ID

10496

Description

Baseline Disease Evaluation Form (RECIST) NCT00058149 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

Lien

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

Mots-clés

Versions (3)
  1. 20/09/2012 20/09/2012 -
  2. 02/06/2015 02/06/2015 -
  3. 03/06/2015 03/06/2015 -
Téléchargé le

3 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Baseline Disease Evaluation Form (RECIST) NCT00058149

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: Baseline Disease Evaluation Form (RECIST)
    1. No Instruction available.
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Type de données

text

ECOG Patient ID
Description

ECOGPatientID

Type de données

text

Registration Step
Description

RegistrationStep

Type de données

text

Patient?s Name
Description

Patient'sName

Type de données

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Type de données

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Type de données

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Type de données

text

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

AmendedDataInd

Type de données

boolean

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

Target Lesions:

Are there any target lesions?
Description

TargetLesionInd

Type de données

boolean

Lesion Number
Description

Lesion,ReferenceNumber

Type de données

float

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

Type de données

text

Site Code
Description

LesionMeasurableEvaluationAnatomicSite

Type de données

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
Other (specify site)
Description

Other(specifysite)

Type de données

text

Method of Evaluation
Description

AssessmentType

Type de données

text

Date of Evaluation (M D Y)
Description

AssessmentDate

Type de données

date

Longest Diameter of Lesion(s) (cm)
Description

Lesion,TumorDiameter

Type de données

float

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

Lesion,Diameter,LongestSum

Type de données

float

Nontarget Lesions:
Description

Nontarget Lesions:

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

CytologyResult

Type de données

text

Alias
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Comments
Description

Comments

Comments
Description

Comments

Type de données

text

Investigator Signature
Description

InvestigatorSignature

Type de données

text

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

InvestigatorSignatureDate

Type de données

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 Formulaires
  1. StudyEvent: Baseline Disease Evaluation Form (RECIST)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
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:
TargetLesionInd
Item
Are there any target lesions?
boolean
Lesion,ReferenceNumber
Item
Lesion Number
float
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-2)
C1513040 (UMLS 2011AA Property-2)
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)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Lesion,Diameter,LongestSum
Item
Sum of longest diameters of all target lesions (cm)
float
Item Group
Nontarget Lesions:
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 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 Baseline Disease Evaluation Form (recist)
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