ID

6273

Beschreibung

RTOG 0920 OPEN Registration Worksheet - Step 2 Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0190014-3FCB-4E42-E040-BB89AD43786E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0190014-3FCB-4E42-E040-BB89AD43786E

Stichworte

Versionen (3)
  1. 18.12.14 18.12.14 - Martin Dugas
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 17.09.21 17.09.21 -
Hochgeladen am

18. Dezember 2014

DOI

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Head and Neck Cancer NCT00956007 Registration - RTOG 0920 OPEN Registration Worksheet - Step 2 - 3219537v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: RTOG 0920 OPEN Registration Worksheet - Step 2
    1. No Instruction available.
Module 1
Beschreibung

Module 1

Institutional person randomizing case
Beschreibung

RandomizationPersonName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25196
UMLS 2011AA ObjectClass
C0034656
Is the patient able to continue protocol treatment?
Beschreibung

ProtocolTherapeuticProcedureContinueAdministrationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If no, specify the reason the patient cannot continue to Step 2
Beschreibung

ProtocolTherapeuticProcedureDiscontinueAdministrationReason

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Specify the reason the patient cannot continue to Step 2
Beschreibung

ProtocolTherapeuticProcedureDiscontinueAdministrationSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Patient Initials (First Middle Last)
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
Verifying physician
Beschreibung

PhysicianPersonVerificationIdentifierName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C45513
UMLS 2011AA Property
C1711411
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
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
Module 1
Beschreibung

Module 1

Calendar base date (for Step 2)
Beschreibung

TherapeuticProcedureCalendarGenerationDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C19459
UMLS 2011AA Property
C1516147
NCI Thesaurus Property
C48151
UMLS 2011AA Property
C0079411
Randomization Date (for Step 2)
Beschreibung

PatientRandomizationDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
Patient has consented to take part in the Quality of Life Study
Beschreibung

PatientQualityofLifeConsentInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
If no, provide reason
Beschreibung

PersonQualityofLifeClinicalStudyRefuseConsentReason

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C49161
UMLS 2011AA Property
C1705116
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
If response is "2) Patient refused for other reason", specify the reason
Beschreibung

PersonQualityofLifeClinicalStudyRefuseConsentOtherSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C49161
UMLS 2011AA Property
C1705116
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C17649
UMLS 2011AA ValueDomain
C0205394
If response is "5) Other reason", specify the reason the patient will not participate in the quality of life component of the study
Beschreibung

PersonQualityofLifeClinicalStudyRefuseConsentSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C49161
UMLS 2011AA Property
C1705116
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
If the patient agreed to participate in the quality of life component, did the patient agree to participate in Vision Tree?
Beschreibung

PatientQualityofLifeRadiationTherapyOncologyGroupVendorConsentPatientConsentInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C19778
UMLS 2011AA Property
C1514695
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C68608
UMLS 2011AA Property
C0042462
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Disease Type
Beschreibung

PrimarySiteofDiseaseDisordersAnatomicSite

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C13717
UMLS 2011AA ObjectClass
C1515974
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
EGFR Expression
Beschreibung

LaboratoryProcedureEpidermalGrowthFactorReceptorGeneExpressionOutcomeStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17068
UMLS 2011AA Property
C0034802
NCI Thesaurus Property
C16608
UMLS 2011AA Property
C0017262
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Use of IGRT?
Beschreibung

ImageGuidedRadiationTherapyAdministeredInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass
C62727
UMLS 2011AA ObjectClass
C1831760
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: RTOG 0920 OPEN Registration Worksheet - Step 2
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Module 1
RandomizationPersonName
Item
Institutional person randomizing case
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25196 (NCI Thesaurus ObjectClass)
C0034656 (UMLS 2011AA ObjectClass)
Item
Is the patient able to continue protocol treatment?
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.1
Code List
Is the patient able to continue protocol treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If no, specify the reason the patient cannot continue to Step 2
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.2
Code List
If no, specify the reason the patient cannot continue to Step 2
CL Item
Progression Of Disease (Progression of disease)
CL Item
Patient Refusal (Patient refusal)
CL Item
Physician Preference (Physician preference)
CL Item
Failure To Submit Tissue Assay (Failure to submit tissue assay)
CL Item
Other (Other)
ProtocolTherapeuticProcedureDiscontinueAdministrationSpecify
Item
Specify the reason the patient cannot continue to Step 2
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientInitialsName
Item
Patient Initials (First Middle Last)
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)
PhysicianPersonVerificationIdentifierName
Item
Verifying physician
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
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)
Item Group
Module 1
TherapeuticProcedureCalendarGenerationDate
Item
Calendar base date (for Step 2)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C19459 (NCI Thesaurus Property)
C1516147 (UMLS 2011AA Property)
C48151 (NCI Thesaurus Property)
C0079411 (UMLS 2011AA Property)
PatientRandomizationDate
Item
Randomization Date (for Step 2)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
Item
Patient has consented to take part in the Quality of Life Study
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.3
Code List
Patient has consented to take part in the Quality of Life Study
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If no, provide reason
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property)
C1705116 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.4
Code List
If no, provide reason
CL Item
Patient Refused Due To Illness (Patient refused due to illness)
CL Item
Patient Refused For Other Reason (Patient refused for other reason)
CL Item
Not Approved By Institutional Irb (Not approved by institutional IRB)
CL Item
Tool Not Available In Patient's Language (Tool not available in patient's language)
CL Item
Other, Specify (Other, specify)
PersonQualityofLifeClinicalStudyRefuseConsentOtherSpecify
Item
If response is "2) Patient refused for other reason", specify the reason
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property)
C1705116 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
PersonQualityofLifeClinicalStudyRefuseConsentSpecify
Item
If response is "5) Other reason", specify the reason the patient will not participate in the quality of life component of the study
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property)
C1705116 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
If the patient agreed to participate in the quality of life component, did the patient agree to participate in Vision Tree?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C68608 (NCI Thesaurus Property)
C0042462 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
If the patient agreed to participate in the quality of life component, did the patient agree to participate in Vision Tree?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Disease Type
text
C13717 (NCI Thesaurus ObjectClass)
C1515974 (UMLS 2011AA ObjectClass)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
CL.6
Code List
Disease Type
CL Item
Larynx (Larynx)
C12420 (NCI Thesaurus)
C0023078 (UMLS 2011AA)
CL Item
Oral Cavity (Oral Cavity)
C12421 (NCI Thesaurus)
C0226896 (UMLS 2011AA)
CL Item
Oropharynx P16 Not Evaluable (Oropharynx p16 not evaluable)
CL Item
Oropharynx P16+ (Oropharynx p16+)
CL Item
Oropharynx P16- (Oropharynx p16-)
Item
EGFR Expression
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17068 (NCI Thesaurus Property)
C0034802 (UMLS 2011AA Property)
C16608 (NCI Thesaurus Property)
C0017262 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.7
Code List
EGFR Expression
CL Item
High (High)
CL Item
Low (Low)
C54722 (NCI Thesaurus)
C0205251 (UMLS 2011AA)
CL Item
Not Evaluable (Not Evaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item
Use of IGRT?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C62727 (NCI Thesaurus ObjectClass)
C1831760 (UMLS 2011AA ObjectClass)
CL.8
Code List
Use of IGRT?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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