Thesaurus Property-2)
C0003211 (UMLS 2011AA Property-2)
C25340 (NCI Thesaurus Property-3)
C0457083 (UMLS 2011AA Property-3)
C25647 (NCI Thesaurus Property-4)
C0205272 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
Responsible Person Signature
Item
Completed by (Last name, First name)
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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