ID

43502

Description

Z1041: Tumor Measurement Report (TMR) NCT00513292 Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=214B3C72-1BE1-3F2B-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=214B3C72-1BE1-3F2B-E044-0003BA3F9857

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/21/15 6/21/15 -
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Z1041: Tumor Measurement Report (TMR) NCT00513292

English

No Instruction available.

1 forms  
  1. StudyEvent: Z1041: Tumor Measurement Report (TMR)
    1. No Instruction available.
Header Module
Description

Header Module

Visit
Description

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Date
Description

PatientNotScheduleVisitDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25211
UMLS 2011AA Property-2
C0086960
NCI Thesaurus Property-3
C25716
UMLS 2011AA Property-3
C0545082
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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 Initials
Description

Patient Initials

Data type

text

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

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution Name
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
Header
Description

Header

Was a tumor assessment performed at this visit (for target lesions?)
Description

MalignantNeoplasmAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
Date of Evaluation
Description

LesionAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Lesion Number
Description

LesionSiteNumber

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
Organ
Description

LesionTargetLocationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25702
UMLS 2011AA Property-2
C1521840
Target Lesion Site (Describe specific location)
Description

LesionTargetSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25702
UMLS 2011AA Property-2
C1521840
Longest Diameter of Lesion(s) (cm)
Description

Longest Diameter of Lesion

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
UMLS CUI-1
C0221198
NCI Thesaurus Property
C25285
UMLS CUI-2
C1301886
NCI Thesaurus Property-2
C25558
UMLS CUI-3
C1522425
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ValueDomain-2
C25285
cm
Header
Description

Header

TARGET LESIONS
Description

TARGET LESIONS

Sum of Longest Diameters of All Target Lesions (Sum of both breast and axilla target lesions - cm)
Description

LongestLesionSumDiameterMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C25558
UMLS 2011AA ObjectClass
C1522425
NCI Thesaurus ObjectClass-2
C3824
UMLS 2011AA ObjectClass-2
C0221198
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25697
UMLS 2011AA Property-2
C1515051
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Baseline sum of the longest diameter (cm)
Description

BaselineMalignantNeoplasmLongestDiameterSumMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25697
UMLS 2011AA ValueDomain-2
C1515051
Percent change ([Current - Baseline/Baseline] X 100)
Description

BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25446
UMLS 2011AA Property-3
C0392747
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Percent change
Description

BaselineMalignantNeoplasmChangeLongestDiameterType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25446
UMLS 2011AA Property-3
C0392747
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Smallest previous sum of the longest diameter (cm)
Description

MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25627
UMLS 2011AA Property-3
C0205156
NCI Thesaurus Property-4
C61422
UMLS 2011AA Property-4
C0547044
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25697
UMLS 2011AA ValueDomain-2
C1515051
Percent change ([Current - Smallest previous sum/Smallest previous sum] X 100)
Description

MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25627
UMLS 2011AA Property-3
C0205156
NCI Thesaurus Property-4
C25446
UMLS 2011AA Property-4
C0392747
NCI Thesaurus Property-5
C61422
UMLS 2011AA Property-5
C0547044
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Percent change
Description

MalignantNeoplasmChangeLesserPreviousLongestDiameterType

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25627
UMLS 2011AA Property-3
C0205156
NCI Thesaurus Property-4
C25446
UMLS 2011AA Property-4
C0392747
NCI Thesaurus Property-5
C61422
UMLS 2011AA Property-5
C0547044
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Non-target Lesions
Description

Non-target Lesions

Was an assessment performed for non-target lesions at this visit?
Description

NontargetLesionFollow-upAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Are there any nontarget lesions?
Description

NontargetLesionPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
Organ
Description

LesionNontargetLocationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
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
Nontarget Lesion Site (Describe specific location)
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
Method of Evaluation
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Lesion status
Description

DiseaseResponseSiteStatus

Data type

text

Alias
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Was the non-target lesion identified on the baseline evaluation
Description

NontargetLesionBaselinePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient been diagnosed with a distant metastatic progression that has not been previously reported
Description

DistantMetastasisProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass-2
C19151
UMLS 2011AA ObjectClass-2
C0027627
Follow-up Status Of Target Lesions
Description

Follow-up Status Of Target Lesions

Target Lesion Response Status
Description

TargetLesionNegationEvaluationPerformedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25702
UMLS 2011AA ObjectClass-2
C1521840
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-3
C0884358
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Target Lesion Response Status
Description

TargetLesionResponseStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass-2
C25702
UMLS 2011AA ObjectClass-2
C1521840
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Non-Target Lesion Response Status
Description

Non-TargetLesionNegationEvaluationPerformedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-3
C0884358
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Non-Target Lesion Response Status
Description

Non-TargetLesionResponseStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Overall Response
Description

OverallLesionNegationEvaluationPerformedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25605
UMLS 2011AA ObjectClass-2
C1561607
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-3
C0884358
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Overall Response Status at This Assessment
Description

OverallTumorResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25605
UMLS 2011AA ObjectClass-2
C1561607
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Footer
Description

