ID

10754

Description

E2108 Step 2 Disease Evaluation Form (RECIST 1.1) NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E091CE3-4B63-4A3C-E040-BB89AD4304A1

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E091CE3-4B63-4A3C-E040-BB89AD4304A1

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/8/15 1/8/15 - 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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E2108 Step 2 Disease Evaluation Form (RECIST 1.1) NCT01242800

English

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

1 forms  
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

Patient Initials (Last, First)
Description

Patient Initials

Data type

text

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

Protocol Number ECOG

Data type

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
Description

Patient ID ECOG

Data type

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 Number
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
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
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Data type

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
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
On Treatment
Description

On Treatment

On Treatment Report Period (Choose one)
Description

Cycle number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Disease Assessment
Description

Disease Assessment

Were disease assessment results obtained this report period? (cycle)
Description

DiseaseAssessmentResultInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
TARGET LESIONS - NON-NODAL
Description

TARGET LESIONS - NON-NODAL

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
Site of Lesion (Multiple new lesions within an organ may be combined as a single site)
Description

Lesion Site, Primary

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25341
Site Code
Description

LesionMeasurableEvaluationAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C37894
UMLS 2011AA Property-2
C1513040
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
Date of Evaluation (M D Y)
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
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
Sum of Longest Diameters of All Non-Nodal Target Lesions
Description

NegationNodalTargetLesionSumLongestDiameterMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25594
UMLS 2011AA ObjectClass-2
C1518422
NCI Thesaurus ObjectClass-3
C25323
UMLS 2011AA ObjectClass-3
C0443268
NCI Thesaurus ObjectClass-4
C25702
UMLS 2011AA ObjectClass-4
C1521840
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25697
UMLS 2011AA Property-3
C1515051
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
TARGET LESIONS - NODAL
Description

TARGET LESIONS - NODAL

Shortest Axis of Lesions (mm)
Description

NodalTargetLesionShortDimensionMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25323
UMLS 2011AA ObjectClass-2
C0443268
NCI Thesaurus ObjectClass-3
C25702
UMLS 2011AA ObjectClass-3
C1521840
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
NCI Thesaurus Property-2
C25249
UMLS 2011AA Property-2
C1806781
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Check this box if node reaches sub-clinical level (<10 mm)
Description

NodalTargetLesionLessThanTenMillimeterShortDimensionText

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25323
UMLS 2011AA ObjectClass-2
C0443268
NCI Thesaurus ObjectClass-3
C25702
UMLS 2011AA ObjectClass-3
C1521840
NCI Thesaurus Property
C28251
UMLS 2011AA Property
C0439200
NCI Thesaurus Property-2
C61585
UMLS 2011AA Property-2
C0439092
NCI Thesaurus Property-3
C69122
UMLS 2011AA Property-3
C0205456
NCI Thesaurus Property-4
C25483
UMLS 2011AA Property-4
C0439534
NCI Thesaurus Property-5
C73939
UMLS 2011AA Property-5
C2350002
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Sum of Shortest Axes of All Nodal Lesions (mm)
Description

NodalTargetLesionSumShortDimensionMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25323
UMLS 2011AA ObjectClass-2
C0443268
NCI Thesaurus ObjectClass-3
C25702
UMLS 2011AA ObjectClass-3
C1521840
NCI Thesaurus Property
C25697
UMLS 2011AA Property
C1515051
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
NCI Thesaurus Property-3
C25249
UMLS 2011AA Property-3
C1806781
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Sum of Longest (Non-Nodal) and Shortest (Nodal) Axes of All Target Lesions (mm)
Description

TargetLesionSumShortLongestDimensionMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25702
UMLS 2011AA ObjectClass-2
C1521840
NCI Thesaurus Property
C25558
UMLS 2011AA Property
C1522425
NCI Thesaurus Property-2
C25697
UMLS 2011AA Property-2
C1515051
NCI Thesaurus Property-3
C25483
UMLS 2011AA Property-3
C0439534
NCI Thesaurus Property-4
C25249
UMLS 2011AA Property-4
C1806781
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Nontarget Lesions
Description

Nontarget Lesions

Follow-Up Status of Lesion (s)
Description

LesionResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Cytology Result (For Site Code 04 effusion/ascites ONLY)
Description

CytologyResultType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Unequivocal progressive disease in nontarget lesions is based on: (please describe)
Description

