ID

10421

Beschreibung

Follow-Up Disease Evaluation Form (RECIST) A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6868BEA-ECA3-53E6-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6868BEA-ECA3-53E6-E034-0003BA0B1A09

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 - Philipp Bruland
  2. 01.06.15 01.06.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

1. Juni 2015

DOI

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

Englisch

No Instruction available.

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

ECOG clinical trial administrative data

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

Registration Step
Beschreibung

RegistrationStep

Datentyp

text

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

CycleNumber

Datentyp

text

Patient?s Name
Beschreibung

Patient'sName

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Participating Group Patient ID
Beschreibung

ParticipatingGroupPatientID

Datentyp

text

Institution/Affiliate
Beschreibung

MainMemberInstitution/Affiliate

Datentyp

text

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

AmendedDataInd

Datentyp

boolean

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

Target Lesions:

Lesion Number
Beschreibung

Lesion,ReferenceNumber

Datentyp

float

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

Lesion,AnatomicSite

Datentyp

text

Site Code
Beschreibung

LesionMeasurableEvaluationAnatomicSite

Datentyp

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
Beschreibung

AssessmentType

Datentyp

text

Date of Evaluation (M D Y)
Beschreibung

AssessmentDate

Datentyp

date

Longest Diameter of Lesion(s) (cm)
Beschreibung

Lesion,TumorDiameter

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
For Identification: Document BASELINE Longest Diameter of Lesion (cm)
Beschreibung

BaselineLongestDiameterofLesion(cm)

Datentyp

text

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

Lesion,Diameter,LongestSum

Datentyp

float

Nontarget Lesions:
Beschreibung

Nontarget Lesions:

Follow-Up Status of Lesions
Beschreibung

Follow-UpStatusofLesions

Datentyp

text

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

CytologyResult

Datentyp

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)
Beschreibung

ProgressiveDiseaseNon-TargetLesionDescriptionText

Datentyp

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
Beschreibung

New Lesions

Was the appearance of any new lesions documented?
Beschreibung

NewLesionInd

Datentyp

text

Response Of Target Lesions This Reporting Period
Beschreibung

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?
Beschreibung

Hastheresponseofthetargetlesionschanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Response status at this assessment (target lesions)
Beschreibung

ResponseCriteria

Datentyp

text

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

PR/CRFirstObservedDate

Datentyp

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:)
Beschreibung

ProgressiveDiseaseObservedDate

Datentyp

date

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

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?
Beschreibung

Hastheoverallresponsechanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?

Datentyp

text

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

OverallTumorResponse

Datentyp

text

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

ResponseConfirmedInd

Datentyp

boolean

Symptomatic Deterioration
Beschreibung

Symptomatic Deterioration

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

SymptomaticDeteriorationInd

Datentyp

text

yes, specify
Beschreibung

SymptomaticDeteriorationSpecify

Datentyp

text

Symptomatic Deterioration Date (M D Y)
Beschreibung

SymptomaticDeteriorationDate

Datentyp

date

Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

Investigator Signature
Beschreibung

InvestigatorSignature

Datentyp

text

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

InvestigatorSignatureDate

Datentyp

date

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

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

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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Follow-Up Disease Evaluation Form (RECIST)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
For Identification: Document 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
Item
Was the appearance of any new lesions documented?
text
CL.8
Code List
Was the appearance of any new lesions documented?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes, record below)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Response Of Target Lesions This Reporting Period
Item
Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
Code List
Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
CL Item
No (no, skip to Overall Response)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Response status at this assessment (target lesions)
text
CL.13
Code List
Response status at this assessment (target lesions)
CL Item
Complete Response (CR (confirmed or unconfirmed))
CL Item
Partial Response (PR (confirmed or unconfirmed))
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease Or Progression (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
Item
Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.14
Code List
Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
CL Item
No (no, skip this section)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Overall response status at this assessment
text
CL.15
Code List
Overall response status at this assessment
CL Item
Complete Response (CR (confirmed or unconfirmed))
CL Item
Partial Response (PR (confirmed or unconfirmed))
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 (unknown))
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.)
boolean
Item Group
Symptomatic Deterioration
Item
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
text
CL.17
Code List
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes, specify)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SymptomaticDeteriorationSpecify
Item
yes, specify
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 Follow-up Disease Evaluation Form (recist)
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