ID

11183

Beschreibung

RTOG 0815 I1: Radiation Therapy Oncology Group Phase III Randomized Study of Dose-Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Evaluation Form NCT00936390 Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=656A1892-7AD2-3044-E040-BB89AD432827

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=656A1892-7AD2-3044-E040-BB89AD432827

Stichworte

Klinische Studie [Dokumenttyp]

Baseline

Prostatatumoren

Hochgeladen am

21. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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RTOG 0815 I1: Radiation Therapy Oncology Group Phase III Randomized Study of Dose-Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Evaluation Form NCT00936390

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1 Formulare

StudyEvent: RTOG 0815 I1: Radiation Therapy Oncology Group Phase III Randomized Study of Dose-Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Evaluation Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

RTOG clinical trial administrative data

Item Group

RTOG clinical trial administrative data

Protocol ID RTOG

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

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)

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

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Trial subject ID RTOG

Item

RTOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Data amended

Item

Amended Data

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Miscellaneous Patient Assessment

Item Group

Miscellaneous Patient Assessment

ECOG Performance Status

Item

Performance Status (ZUBROD 0-4)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

Code List

Performance Status (ZUBROD 0-4)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

DiagnosticProcedurePersonalMedicalHistoryPhysicalExaminationDigitalRectalExaminationPerformedInd-2

Item

History and physical/digital rectal

boolean

C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17631 (NCI Thesaurus Property-2)
C1384593 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

DiagnosticProcedureAdultComorbidityEvaluationPerformedScore

Item

ACE 27 score

float

C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C17600 (NCI Thesaurus Property-3)
C0001675 (UMLS 2011AA Property-3)
C16457 (NCI Thesaurus Property-4)
C0009488 (UMLS 2011AA Property-4)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

TestPerfomedDate

Item

Date Performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25482 (NCI Thesaurus Property)
C0348026 (UMLS 2011AA Property)

PriorCancerDiagnosisInd-3

Item

Has the patient had any prior cancer diagnosed (invasive)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

PriorMalignantNeoplasmSite

Item

Prior malignancy site

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14143 (NCI Thesaurus ObjectClass-3)
C0205282 (UMLS 2011AA ObjectClass-3)
CL111053 (NCI Metathesaurus Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.5

Code List

Prior malignancy site

CL Item

Aml/mds (AML/MDS)

C9441 (NCI Thesaurus)

CL Item

Bcc (BCC)

CL Item

Bladder Is The Site Of Second Primary Or Recurrent Tumor (bladder)

CL Item

Brain Is The Site Of Second Primary Or Recurrent Tumor (brain)

CL Item

Colorectal (Colorectal)

C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)

CL Item

Esophageal (Esophageal)

C37950 (NCI Thesaurus)
C1522619 (UMLS 2011AA)

CL Item

Gastric (Gastric)

C13307 (NCI Thesaurus)
C1704242 (UMLS 2011AA)

CL Item

Liver Is The Site Of Second Primary Or Recurrent Tumor (liver)

CL Item

Lung Is The Site Of Second Primary Or Recurrent Tumor (lung)

CL Item

Melanoma (Melanoma)

C3224 (NCI Thesaurus)
C0025202 (UMLS 2011AA)

CL Item

Nhl (NHL)

CL Item

Other Hematologic (Other hematologic)

CL Item

Other Solid (Other solid)

CL Item

Pancreatic (Pancreatic)

C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)

CL Item

Renal (Renal)

C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Squamous-skin (Squamous-skin)

CL Item

Unknown Primary (Unknown primary)

PriorMalignantNeoplasmSpecify

Item

Specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14143 (NCI Thesaurus ObjectClass-3)
C0205282 (UMLS 2011AA ObjectClass-3)
CL111053 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

CancerAblationDate

Item

Date Eradicated (mm-yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20985 (NCI Thesaurus Property)
C0547070 (UMLS 2011AA Property)

BrachytherapyAdministeredInd-3

Item

Is patient receiving brachytherapy (LDR/HDR)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

MagneticResonanceImagingComputedTomographyDiagnosticImagingAbdominalCavityPelvisPhysicalExaminationInd-2

