ID

9991

Description

Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer NCT00324415 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1BB34737-57FC-61F2-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1BB34737-57FC-61F2-E044-0003BA3F9857

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 3/12/15 3/12/15 - Martin Dugas
Uploaded on

March 12, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Anal Cancer NCT00324415 Response - AMC-045 Response Assessment Forms (RA1; RA2) - 2514651v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-045 Response Assessment Forms (RA1; RA2)
    1. No Instruction available.
Header
Description

Header

Visit number
Description

HospitalAdmissionOrdinalNumber

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI-1
C1549755
Target Lesions (RA1)
Description

Target Lesions (RA1)

Date of Evaluation
Description

Date of Evaluation

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C20989
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C0011008
UMLS CUI-2
C0221198
UMLS CUI-3
C0031809
mm/dd/yyyy
Are there any target lesions
Description

TargetLesionPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass-2
C25702
UMLS CUI-1
C2986546
Target Lesion Site
Description

Target Lesion Site

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25341
NCI Thesaurus Property-2
C25702
UMLS CUI-1
C1521840
UMLS CUI-2
C1515974
Method of Evaluation
Description

AssessmentMethodType

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
UMLS CUI-1
C2911685
Other Specify (Method of Evaluation)
Description

AssessmentMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
UMLS CUI-1
C2911685
Longest Diameter of Lesion
Description

LesionLongestDiameterMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25285
NCI Thesaurus Property-2
C25558
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ValueDomain-2
C25285
UMLS CUI-1
C0221198
UMLS CUI-2
C1301886
UMLS CUI-3
C1522425
cm
Sum of longest diameters of all target lesions
Description

LongestLesionSumDiameterMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C25558
NCI Thesaurus ObjectClass-2
C3824
NCI Thesaurus Property
C25285
NCI Thesaurus Property-2
C25697
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C1522425
UMLS CUI-2
C0221198
UMLS CUI-3
C1301886
UMLS CUI-4
C1515051
Nontarget Lesions
Description

Nontarget Lesions

Are there any non-target lesions?
Description

NontargetLesionPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus ObjectClass-2
C25592
NCI Thesaurus Property
C25626
UMLS CUI-1
C0221198
UMLS CUI-2
C1518389
Nontarget Lesion Site
Description

LesionNontargetSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25592
UMLS 2011AA Property
C1518389
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
Follow-up status of nontarget lesion
Description

Non-TargetLesionFollow-upStatus

Data type

integer

Alias
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus ObjectClass-2
C25592
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25365
UMLS CUI-1
C0221198
UMLS CUI-2
C1518389
UMLS CUI-3
C0449438
Response Assessment Form (ra2)
Description

Response Assessment Form (ra2)

Evaluable for response
Description

DiseaseEvaluableResponseIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus Property-2
C8503
UMLS CUI-1
C1516986
Objective Status at This Evaluation
Description

Objective Status at This Evaluation

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass
C3208
UMLS CUI-1
C0871261
UMLS CUI-2
C0024299
Is complete response first observed
Description

CompleteResponseFirstObservedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25755
NCI Thesaurus ObjectClass-2
C25250
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0677874
Complete Response (CR) First Observed Date
Description

CompleteResponseFirstObservedDate

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C25755
NCI Thesaurus ObjectClass-2
C25250
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C0677874
UMLS CUI-2
C0011008
mm/dd/yyyy
Is partial response first observed
Description

Is partial response first observed

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25755
NCI Thesaurus ObjectClass-2
C25378
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1521726
Partial Response (PR) First Observed Date
Description

PartialResponseFirstObservedDate

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C25755
NCI Thesaurus ObjectClass-2
C25378
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C1521726
UMLS CUI-2
C0011008
mm/dd/yyyy
Has the patient been diagnosed with a new progression?
Description

DiseaseNewProgressionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25586
NCI Thesaurus Property-2
C25331
NCI Thesaurus ObjectClass
C2991
UMLS CUI-1
C0242656
Progressive Disease First Observed Date
Description

ProgressionFirstObservedDate

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C0242656
UMLS CUI-2
C0011008
mm/dd/yyyy
Sites of Progression
Description

ProgressionSiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C25331
UMLS CUI-1
C0242656
UMLS CUI-2
C1515974
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

ResearchCommentsText

Data type

text

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

No Instruction available.