ProgressiveDiseaseNon-TargetLesionDescriptionText

Data type

text

Alias
NCI Thesaurus ObjectClass
C35571
UMLS 2011AA ObjectClass
C1335499
NCI Thesaurus Property
C3824
UMLS 2011AA Property
C0221198
NCI Thesaurus Property-2
C25592
UMLS 2011AA Property-2
C1518389
NCI Thesaurus Property-3
C25365
UMLS 2011AA Property-3
C0678257
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
New Lesions
Description

New Lesions

Was the appearance of any new lesions documented
Description

NewLesionAppearanceInd-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
C25586
UMLS 2011AA ObjectClass-2
C0205314
NCI Thesaurus Property
C25377
UMLS 2011AA Property
C0700364
Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Description

Overall Response Per Recist Criteria - Target, Nontarget And New Lesions

Best Overall Response to date (response status of all target, non-target, and new lesions)
Description

Best Overall Response

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C2986560
NCI Thesaurus ObjectClass-2
C25605
NCI Thesaurus ObjectClass-3
C25432
NCI Thesaurus Property
C25755
NCI Thesaurus ValueDomain
C25284
Has the patient progressed or relapsed
Description

DiseaseRelapseProgressionInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus Property-3
C19987
UMLS 2011AA Property-3
C0242656
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Progressive disease/Relapse observed date (M D Y)
Description

RelapseProgressionNeoplasmObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C18265
NCI Thesaurus ObjectClass-3
C25331
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Were circulating tumor cells (CTCs) assessed (during this reporting period)
Description

CirculatingTumorCellSpecimenCollectionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
CTC Count (If yes,)
Description

CirculatingTumorCellSpecimenCollectionCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
Symptomatic Deterioration
Description

Symptomatic Deterioration

Is there symptomatic deterioration of the patient's health status
Description

ResponseSymptomaticDeteriorationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25269
UMLS 2011AA Property
C0231220
NCI Thesaurus Property-2
C25751
UMLS 2011AA Property-2
C0868945
Specify symptomatic deterioration (If yes:)
Description

ResponseSymptomaticDeteriorationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25269
UMLS 2011AA Property
C0231220
NCI Thesaurus Property-2
C25751
UMLS 2011AA Property-2
C0868945
Symptomatic Deterioration Date (M D Y)
Description

ResponseSymptomaticDeteriorationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25269
UMLS 2011AA Property
C0231220
NCI Thesaurus Property-2
C25751
UMLS 2011AA Property-2
C0868945
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
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date (M D Y)
Description

