ID

11423

Description

ANBL0321: CT/MRI Response Assessment Form NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B968DB9B-1F21-22F4-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B968DB9B-1F21-22F4-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/3/15 7/3/15 -
Uploaded on

July 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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ANBL0321: CT/MRI Response Assessment Form NCT00053326

English

To accurately assess response, the method used to measure the lesion size at study entry should be the same method that is used to measure the lesion when the response is declared.

1 forms  
Header
Description

Header

Study Number
Description

ProtocolCOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C39353
UMLS 2011AA Property-2
C1516477
Study Number
Description

ProtocolCOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C39353
UMLS 2011AA Property-2
C1516477
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
COG Number
Description

PatientCOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C39353
UMLS 2011AA Property-2
C1516477
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
Today's date
Description

Form Completion Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date worksheet entered into RDE
Description

DataEnteredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
CT/MRI Response Assessment
Description

CT/MRI Response Assessment

Date of response evaluation (The date shown can be edited. Please record the actual date of the radiological assessment that confirms the response status was made.)
Description

LesionAssessmentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Disease measurement at study entry (Disease measurement = sum of longest diameter in one dimension of all CT/MRI lesions)
Description

LongestLesionSumDiameterMeasurement

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ObjectClass
C25558
UMLS 2011AA ObjectClass
C1522425
NCI Thesaurus ObjectClass-2
C3824
UMLS 2011AA ObjectClass-2
C0221198
NCI Thesaurus Property-2
C25697
UMLS 2011AA Property-2
C1515051
Disease measurement at study entry (Disease measurement = sum of longest diameter in one dimension of all CT/MRI lesions)
Description

LongestLesionSumDiameterMeasurement

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ObjectClass
C25558
UMLS 2011AA ObjectClass
C1522425
NCI Thesaurus ObjectClass-2
C3824
UMLS 2011AA ObjectClass-2
C0221198
NCI Thesaurus Property-2
C25697
UMLS 2011AA Property-2
C1515051
Response by CT/MRI lesions (1. Required field)
Description

TumorResponseType

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
ICD-O Topography Code of Lesion (1a)
Description

LesionSiteICD-OCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
Largest Dimension (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
Method of measurement (1c)
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
other, Specify (1. If other is selected as method of measurement, this must be completed.)
Description

Evaluation method, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
New Lesion
Description

New Lesion

Were any new lesions detected (1. Required field)
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
If other lesions were detected at study entry, did any of those demonstrate progression at this evaluation? (1. Required field)
Description

NewLesionProgressionInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25331
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Ccrr Module For Anbl0321: Ct/mri Response Assessment Form
Description

Ccrr Module For Anbl0321: Ct/mri Response Assessment Form

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Similar models

To accurately assess response, the method used to measure the lesion size at study entry should be the same method that is used to measure the lesion when the response is declared.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
ProtocolCOGIdentifierNumber
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
ProtocolCOGIdentifierNumber
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Institution Name
Item
Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
PatientCOGIdentifierNumber
Item
COG Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
CT/MRI Response Assessment
LesionAssessmentDate
Item
Date of response evaluation (The date shown can be edited. Please record the actual date of the radiological assessment that confirms the response status was made.)
date
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
LongestLesionSumDiameterMeasurement
Item
Disease measurement at study entry (Disease measurement = sum of longest diameter in one dimension of all CT/MRI lesions)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
LongestLesionSumDiameterMeasurement
Item
Disease measurement at study entry (Disease measurement = sum of longest diameter in one dimension of all CT/MRI lesions)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
Item
Response by CT/MRI lesions (1. Required field)
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.1
Code List
Response by CT/MRI lesions (1. Required field)
CL Item
Complete Response (Complete response)
CL Item
Very good partial response (Very good partial response)
CL Item
Partial Response (Partial response)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation (Not evaluable)
CL Item
Death Prior To Completion Of Protocol Criteria (Early death)
CL Item
Incomplete Response Or Stable Disesase (Incomplete response/SD)
LesionSiteICD-OCode
Item
ICD-O Topography Code of Lesion (1a)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Longest Diameter of Lesion
Item
Largest Dimension (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
Method of measurement (1c)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.2
Code List
Method of measurement (1c)
CL Item
Mri (MRI)
CL Item
Spiral Ct Scan (Computed Tomography- spiral)
CL Item
Ct Scan (Computed Tomography- Conventional)
CL Item
Other, Specify (Other, Specify)
Evaluation method, specify
Item
other, Specify (1. If other is selected as method of measurement, this must be completed.)
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Item Group
New Lesion
NewLesionAppearanceInd-2
Item
Were any new lesions detected (1. Required field)
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
If other lesions were detected at study entry, did any of those demonstrate progression at this evaluation? (1. Required field)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25331 (NCI Thesaurus Property)
CL.4
Code List
If other lesions were detected at study entry, did any of those demonstrate progression at this evaluation? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a (N/A, No other lesions)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Ccrr Module For Anbl0321: Ct/mri Response Assessment Form
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