ID

2317

Beschreibung

ACOSOG-Z4099 Active Monitoring RECIST Measurement Form (Arm 2) Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9815654D-3AFA-EB3D-E040-BB89AD437C70

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9815654D-3AFA-EB3D-E040-BB89AD437C70

Stichworte

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

19. September 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT01336894 Response - ACOSOG-Z4099 Active Monitoring RECIST Measurement Form (Arm 2) - 3178204v1.0

Englisch

ALL ITEMS MUST BE COMPLETED

1 Formulare  
  1. StudyEvent: ACOSOG-Z4099 Active Monitoring RECIST Measurement Form (Arm 2)
    1. ALL ITEMS MUST BE COMPLETED
Header Module
Beschreibung

Header Module

Protocol Number
Beschreibung

ProtocolACOSOGIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C19712
UMLS 2011AA Property
C1515944
Patient ID
Beschreibung

PatientCoordinatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Initials (L F M)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Institution Number
Beschreibung

InstitutionIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution
Beschreibung

InstitutionName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Are data amended (check one if data amended, please circle in red when using paper forms)
Beschreibung

DataAmendedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Visit
Beschreibung

Visit

Visit (check one)
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
C25716
UMLS 2011AA ObjectClass
C0545082
Overall Response Status
Beschreibung

Overall Response Status

Overall Response Status at This Assessment (check one)
Beschreibung

OverallTumorResponseType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C25605
UMLS 2011AA ObjectClass
C1561607
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Was the appearance of any new lesions documented (If PD: check one NOTE: If PD is selected for Overall Response Status, and Yes is selected for "Was the appearance of any new lesions documented" end form)
Beschreibung

NewLesionAppearanceInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25377
UMLS 2011AA Property
C0700364
Overall Response Status
Beschreibung

Overall Response Status

Assessment date (dd MMM yyyy Assessment date is the date reflecting type of assessment, not the physician interpretation date. If tumor measurements are not required this cycle per Section 4.0, Assessment Date is the date the patient was evaluated )
Beschreibung

AssessmentPerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Non-nodal target lesion site(s) (Primary Tumor)
Beschreibung

NonNodalTargetLesionPresentSite

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25594
UMLS 2011AA ObjectClass
C1518422
NCI Thesaurus ObjectClass
C25323
UMLS 2011AA ObjectClass
C0443268
NCI Thesaurus ObjectClass
C25702
UMLS 2011AA ObjectClass
C1521840
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Method of Evaluation
Beschreibung

AssessmentMethodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Non-Nodal Longest Diameter of Lesion(s) (Primary Tumor cm)
Beschreibung

NegationNodalTargetLesionLongestDiameterMeasurement

Datentyp

double

Maßeinheiten
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25594
UMLS 2011AA ObjectClass
C1518422
NCI Thesaurus ObjectClass
C25323
UMLS 2011AA ObjectClass
C0443268
NCI Thesaurus ObjectClass
C25702
UMLS 2011AA ObjectClass
C1521840
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property
C25558
UMLS 2011AA Property
C1522425
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain
C25285
UMLS 2011AA ValueDomain
C1301886
cm
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Ähnliche Modelle

ALL ITEMS MUST BE COMPLETED

1 Formulare
  1. StudyEvent: ACOSOG-Z4099 Active Monitoring RECIST Measurement Form (Arm 2)
    1. ALL ITEMS MUST BE COMPLETED
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
ProtocolACOSOGIdentifierNumber
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (L F M)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
InstitutionIdentifierNumber
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionName
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Are data amended (check one if data amended, please circle in red when using paper forms)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended (check one if data amended, please circle in red when using paper forms)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Visit
Item
Visit (check one)
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)
C0545082 (UMLS 2011AA ObjectClass)
CL.2
Code List
Visit (check one)
CL Item
4 Weeks After Surgery/completion Of Stereotactic Body Radiation Therapy (4 weeks after surgery/completion of SBRT)
CL Item
3 Months After Completion Of Stereotactic Body Radiation Therapy (3 months after completion of SBRT)
CL Item
6 Months After Completion Of Stereotactic Body Radiation Therapy (6 months after completion of SBRT)
CL Item
9 Months After Completion Of Stereotactic Body Radiation Therapy (9 months after completion of SBRT)
CL Item
12 Months After Completion Of Stereotactic Body Radiation Therapy (12 months after completion of SBRT)
Item Group
Overall Response Status
Item
Overall Response Status at This Assessment (check one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass)
C1561607 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.3
Code List
Overall Response Status at This Assessment (check one)
CL Item
Not Evaluated (Not evaluated)
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)
Item
Was the appearance of any new lesions documented (If PD: check one NOTE: If PD is selected for Overall Response Status, and Yes is selected for "Was the appearance of any new lesions documented" end form)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
CL.4
Code List
Was the appearance of any new lesions documented (If PD: check one NOTE: If PD is selected for Overall Response Status, and Yes is selected for "Was the appearance of any new lesions documented" end form)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Overall Response Status
AssessmentPerformedDate
Item
Assessment date (dd MMM yyyy Assessment date is the date reflecting type of assessment, not the physician interpretation date. If tumor measurements are not required this cycle per Section 4.0, Assessment Date is the date the patient was evaluated )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
NonNodalTargetLesionPresentSite
Item
Non-nodal target lesion site(s) (Primary Tumor)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C25323 (NCI Thesaurus ObjectClass)
C0443268 (UMLS 2011AA ObjectClass)
C25702 (NCI Thesaurus ObjectClass)
C1521840 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.5
Code List
Method of Evaluation
CL Item
Ct Scan (CT scan)
CL Item
Pet/ct Scan (PET/CT scan)
NegationNodalTargetLesionLongestDiameterMeasurement
Item
Non-Nodal Longest Diameter of Lesion(s) (Primary Tumor cm)
double
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C25323 (NCI Thesaurus ObjectClass)
C0443268 (UMLS 2011AA ObjectClass)
C25702 (NCI Thesaurus ObjectClass)
C1521840 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain)
C1301886 (UMLS 2011AA ValueDomain)
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