ID

548

Beschreibung

S1011 Prestudy Form (#8218) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=93990004-B6E8-D71A-E040-BB89AD433C84

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=93990004-B6E8-D71A-E040-BB89AD433C84

Stichworte

Harnblasentumoren

26.08.12 26.08.12 -
09.01.15 09.01.15 - Martin Dugas

Hochgeladen am

26. August 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Bladder Cancer NCT01224665 Pre-Study - S1011 Prestudy Form (#8218) - 3152929v1.0

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Details

Instructions: Submit this form within 7 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form. ELIGIBILITY VERIFICATION: Each of the fields below corresponds to a criterion in Section 5 and must be completed for patient to be eligible

1 Formulare

StudyEvent: S1011 Prestudy Form (#8218)
1. Instructions: Submit this form within 7 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form. ELIGIBILITY VERIFICATION: Each of the fields below corresponds to a criterion in Section 5 and must be completed for patient to be eligible

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Unnamed1

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

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)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

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)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteredInvestigatorName

Item

Physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

ParticipatingGroupName

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PATIENT AND DISEASE DESCRIPTION

Item Group

Patient And Disease Description

ZubrodPerformanceStatusScore

Item

Zubrod Performance Status Score (see section 10.5 of the protocol)

text

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.1

Code List

Zubrod Performance Status Score (see section 10.5 of the protocol)

CL Item

Normal Activity (0)

CL Item

Symptoms, But Nearly Fully Ambulatory (1)

CL Item

Some Bed Time, But Needs To Be In Bed <50% Of Normal Daytime (2)

CL Item

Needs To Be In Bed > 50% Of Normal Daytime (3)

CL Item

Unable To Get Out Of Bed (4)

PatientHeightMeasurement

Item

Height (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight (kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

ChestX-RayAssessmentDate

Item

Date of Chest X-ray (MM DD YYYY Please enter date of chest x-ray to rule out visceral or nodal metastatic disease)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass)

AbdominalPelvisScanPerformedDate

Item

Date of CT or MRI (MM DD YYYY Please enter date of CT or MRI to rule out visceral or nodal metastatic disease)

date

C12767 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)
C0000726 (NCI Metathesaurus ObjectClass)
C17999 (NCI Thesaurus ObjectClass)
C0441633 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

CurrentStageCompleteAssessmentDate

Item

Date Current Staging Assessment Completed (MM DD YYYY Please enter date of most recent TURBT, bimanual exam or cross sectional imaging for clinical staging of disease. For patients who have received neoadjuvant chemotherapy, please list the most recent prior to the initiation of therapy)

date

C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ObjectClass)
C1300072 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PATIENT AND DISEASE DESCRIPTION1

Item Group

Disease Description

BladderCarcinomaClinicalTStage

Item

Clinical T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C25398 (NCI Thesaurus ValueDomain)
C0205210 (UMLS 2011AA ValueDomain)
C4912 (NCI Thesaurus ValueDomain)
C0699885 (UMLS 2011AA ValueDomain)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25728 (NCI Thesaurus ValueDomain)
C0475455 (UMLS 2011AA ValueDomain)

CL.2

Code List

Clinical T Stage

CL Item

Tumor Invades Muscularis Propria (cT2)

CL Item

Tumor Invades Perivesical Tissue (cT3)

CL Item

Tumor Invades Prostatic Stroma, Uterus, Vagina (cT4a)

BimanualExamResultType

Item

Bimanual Exam Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25305 (NCI Thesaurus ObjectClass)
C0582103 (UMLS 2011AA ObjectClass)
C25433 (NCI Thesaurus ObjectClass)
C1511117 (UMLS 2011AA ObjectClass)

CL.3

Code List

Bimanual Exam Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Induration Only (Induration only)

CL Item

3 Dimensional Mass (3 dimensional mass)

CL Item

Fixed (Fixed)

BladderTumorHistologicCategory

Item

Histologic Type (Please select all that apply based on TURBT or biopsy; pure squamous cell carcinoma or pure adenocarcinoma not eligible)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.4

Code List

Histologic Type (Please select all that apply based on TURBT or biopsy; pure squamous cell carcinoma or pure adenocarcinoma not eligible)

CL Item

Urothelial Carcinoma (Urothelial cell carcinoma)

C4030 (NCI Thesaurus)
C0007138 (UMLS 2011AA)

CL Item

Squamous Cell Carcinoma (Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Micropapillary Transitional Cell Carcinoma (Micropapillary carcinoma)

