ID

7611

Beschreibung

CALGB: 90104 Eligibility Checklist Combination Chemotherapy in Treating Patients With Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE19FD2A-E369-6ABF-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE19FD2A-E369-6ABF-E034-0003BA12F5E7

Stichworte

Versionen (2)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Bladder Cancer NCT00014534 Treatment - CALGB: 90104 Eligibility Checklist - 2169226v3.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: CALGB: 90104 Eligibility Checklist
    1. No Instruction available.
Ccrr Module For Calgb: 90104 Eligibility Checklist
Beschreibung

Ccrr Module For Calgb: 90104 Eligibility Checklist

CALGB Study No.
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Patient's Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Patient Medical Record Number
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Participating Group Protocol Number
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Main Member Institution/Adjunct
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Patient No.
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Patients must have pathologic confirmation of complete resection of T3-4 and/or pelvic node positive transitional cell carcinoma of the bladder with negative margins
Beschreibung

PatientsmusthavepathologicconfirmationofcompleteresectionofT3-4and/orpelvicnodepositivetransitionalcellcarcinomaofthebladderwithnegativemargins

Datentyp

text

Pathological stages for patients with bladder cancer eligible for this trial include: Tany, N=, Mo; T3a, N0, M0; T3b, N0, M0; T4a, N0, M0
Beschreibung

Pathologicalstagesforpatientswithbladdercancereligibleforthistrialinclude:Tany,N=,Mo;T3a,N0,M0;T3b,N0,M0;T4a,N0,M0

Datentyp

text

Patients must have undergone cystoprostatectomy plus pelvic lympn node dissection for bladder cancer in men and cystectomy/total abdominal hysterectomy/bilateral/salpingo-oophorectomy plus pelvic lymph node dissection for bladder cancer in women
Beschreibung

Patientsmusthaveundergonecystoprostatectomypluspelviclympnnodedissectionforbladdercancerinmenandcystectomy/totalabdominalhysterectomy/bilateral/salpingo-oophorectomypluspelviclymphnodedissectionforbladdercancerinwomen

Datentyp

text

No prior systemic chemotherapy for any reason or irradiation of the bladder
Beschreibung

Nopriorsystemicchemotherapyforanyreasonorirradiationofthebladder

Datentyp

text

Greater than or equal to 6 weeks since the definitive surgery but not more than 3 years
Beschreibung

Greaterthanorequalto6weekssincethedefinitivesurgerybutnotmorethan3years

Datentyp

text

Paraffin tissue blocks or unstained slides of the primary tumor for immunohistochemical studies must be available
Beschreibung

Paraffintissueblocksorunstainedslidesoftheprimarytumorforimmunohistochemicalstudiesmustbeavailable

Datentyp

text

No evidence of another active cancer within 5 years prior to registration, except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix curatively treated. Patients who have a prostate cancer in the resected specimen are eligible, pro
Beschreibung

Noevidenceofanotheractivecancerwithin5yearspriortoregistration,exceptfornon-melanomacarcinomaoftheskinorinsitucarcinomaofthecervixcurativelytreated.Patientswhohaveaprostatecancerintheresectedspecimenareeligible,pro

Datentyp

text

Normal cardiac function, no evidence of NYHA functional class III or IV heart disease
Beschreibung

Normalcardiacfunction,noevidenceofNYHAfunctionalclassIIIorIVheartdisease

Datentyp

text

Normal cardiac function, patients must have no serious cardiac arrhythmias; including first, second and third degree heart block
Beschreibung

Normalcardiacfunction,patientsmusthavenoseriouscardiacarrhythmias;includingfirst,secondandthirddegreeheartblock

Datentyp

text

ECOG performace status 0-1
Beschreibung

ECOGperformacestatus0-1

Datentyp

text

Age greater than or equal to 18 years
Beschreibung

Age>=18years

Datentyp

text

ANC greater than or equal to 1500/mm^3
Beschreibung

ANCgreaterthanorequalto1500/mm^3

Datentyp

text

Platelet count greater than or equal to 150,000/mm^3
Beschreibung

Plateletcountgreaterthanorequalto150,000/mm^3

Datentyp

text

Bilirubin less than or equal to 1.5 x ULN
Beschreibung

Bilirubinlessthanorequalto1.5xULN

Datentyp

text

Serum creatinine less than 1.5 mg/dl or calculated creatinine clearance greater than or equal to 60 ml/min/1.73m^2 using Cockcroft-Gault equation
Beschreibung

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Alkaline phosphatase less than 2.0 x ULN
Beschreibung

Alkalinephosphataselessthan2.0xULN

Datentyp

text

AST less than 2.0 x ULN
Beschreibung

ASTlessthan2.0xULN

Datentyp

text

ANC patient's value
Beschreibung

LaboratoryProcedureNeutrophilResultSpecifiedValue

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
Platelet count patient's value
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Bilirubin ULN
Beschreibung

HepaticBilirubinLabUpperLimitNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Bilirubin Patient's value
Beschreibung

Lab,Hepatic,Bilirubin

Datentyp

float

Serum creatinine patient's value
Beschreibung

RenalCreatinineLabSpecifiedValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Alkaline phosphatase ULN
Beschreibung

Alkaline Phosphatase ULN

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Alkaline phosphatase patient's value
Beschreibung

Lab,Hepatic,AlkalinePhosphatase

Datentyp

float

AST ULN
Beschreibung

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
AST patient's value
Beschreibung

HepaticSGOT(AST)LabUnspecifiedValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
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
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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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: CALGB: 90104 Eligibility Checklist
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Ccrr Module For Calgb: 90104 Eligibility Checklist
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Main Member Institution/Adjunct
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Participating Group Patient No.
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
PatientsmusthavepathologicconfirmationofcompleteresectionofT3-4and/orpelvicnodepositivetransitionalcellcarcinomaofthebladderwithnegativemargins
Item
Patients must have pathologic confirmation of complete resection of T3-4 and/or pelvic node positive transitional cell carcinoma of the bladder with negative margins
text
Pathologicalstagesforpatientswithbladdercancereligibleforthistrialinclude:Tany,N=,Mo;T3a,N0,M0;T3b,N0,M0;T4a,N0,M0
Item
Pathological stages for patients with bladder cancer eligible for this trial include: Tany, N=, Mo; T3a, N0, M0; T3b, N0, M0; T4a, N0, M0
text
Patientsmusthaveundergonecystoprostatectomypluspelviclympnnodedissectionforbladdercancerinmenandcystectomy/totalabdominalhysterectomy/bilateral/salpingo-oophorectomypluspelviclymphnodedissectionforbladdercancerinwomen
Item
Patients must have undergone cystoprostatectomy plus pelvic lympn node dissection for bladder cancer in men and cystectomy/total abdominal hysterectomy/bilateral/salpingo-oophorectomy plus pelvic lymph node dissection for bladder cancer in women
text
Nopriorsystemicchemotherapyforanyreasonorirradiationofthebladder
Item
No prior systemic chemotherapy for any reason or irradiation of the bladder
text
Greaterthanorequalto6weekssincethedefinitivesurgerybutnotmorethan3years
Item
Greater than or equal to 6 weeks since the definitive surgery but not more than 3 years
text
Paraffintissueblocksorunstainedslidesoftheprimarytumorforimmunohistochemicalstudiesmustbeavailable
Item
Paraffin tissue blocks or unstained slides of the primary tumor for immunohistochemical studies must be available
text
Noevidenceofanotheractivecancerwithin5yearspriortoregistration,exceptfornon-melanomacarcinomaoftheskinorinsitucarcinomaofthecervixcurativelytreated.Patientswhohaveaprostatecancerintheresectedspecimenareeligible,pro
Item
No evidence of another active cancer within 5 years prior to registration, except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix curatively treated. Patients who have a prostate cancer in the resected specimen are eligible, pro
text
Normalcardiacfunction,noevidenceofNYHAfunctionalclassIIIorIVheartdisease
Item
Normal cardiac function, no evidence of NYHA functional class III or IV heart disease
text
Normalcardiacfunction,patientsmusthavenoseriouscardiacarrhythmias;includingfirst,secondandthirddegreeheartblock
Item
Normal cardiac function, patients must have no serious cardiac arrhythmias; including first, second and third degree heart block
text
ECOGperformacestatus0-1
Item
ECOG performace status 0-1
text
Age>=18years
Item
Age greater than or equal to 18 years
text
ANCgreaterthanorequalto1500/mm^3
Item
ANC greater than or equal to 1500/mm^3
text
Plateletcountgreaterthanorequalto150,000/mm^3
Item
Platelet count greater than or equal to 150,000/mm^3
text
Bilirubinlessthanorequalto1.5xULN
Item
Bilirubin less than or equal to 1.5 x ULN
text
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
Item
Serum creatinine less than 1.5 mg/dl or calculated creatinine clearance greater than or equal to 60 ml/min/1.73m^2 using Cockcroft-Gault equation
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Alkalinephosphataselessthan2.0xULN
Item
Alkaline phosphatase less than 2.0 x ULN
text
ASTlessthan2.0xULN
Item
AST less than 2.0 x ULN
text
LaboratoryProcedureNeutrophilResultSpecifiedValue
Item
ANC patient's value
float
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Platelets
Item
Platelet count patient's value
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Lab,Hepatic,Bilirubin
Item
Bilirubin Patient's value
float
RenalCreatinineLabSpecifiedValue
Item
Serum creatinine patient's value
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Alkaline Phosphatase ULN
Item
Alkaline phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline phosphatase patient's value
float
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
AST ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HepaticSGOT(AST)LabUnspecifiedValue
Item
AST patient's value
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
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
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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