ID

10503

Beschrijving

ECOG Follow-Up Disease Evaluation Form (RECIST)NCT00057876 Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A622D776-13BD-3BC1-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A622D776-13BD-3BC1-E034-0003BA0B1A09

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 02-06-15 02-06-15 -
  3. 03-06-15 03-06-15 -
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3 juni 2015

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Creative Commons BY-NC 3.0 Legacy
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ECOG Follow-Up Disease Evaluation Form (RECIST) NCT00057876

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: ECOG Follow-Up Disease Evaluation Form (RECIST)
    1. No Instruction available.
ECOG clinical trial administrative data
Beschrijving

ECOG clinical trial administrative data

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Cycle Number (leave blank if off-treatment or N/A)
Beschrijving

CycleNumber

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Participating Group Patient ID
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Are data amended? (If yes, please circle amended items in red)
Beschrijving

AmendedDataInd

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Target Lesions:
Beschrijving

Target Lesions:

Lesion Number
Beschrijving

Lesion,ReferenceNumber

Datatype

float

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

Lesion,AnatomicSite

Datatype

text

Site Code
Beschrijving

LesionMeasurableEvaluationAnatomicSite

Datatype

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
Beschrijving

AssessmentType

Datatype

text

Date of Evaluation (M D Y)
Beschrijving

AssessmentDate

Datatype

date

Longest Diameter of Lesion(s) (cm)
Beschrijving

Lesion,TumorDiameter

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Baseline Longest Diameter of Lesion (cm)
Beschrijving

BaselineLongestDiameterofLesion(cm)

Datatype

text

Sum of longest diameters of all target lesions (cm)
Beschrijving

Lesion,Diameter,LongestSum

Datatype

float

Nontarget Lesions:
Beschrijving

Nontarget Lesions:

Follow-Up Status of Lesions
Beschrijving

Follow-UpStatusofLesions

Datatype

text

Cytology Result (For Site Code 04 effusion/ascites ONLY)
Beschrijving

CytologyResult

Datatype

text

Alias
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)
Beschrijving

ProgressiveDiseaseNon-TargetLesionDescriptionText

Datatype

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
Beschrijving

New Lesions

Was the appearance of any new lesions documented?
Beschrijving

NewLesionInd

Datatype

boolean

Response Of Target Lesions This Reporting Period
Beschrijving

Response Of Target Lesions This Reporting Period

Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
Beschrijving

Hastheresponseofthetargetlesionschanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Response status at this assessment
Beschrijving

ResponseCriteria

Datatype

text

PR/CR first observed date (M D Y)
Beschrijving

PR/CRFirstObservedDate

Datatype

text

Alias
NCI Thesaurus Property
C18212
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C4870
UMLS 2011AA Property
C0677874
NCI Thesaurus Property-3
C25599
UMLS 2011AA Property-2
C1441672
Progressive disease observed date (For PD:)
Beschrijving

ProgressiveDiseaseObservedDate

Datatype

date

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

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

Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
Beschrijving

Hastheoverallresponsechanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Overall response status at this assessment
Beschrijving

OverallTumorResponse

Datatype

text

Has response been confirmed by second assessment? (Confirmation of response: For CR/PR, all assessments repeated >= 4 wks after onset of CR/PR.)
Beschrijving

ResponseConfirmedInd

Datatype

text

no
Beschrijving

no

Datatype

text

yes
Beschrijving

yes

Datatype

text

Symptomatic Deterioration
Beschrijving

Symptomatic Deterioration

Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
Beschrijving

SymptomaticDeteriorationInd

Datatype

text

no
Beschrijving

no

Datatype

text

yes
Beschrijving

yes

Datatype

text

yes, specify (symptomatic deterioration)
Beschrijving

SymptomaticDeteriorationSpecify

Datatype

text

Symptomatic Deterioration Date (M D Y)
Beschrijving

SymptomaticDeteriorationDate

Datatype

date

Comments
Beschrijving

Comments

Comments
Beschrijving

Comments

Datatype

text

Investigator Signature
Beschrijving

InvestigatorSignature

Datatype

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beschrijving

InvestigatorSignatureDate

Datatype

date

Ccrr Module For Ecog Follow-up Disease Evaluation Form (recist)
Beschrijving

Ccrr Module For Ecog Follow-up Disease Evaluation Form (recist)

Follow-up Status of Lesion(s)
Beschrijving

Lesion,Follow-upStatus

Datatype

text

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: ECOG Follow-Up Disease Evaluation Form (RECIST)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number (leave blank if off-treatment or N/A)
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Target Lesions:
Lesion,ReferenceNumber
Item
Lesion Number
float
Lesion,AnatomicSite
Item
Site of Lesion (Multiple new lesions within an organ may be combined as a single site.)
text
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.9
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 (specify Site) (Other (specify site))
Item
Method of Evaluation
text
CL.10
Code List
Method of Evaluation
CL Item
Clinical Examination (Clinical Exam)
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Ct Scan (CT Scan (non-spiral))
CL Item
Spiral Ct Scan (Spiral CT)
CL Item
Mri (MRI)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
CL Item
Other (Other (specify in Comments))
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentDate
Item
Date of Evaluation (M D Y)
date
Lesion,TumorDiameter
Item
Longest Diameter of Lesion(s) (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
BaselineLongestDiameterofLesion(cm)
Item
Baseline Longest Diameter of Lesion (cm)
text
Lesion,Diameter,LongestSum
Item
Sum of longest diameters of all target lesions (cm)
float
Item Group
Nontarget Lesions:
Item
Follow-Up Status of Lesions
text
CL.6
Code List
Follow-Up Status of Lesions
CL Item
Cr (CR)
CL Item
Incompl. Resp./sd (incompl. resp./SD)
CL Item
Pd (PD)
Item
Cytology Result (For Site Code 04 effusion/ascites ONLY)
text
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.11
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
NewLesionInd
Item
Was the appearance of any new lesions documented?
boolean
Item Group
Response Of Target Lesions This Reporting Period
Hastheresponseofthetargetlesionschanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?
Item
Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Response status at this assessment
text
CL.13
Code List
Response status at this assessment
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
Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status (unknown))
PR/CRFirstObservedDate
Item
PR/CR first observed date (M D Y)
text
C18212 (NCI Thesaurus Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus Property-2)
C0677874 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-3)
C1441672 (UMLS 2011AA Property-2)
ProgressiveDiseaseObservedDate
Item
Progressive disease observed date (For PD:)
date
Item Group
Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Hastheoverallresponsechanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?
Item
Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Overall response status at this assessment
text
CL.15
Code List
Overall response status at this assessment
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
Null (Insufficient evaluation to determine response status)
ResponseConfirmedInd
Item
Has response been confirmed by second assessment? (Confirmation of response: For CR/PR, all assessments repeated >= 4 wks after onset of CR/PR.)
text
no
Item
no
text
yes
Item
yes
text
Item Group
Symptomatic Deterioration
SymptomaticDeteriorationInd
Item
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
text
no
Item
no
text
yes
Item
yes
text
SymptomaticDeteriorationSpecify
Item
yes, specify (symptomatic deterioration)
text
SymptomaticDeteriorationDate
Item
Symptomatic Deterioration Date (M D Y)
date
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For Ecog Follow-up Disease Evaluation Form (recist)
Lesion,Follow-upStatus
Item
Follow-up Status of Lesion(s)
text
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