C65182 (NCI Thesaurus)
C1266012 (UMLS 2011AA)

CL Item

Other Specify (Other, specify)

TumorHistologicCategorySpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

TumorHistologicVariationCategory

Item

Type of Variant Histology (if selected please specify)

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25713 (NCI Thesaurus Property)
C0205419 (UMLS 2011AA Property)

CL.5

Code List

Type of Variant Histology (if selected please specify)

CL Item

Urothelial Carcinoma (< 50% Urothelial cell carcinoma)

C4030 (NCI Thesaurus)
C0007138 (UMLS 2011AA)
C4030 (NCI Thesaurus)
C0007138 (UMLS 2011AA)

CL Item

Urothelial Carcinoma (>= 50% Urothelial cell carcinoma)

C4030 (NCI Thesaurus)
C0007138 (UMLS 2011AA)
C4030 (NCI Thesaurus)
C0007138 (UMLS 2011AA)

CL Item

Squamous Cell Carcinoma (< 50% Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Squamous Cell Carcinoma (>= 50% Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Adenocarcinoma (< 50% Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Adenocarcinoma (>= 50% Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Micropapillary Transitional Cell Carcinoma (< 50% Micropapillary carcinoma)

C65182 (NCI Thesaurus)
C1266012 (UMLS 2011AA)
C65182 (NCI Thesaurus)
C1266012 (UMLS 2011AA)

CL Item

Micropapillary Transitional Cell Carcinoma (>= 50% Micropapillary carcinoma)

C65182 (NCI Thesaurus)
C1266012 (UMLS 2011AA)
C65182 (NCI Thesaurus)
C1266012 (UMLS 2011AA)

PlannedSurgeryDate

Item

Date of Planned Surgery (MM DD YYYY)

date

C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25619 (NCI Thesaurus ObjectClass)
C1301732 (UMLS 2011AA ObjectClass)

LABORATORY VALUES

Item Group

Laboratory Values

LaboratoryProcedurePlateletResultUnspecifiedValue

Item

Peripheral Platelet Count (mcl)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Item

WBC (x 10^3/ mcL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Item

Hemoglobin (g/dL)

double

C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHematocritOutcomePercentageValue

Item

Hematocrit (%)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64796 (NCI Thesaurus Property)
C0018935 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Item

Total Bilirubin (mg/dL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue

Item

Total Bilirubin ULN (mg/dL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Item

SGPT (ALT) (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

SGPT (ALT) ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Item

SGOT (AST) (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlkalinePhosphataseResultValue

Item

Alkaline Phosphatase (U/L)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Item

Alkaline Phosphatase ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

Renal

Item Group

Laboratory Values1

LaboratoryProcedureCreatinineResultUnspecifiedValue

Item

Serum Creatinine (mg/dL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineResultUpperLimitofNormalValue

Item

Serum Creatinine ULN (mg/dL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

PRIOR TREATMENT RELATED TO THIS CANCER

Item Group

Prior Treatment Related To This Cancer

NeoadjuvantTherapyPriorChemotherapyAdministeredInd-3

Item

Prior Neoadjuvant Chemotherapy

text

C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.6

Code List

Prior Neoadjuvant Chemotherapy

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TreatmentNotBeginDescriptionSpecify

Item

Specify reason treatment not initiated

text

C15368 (NCI Thesaurus ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

NEOADJUVANT TREATMENT RELATED TO THIS BLADDER CANCER

Item Group

Neoadjuvant Treatment Related To This Bladder Cancer

ChemotherapyRegimenType

Item

Chemotherapy Regimen (select all that apply)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.7

Code List

Chemotherapy Regimen (select all that apply)

CL Item

Doxorubicin Vinblastine Methotrexate Cisplatin (MVAC)

C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
C930 (NCI Thesaurus)
C0042670 (UMLS 2011AA)

CL Item

Gemcitabine (Gemcitabine)

C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)

CL Item

Cisplatin (Cisplatin)

C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)

CL Item

Carboplatin (Carboplatin)

C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)

CL Item

Paclitaxel (Paclitaxel)

C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)

PriorChemotherapyRegimenText

Item

Specify agent (other)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

AgentCourseCount

Item

Number of Cycles

double

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

TreatmentStartDate

Item

Treatment Start Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

LastTreatmentDate

Item

Date of Last Treatment (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Item Kommentare für :

Bladder Cancer NCT01224665 Pre-Study - S1011 Prestudy Form (#8218) - 3152929v1.0

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