1 forms
  1. StudyEvent: AMC-045 Response Assessment Forms (RA1; RA2)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Visit number
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI-1)
Item Group
Target Lesions (RA1)
LesionAssessmentDate
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Target lesion present
Item
Are there any target lesions
boolean
C38147 (NCI Thesaurus ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C25702 (NCI Thesaurus ObjectClass-2)
C2986546 (UMLS CUI-1)
Target Lesion Site
Item
Target Lesion Site
text
C13717 (NCI Thesaurus ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS CUI-1)
C1515974 (UMLS CUI-2)
Item
Method of Evaluation
integer
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
CL.4
Code List
Method of Evaluation
CL Item
CT Scan (1)
C0040405 (UMLS CUI-1)
CL Item
Physical exam (2)
C0031809 (UMLS CUI-1)
CL Item
Palpation (3)
C0030247 (UMLS CUI-1)
CL Item
Biopsy (4)
C0005558 (UMLS CUI-1)
CL Item
MRI scan (5)
C0917711 (UMLS CUI-1)
CL Item
PET scan (6)
C0032743 (UMLS CUI-1)
CL Item
PET/CT scan (7)
C1699633 (UMLS CUI-1)
CL Item
X-ray (8)
C0043309 (UMLS CUI-1)
CL Item
Ultrasound (9)
C0041618 (UMLS CUI-1)
CL Item
Gallium scan (10)
C0521316 (UMLS CUI-1)
CL Item
Bone scan (11)
C0203668 (UMLS CUI-1)
CL Item
other (12)
C0205394 (UMLS CUI-1)
Method of Evaluation, other
Item
Other Specify (Method of Evaluation)
text
C25685 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
Longest Diameter of Lesion
Item
Longest Diameter of Lesion
float
C3824 (NCI Thesaurus ObjectClass)
C25285 (NCI Thesaurus Property)
C25558 (NCI Thesaurus Property-2)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
C0221198 (UMLS CUI-1)
C1301886 (UMLS CUI-2)
C1522425 (UMLS CUI-3)
Sum of longest diameters of all target lesions
Item
Sum of longest diameters of all target lesions
float
C25558 (NCI Thesaurus ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C25285 (NCI Thesaurus Property)
C25697 (NCI Thesaurus Property-2)
C25209 (NCI Thesaurus ValueDomain)
C1522425 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C1301886 (UMLS CUI-3)
C1515051 (UMLS CUI-4)
Item Group
Nontarget Lesions
Nontarget lesions
Item
Are there any non-target lesions?
boolean
C38147 (NCI Thesaurus ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0221198 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
LesionNontargetSite
Item
Nontarget Lesion Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
Item
Follow-up status of nontarget lesion
integer
C3824 (NCI Thesaurus ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
C0221198 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
CL.5
Code List
Follow-up status of nontarget lesion
CL Item
Complete response (1)
C0677874 (UMLS CUI-1)
CL Item
Stable Disease (2)
C0677946 (UMLS CUI-1)
CL Item
Progressive disease (3)
C1335499 (UMLS CUI-1)
Item Group
Response Assessment Form (ra2)
Evaluable for response
Item
Evaluable for response
boolean
C25180 (NCI Thesaurus ValueDomain)
C25755 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C8503 (NCI Thesaurus Property-2)
C1516986 (UMLS CUI-1)
Item
Objective Status at This Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C25755 (NCI Thesaurus Property)
C3208 (NCI Thesaurus ObjectClass)
C0871261 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
CL.7
Code List
Objective Status at This Evaluation
CL Item
Complete Response (complete response)
CL Item
Partial Response (partial response)
C18212 (NCI Thesaurus)
CL Item
Progressive Disease (progressive disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Stable Disease (stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Unevaluable (unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Complete response
Item
Is complete response first observed
boolean
C25755 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C0677874 (UMLS CUI-1)
CR date
Item
Complete Response (CR) First Observed Date
date
C25755 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C0677874 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Partial Response
Item
Is partial response first observed
boolean
C25755 (NCI Thesaurus ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1521726 (UMLS CUI-1)
Partial Response
Item
Partial Response (PR) First Observed Date
date
C25755 (NCI Thesaurus ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1521726 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Progression
Item
Has the patient been diagnosed with a new progression?
boolean
C38147 (NCI Thesaurus ValueDomain)
C25586 (NCI Thesaurus Property)
C25331 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0242656 (UMLS CUI-1)
Progression date
Item
Progressive Disease First Observed Date
date
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C0242656 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Progression site
Item
Sites of Progression
text
C25704 (NCI Thesaurus ValueDomain)
C25341 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)
C0242656 (UMLS CUI-1)
C1515974 (UMLS CUI-2)
Item Group
Comments
C0947611 (UMLS CUI-1)
Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)
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