Footer

Completed by
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
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
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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1 forms
  1. StudyEvent: Z1041: Tumor Measurement Report (TMR)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Visit
CL Item
C1d21 (C1D21)
CL Item
C2d21 (C2D21)
CL Item
C3d21 (C3D21)
CL Item
C4d21 (C4D21)
CL Item
C5d21 (C5D21)
CL Item
C6d21 (C6D21)
CL Item
C7d21 (C7D21)
CL Item
C8d21 (C8D21)
CL Item
Unscheduled (Unscheduled)
PatientNotScheduleVisitDate
Item
Date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25211 (NCI Thesaurus Property-2)
C0086960 (UMLS 2011AA Property-2)
C25716 (NCI Thesaurus Property-3)
C0545082 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Item Group
Header
MalignantNeoplasmAssessmentInd-2
Item
Was a tumor assessment performed at this visit (for target lesions?)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
LesionAssessmentDate
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
LesionSiteNumber
Item
Lesion Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Item
Organ
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
CL.4
Code List
Organ
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
LesionTargetSite
Item
Target Lesion Site (Describe specific location)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
Longest Diameter of Lesion
Item
Longest Diameter of Lesion(s) (cm)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS CUI-1)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS CUI-2)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS CUI-3)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
Item Group
Header
Item Group
TARGET LESIONS
LongestLesionSumDiameterMeasurement
Item
Sum of Longest Diameters of All Target Lesions (Sum of both breast and axilla target lesions - cm)
float
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
BaselineMalignantNeoplasmLongestDiameterSumMeasurement
Item
Baseline sum of the longest diameter (cm)
float
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25697 (NCI Thesaurus ValueDomain-2)
C1515051 (UMLS 2011AA ValueDomain-2)
BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue
Item
Percent change ([Current - Baseline/Baseline] X 100)
float
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25446 (NCI Thesaurus Property-3)
C0392747 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Percent change
text
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25446 (NCI Thesaurus Property-3)
C0392747 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Percent change
CL Item
% Decrease (% decrease)
CL Item
% Increase (% increase)
MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement
Item
Smallest previous sum of the longest diameter (cm)
float
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25627 (NCI Thesaurus Property-3)
C0205156 (UMLS 2011AA Property-3)
C61422 (NCI Thesaurus Property-4)
C0547044 (UMLS 2011AA Property-4)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25697 (NCI Thesaurus ValueDomain-2)
C1515051 (UMLS 2011AA ValueDomain-2)
MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue
Item
Percent change ([Current - Smallest previous sum/Smallest previous sum] X 100)
float
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25627 (NCI Thesaurus Property-3)
C0205156 (UMLS 2011AA Property-3)
C25446 (NCI Thesaurus Property-4)
C0392747 (UMLS 2011AA Property-4)
C61422 (NCI Thesaurus Property-5)
C0547044 (UMLS 2011AA Property-5)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Percent change
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25627 (NCI Thesaurus Property-3)
C0205156 (UMLS 2011AA Property-3)
C25446 (NCI Thesaurus Property-4)
C0392747 (UMLS 2011AA Property-4)
C61422 (NCI Thesaurus Property-5)
C0547044 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
Percent change
CL Item
% Decrease (% decrease)
CL Item
% Increase (% increase)
Item Group
Non-target Lesions
NontargetLesionFollow-upAssessmentInd-2
Item
Was an assessment performed for non-target lesions at this visit?
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NontargetLesionPresentInd-2
Item
Are there any nontarget lesions?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
Item
Organ
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (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)
CL.9
Code List
Organ
CL Item
Ascites (Ascites)
C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Cervix Uteri (Cervix)
C12311 (NCI Thesaurus)
C0007874 (UMLS 2011AA)
CL Item
Fallopian Tube (Fallopian tube)
C12403 (NCI Thesaurus)
C0015560 (UMLS 2011AA)
CL Item
Gastrointestinal Tract (GI)
C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)
CL Item
Genitourinary (GU)
C25350 (NCI Thesaurus)
C0042066 (UMLS 2011AA)
CL Item
Head And Neck (Head and Neck)
C12418 (NCI Thesaurus)
C0460004 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Lymph Node (Lymph node)
C12745 (NCI Thesaurus)
C0024204 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
CL Item
Soft Tissue (Other soft tissue)
C12471 (NCI Thesaurus)
C0225317 (UMLS 2011AA)
CL Item
Ovary (Ovary)
C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)
CL Item
Peritoneum (Peritoneum)
C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)
CL Item
Pleural/pericardial Effusion (Pleural/pericardial effusion)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Uterus (Uterus)
C12405 (NCI Thesaurus)
C0042149 (UMLS 2011AA)
LesionNontargetSite
Item
Nontarget Lesion Site (Describe specific location)
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
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.10
Code List
Method of Evaluation
CL Item
Physical Exam (Physical exam)
CL Item
X-ray (X-ray)
CL Item
Ct Scan (CT scan)
CL Item
Spiral Ct Scan (Spiral CT scan)
CL Item
Mri Scan (MRI scan)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Lesion status
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.11
Code List
Lesion status
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present (Present)
C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
New (New)
C25586 (NCI Thesaurus)
C0205314 (UMLS 2011AA)
NontargetLesionBaselinePresentInd-2
Item
Was the non-target lesion identified on the baseline evaluation
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DistantMetastasisProgressionInd-3
Item
Has the patient been diagnosed with a distant metastatic progression that has not been previously reported
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
Item Group
Follow-up Status Of Target Lesions
Item
Target Lesion Response Status
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.14
Code List
Target Lesion Response Status
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Target Lesion Response Status
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.15
Code List
Target Lesion Response Status
CL Item
Complete Response (Complete Response)
CL Item
Partial Response (Partial Response)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Stable Disease (Stable Disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
Item
Non-Target Lesion Response Status
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.16
Code List
Non-Target Lesion Response Status
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Non-Target Lesion Response Status
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.17
Code List
Non-Target Lesion Response Status
CL Item
Complete Response (Complete Response)
CL Item
Incomplete Response/sd (Incomplete Response/SD)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
Item
Overall Response
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.18
Code List
Overall Response
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Overall Response Status at This Assessment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.19
Code List
Overall Response Status at This Assessment
CL Item
Complete Response (CR)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
Item Group
Footer
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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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