ID

3447

Description

Baseline 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=A6277560-71F5-3D77-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6277560-71F5-3D77-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 9/20/12 9/20/12 -
  2. 6/2/15 6/2/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

September 20, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00058149 Response - Baseline Disease Evaluation Form (RECIST) - 2047526v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Baseline Disease Evaluation Form (RECIST)
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Registration Step
Description

RegistrationStep

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Unnamed2
Description

Unnamed2

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

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Are there any target lesions?
Description

TargetLesionInd

Data type

text

Target Lesions:
Description

Target Lesions:

Lesion Number
Description

Lesion,ReferenceNumber

Data type

double

Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site; report in a consistent manner on subsequent forms.)
Description

Lesion,AnatomicSite

Data type

text

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
C37894
UMLS 2011AA Property
C1513040
Other (specify site)
Description

Other(specifysite)

Data type

text

Method of Evaluation
Description

AssessmentType

Data type

text

Date of Evaluation (M D Y)
Description

AssessmentDate

Data type

date

Longest Diameter of Lesion(s) (cm)
Description

Lesion,TumorDiameter

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Sum of longest diameters of all target lesions (cm)
Description

Lesion,Diameter,LongestSum

Data type

double

Nontarget Lesions:
Description

Nontarget Lesions:

Lesion Number
Description

Lesion,ReferenceNumber

Data type

double

Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site; report in a consistent manner on subsequent forms.)
Description

Lesion,AnatomicSite

Data type

text

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
C37894
UMLS 2011AA Property
C1513040
Other (specify site)
Description

Other(specifysite)

Data type

text

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

CytologyResult

Data type

text

Alias
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Method of Evaluation
Description

AssessmentType

Data type

text

Date of Evaluation (M D Y)
Description

AssessmentDate

Data type

date

Unnamed3
Description

Unnamed3

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

Ccrr Module For Baseline Disease Evaluation Form (recist)
Description

Ccrr Module For Baseline Disease Evaluation Form (recist)

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Baseline Disease Evaluation Form (RECIST)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
Unnamed2
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Are there any target lesions?
text
CL.2
Code List
Are there any target lesions?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Target Lesions:
Lesion,ReferenceNumber
Item
Lesion Number
double
Lesion,AnatomicSite
Item
Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site; report in a consistent manner on subsequent forms.)
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)
C1513040 (UMLS 2011AA Property)
CL.5
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))
Other(specifysite)
Item
Other (specify site)
text
Item
Method of Evaluation
text
CL.6
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
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)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Lesion,Diameter,LongestSum
Item
Sum of longest diameters of all target lesions (cm)
double
Item Group
Nontarget Lesions:
Lesion,ReferenceNumber
Item
Lesion Number
double
Lesion,AnatomicSite
Item
Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site; report in a consistent manner on subsequent forms.)
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)
C1513040 (UMLS 2011AA Property)
CL.5
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))
Other(specifysite)
Item
Other (specify site)
text
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.7
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)
Item
Method of Evaluation
text
CL.6
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
Other (Other (specify in Comments))
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentDate
Item
Date of Evaluation (M D Y)
date
Item Group
Unnamed3
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 Baseline Disease Evaluation Form (recist)
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