ID

11238

Beschreibung

Z1031: Pre-resection Visit Form NCT00265759 Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FA5E66B8-9BAC-016B-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FA5E66B8-9BAC-016B-E034-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 26.06.15 26.06.15 -
Hochgeladen am

26. Juni 2015

DOI

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Z1031: Pre-resection Visit Form NCT00265759

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: Z1031: Pre-resection Visit Form
    1. No Instruction available.
Patient demographics
Beschreibung

Patient demographics

Visit
Beschreibung

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Patient ID (Pt. ID issued during registration or previously issued patient ID)
Beschreibung

Patient Study ID

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Institution No.
Beschreibung

Institution Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials (F M L)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Name
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Pre-resection assessment
Beschreibung

Pre-resection assessment

Date of Assessment (Year Month e.g., JAN Day)
Beschreibung

Assessment Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Dimension 1 (cm)
Beschreibung

TumorLargestDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Not done (or)
Beschreibung

AssessmentMethodText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Not done (or)
Beschreibung

AssessmentMethodText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Dimension 2
Beschreibung

TumorSecondDimensionMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Increase of >25% in clinical tumor size relative to baseline measurement (caliper)
Beschreibung

IncreasedTumorSizePresentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Metathesaurus ObjectClass
CL228347
NCI Metathesaurus ObjectClass-2
CL124321
Clinical evidence of increased nodal disease present
Beschreibung

IncreasedNodalDiseasePresentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25323
UMLS 2011AA ObjectClass-2
C0443268
NCI Metathesaurus ObjectClass
CL124321
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Increase of >25% in tumor size confirmed
Beschreibung

IncreasedTumorSizeConfirmedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Metathesaurus ObjectClass
CL228347
NCI Metathesaurus ObjectClass-2
CL124321
Increase of >25% in tumor size confirmed
Beschreibung

IncreasedTumorSizeConfirmedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Metathesaurus ObjectClass
CL228347
NCI Metathesaurus ObjectClass-2
CL124321
Does the patient have clinical or radiologic evidence of metastatic disease?
Beschreibung

MetastaticNeoplasmConfirmedDiagnosisInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ObjectClass
C3261
UMLS 2011AA ObjectClass
C2939420
Clinical evidence of new breast primary lesion identified and confirmed
Beschreibung

NewPrimaryBreastCancerConfirmedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C4872
UMLS 2011AA ObjectClass-3
C0678222
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
If any disease progression confirmed (mark one)
Beschreibung

ConfirmedDiseaseProgressionOutcomeStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25458
UMLS 2011AA ObjectClass
C0750484
NCI Thesaurus ObjectClass-2
C17747
UMLS 2011AA ObjectClass-2
C0242656
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Metathesaurus Property
CL158230
Other, specify
Beschreibung

ConfirmedDiseaseProgressionOutcomeSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25458
UMLS 2011AA ObjectClass
C0750484
NCI Thesaurus ObjectClass-2
C17747
UMLS 2011AA ObjectClass-2
C0242656
NCI Metathesaurus Property
CL158230
Completed by
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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No Instruction available.

1 Formulare
  1. StudyEvent: Z1031: Pre-resection Visit Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient demographics
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Visit
CL Item
Week 4 (Week 4)
CL Item
Week 8 (Week 8)
CL Item
Week 12 (Week 12)
CL Item
Week 16 (Week 16)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials (F M L)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Item Group
Pre-resection assessment
Assessment Date
Item
Date of Assessment (Year Month e.g., JAN Day)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
TumorLargestDimensionMeasurement
Item
Dimension 1 (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
AssessmentMethodText
Item
Not done (or)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
AssessmentMethodText
Item
Not done (or)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
TumorSecondDimensionMeasurement
Item
Dimension 2
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
IncreasedTumorSizePresentInd-2
Item
Increase of >25% in clinical tumor size relative to baseline measurement (caliper)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
CL228347 (NCI Metathesaurus ObjectClass)
CL124321 (NCI Metathesaurus ObjectClass-2)
IncreasedNodalDiseasePresentInd-2
Item
Clinical evidence of increased nodal disease present
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25323 (NCI Thesaurus ObjectClass-2)
C0443268 (UMLS 2011AA ObjectClass-2)
CL124321 (NCI Metathesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IncreasedTumorSizeConfirmedInd-2
Item
Increase of >25% in tumor size confirmed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
CL228347 (NCI Metathesaurus ObjectClass)
CL124321 (NCI Metathesaurus ObjectClass-2)
IncreasedTumorSizeConfirmedInd-2
Item
Increase of >25% in tumor size confirmed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
CL228347 (NCI Metathesaurus ObjectClass)
CL124321 (NCI Metathesaurus ObjectClass-2)
MetastaticNeoplasmConfirmedDiagnosisInd-2
Item
Does the patient have clinical or radiologic evidence of metastatic disease?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C3261 (NCI Thesaurus ObjectClass)
C2939420 (UMLS 2011AA ObjectClass)
NewPrimaryBreastCancerConfirmedInd-2
Item
Clinical evidence of new breast primary lesion identified and confirmed
boolean
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus ObjectClass-3)
C0678222 (UMLS 2011AA ObjectClass-3)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
If any disease progression confirmed (mark one)
text
C25458 (NCI Thesaurus ObjectClass)
C0750484 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass-2)
C0242656 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL158230 (NCI Metathesaurus Property)
CL.8
Code List
If any disease progression confirmed (mark one)
CL Item
Study Treatment Continued (Study treatment continued)
CL Item
Proceed To Chemotherapy (Proceed to chemotherapy)
CL Item
Proceed To Or (Proceed to OR)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ConfirmedDiseaseProgressionOutcomeSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus ObjectClass)
C0750484 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass-2)
C0242656 (UMLS 2011AA ObjectClass-2)
CL158230 (NCI Metathesaurus Property)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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