Investigator Signature Date

Data type

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
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Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
Patient Initials
Item
Patient Initials (Last, First)
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)
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 Number
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)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
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 Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
On Treatment
Item
On Treatment Report Period (Choose one)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period (Choose one)
CL Item
At Decision For Local Therapy (At Decision for Local Therapy)
CL Item
6 Months Post Randomization (6 Months Post Randomization)
CL Item
18 Months Post Randomization (18 Months Post Randomization)
CL Item
30 Months Post Randomization (30 Months Post Randomization)
Item Group
Disease Assessment
DiseaseAssessmentResultInd-2
Item
Were disease assessment results obtained this report period? (cycle)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Item Group
TARGET LESIONS - NON-NODAL
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)
Lesion Site, Primary
Item
Site of Lesion (Multiple new lesions within an organ may be combined as a single site)
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
Item
Site Code
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C37894 (NCI Thesaurus Property-2)
C1513040 (UMLS 2011AA Property-2)
CL.12
Code List
Site Code
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
Effusion/ascites (Effusion/Ascites)
CL Item
Gi (GI)
CL Item
Gu (GU)
CL Item
Head & Neck (Head & Neck)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Nodes (Nodes)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.13
Code List
Method of Evaluation
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Chest X-ray (Chest x-ray)
CL Item
Ct Scan (CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Positron Emission Tomography (FDG-PET)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
CL Item
Pet/ct Scan (PET/CT scan)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LesionAssessmentDate
Item
Date of Evaluation (M D Y)
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)
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)
NegationNodalTargetLesionSumLongestDiameterMeasurement
Item
Sum of Longest Diameters of All Non-Nodal Target Lesions
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus ObjectClass-2)
C1518422 (UMLS 2011AA ObjectClass-2)
C25323 (NCI Thesaurus ObjectClass-3)
C0443268 (UMLS 2011AA ObjectClass-3)
C25702 (NCI Thesaurus ObjectClass-4)
C1521840 (UMLS 2011AA ObjectClass-4)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25697 (NCI Thesaurus Property-3)
C1515051 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item Group
TARGET LESIONS - NODAL
NodalTargetLesionShortDimensionMeasurement
Item
Shortest Axis of Lesions (mm)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25323 (NCI Thesaurus ObjectClass-2)
C0443268 (UMLS 2011AA ObjectClass-2)
C25702 (NCI Thesaurus ObjectClass-3)
C1521840 (UMLS 2011AA ObjectClass-3)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
NodalTargetLesionLessThanTenMillimeterShortDimensionText
Item
Check this box if node reaches sub-clinical level (<10 mm)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25323 (NCI Thesaurus ObjectClass-2)
C0443268 (UMLS 2011AA ObjectClass-2)
C25702 (NCI Thesaurus ObjectClass-3)
C1521840 (UMLS 2011AA ObjectClass-3)
C28251 (NCI Thesaurus Property)
C0439200 (UMLS 2011AA Property)
C61585 (NCI Thesaurus Property-2)
C0439092 (UMLS 2011AA Property-2)
C69122 (NCI Thesaurus Property-3)
C0205456 (UMLS 2011AA Property-3)
C25483 (NCI Thesaurus Property-4)
C0439534 (UMLS 2011AA Property-4)
C73939 (NCI Thesaurus Property-5)
C2350002 (UMLS 2011AA Property-5)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
NodalTargetLesionSumShortDimensionMeasurement
Item
Sum of Shortest Axes of All Nodal Lesions (mm)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25323 (NCI Thesaurus ObjectClass-2)
C0443268 (UMLS 2011AA ObjectClass-2)
C25702 (NCI Thesaurus ObjectClass-3)
C1521840 (UMLS 2011AA ObjectClass-3)
C25697 (NCI Thesaurus Property)
C1515051 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
C25249 (NCI Thesaurus Property-3)
C1806781 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
TargetLesionSumShortLongestDimensionMeasurement
Item
Sum of Longest (Non-Nodal) and Shortest (Nodal) Axes of All Target Lesions (mm)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25483 (NCI Thesaurus Property-3)
C0439534 (UMLS 2011AA Property-3)
C25249 (NCI Thesaurus Property-4)
C1806781 (UMLS 2011AA Property-4)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item Group
Nontarget Lesions
Item
Follow-Up Status of Lesion (s)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.9
Code List
Follow-Up Status of Lesion (s)
CL Item
Complete Response (CR)
CL Item
Incompl. Resp./sd (Incompl. resp./SD)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
C35571 (NCI Thesaurus-3)
C1335499 (UMLS 2011AA-4)
Item
Cytology Result (For Site Code 04 effusion/ascites ONLY)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.14
Code List
Cytology Result (For Site Code 04 effusion/ascites ONLY)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
ProgressiveDiseaseNon-TargetLesionDescriptionText
Item
Unequivocal progressive disease in nontarget lesions is based on: (please describe)
text
C35571 (NCI Thesaurus ObjectClass)
C1335499 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C25592 (NCI Thesaurus Property-2)
C1518389 (UMLS 2011AA Property-2)
C25365 (NCI Thesaurus Property-3)
C0678257 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
New Lesions
NewLesionAppearanceInd-2
Item
Was the appearance of any new lesions documented
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass-2)
C0205314 (UMLS 2011AA ObjectClass-2)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
Item Group
Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Item
Best Overall Response to date (response status of all target, non-target, and new lesions)
text
C3262 (NCI Thesaurus ObjectClass)
C2986560 (UMLS CUI-1)
C25605 (NCI Thesaurus ObjectClass-2)
C25432 (NCI Thesaurus ObjectClass-3)
C25755 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
CL.15
Code List
Best Overall Response to date (response status of all target, non-target, and new lesions)
CL Item
Complete Response (CR)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
Item
Has the patient progressed or relapsed
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.16
Code List
Has the patient progressed or relapsed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
RelapseProgressionNeoplasmObservedDate
Item
Progressive disease/Relapse observed date (M D Y)
date
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus ObjectClass-2)
C25331 (NCI Thesaurus ObjectClass-3)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CirculatingTumorCellSpecimenCollectionInd-2
Item
Were circulating tumor cells (CTCs) assessed (during this reporting period)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
CirculatingTumorCellSpecimenCollectionCount
Item
CTC Count (If yes,)
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
Item Group
Symptomatic Deterioration
ResponseSymptomaticDeteriorationInd-3
Item
Is there symptomatic deterioration of the patient's health status
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
ResponseSymptomaticDeteriorationSpecify
Item
Specify symptomatic deterioration (If yes:)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
ResponseSymptomaticDeteriorationDate
Item
Symptomatic Deterioration Date (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date (M D Y)
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)
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