Item

CT/MRI abdomen/pelvis

boolean

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C0040405 (UMLS 2011AA ObjectClass-2)
C16809 (NCI Thesaurus ObjectClass-3)
C0024485 (UMLS 2011AA ObjectClass-3)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property-2)
C0230168 (UMLS 2011AA Property-2)
C12767 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

AbdominalPelvisScanPerformedDate

Item

Date Performed

date

C12767 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)
C0000726 (NCI Metathesaurus ObjectClass)
C17999 (NCI Thesaurus ObjectClass-2)
C0441633 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

BoneScanMedicalImagingAssessmentInd-3

Item

Bone scan

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)

Laboratory Procedure Date

Item

Date performed

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

TransrectalUltrasoundProstateAssessmentIndicator

Item

Transrectal Ultrasound

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)

CL.38

Code List

Transrectal Ultrasound

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TransrectalUltrasoundProstateAssessmentVolumeMeasurement

Item

Prostate volume

float

C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25335 (NCI Thesaurus ValueDomain-2)
C0449468 (UMLS 2011AA ValueDomain-2)

TransrectalUltrasoundProstateAssessmentDate

Item

Date performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)

ProstateCarcinomaAmericanUrologicalAssociationSymptomScore

Item

AUA score

text

C4863 (NCI Thesaurus ObjectClass)
C0600139 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus Property)
C1512894 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

ProstateCarcinomaAmericanUrologicalAssociationSymptomScoreDate

Item

Date performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C4863 (NCI Thesaurus ObjectClass)
C0600139 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus Property)
C1512894 (UMLS 2011AA Property)

PatientRiskEligibilityDeterminationInd-3

Item

Does the patient have 2 or 3 risk factors

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17102 (NCI Thesaurus Property)
C0035647 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)

OTHER PATIENT DISEASE TYPE

Item Group

Other Patient Disease Type

CongestiveHeartFailureHistoryInd-2

Item

Heart problems (unstable angina and/or CHF requiring hospitalization within the last 6 months)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

TransmuralMyocardialInfarctionPatientPersonalMedicalHistoryInd-3

Item

Heart problems (Transmural myocardial infarction within the last 6 months)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus ObjectClass-2)
C0027051 (UMLS 2011AA ObjectClass-2)
CL233186 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

ChronicDiseaseInfectionInd-2

Item

Infection (acute bacterial or fungal requiring intravenous antibiotics at the time of registration)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)

ChronicObstructiveAirwaysDiseaseRespiratoryEventHospitalizationInd-2

Item

COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at registration

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
C3199 (NCI Thesaurus ObjectClass)
C0024117 (UMLS 2011AA ObjectClass)
CL316903 (NCI Metathesaurus ObjectClass)

ChronicDiseaseHepaticInsufficiencyInd-2

Item

Hepatic Insufficiency (resulting in clinical jaundice and/or coagulation defects)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
C1306571 (NCI Metathesaurus Property)

PatientAcquiredImmunodeficiencySyndromeAssessmentInd-3

Item

Does the patient have AIDS (based upon current CDC definition)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2851 (NCI Thesaurus Property-2)
C0001175 (UMLS 2011AA Property-2)

Prostate: Prior Treatment

Item Group

Prostate: Prior Treatment

PatientProstateCarcinomaSurgicalProcedurePersonalMedicalHistoryInd-2

Item

Prior surgery

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C4863 (NCI Thesaurus Property-2)
C0600139 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientPelvicExternalBeamRadiationTherapyBrachytherapyPersonalMedicalHistoryInd-2

Item

Prior radiation therapy (pelvic)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15751 (NCI Thesaurus Property)
C1517033 (UMLS 2011AA Property)
C15195 (NCI Thesaurus Property-2)
C0006098 (UMLS 2011AA Property-2)
C25399 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientChemotherapyPersonalMedicalHistoryInd-2

Item

Prior chemotherapy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PriorHormonalTherapyAdministeredInd-3

Item

Prior Hormonal Therapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PatientFinasterideHormoneTherapyPersonalMedicalHistoryInd-2

Item

Prior finasteride therapy

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1099 (NCI Thesaurus Property)
C0060389 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C0278784 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientFinasterideHormoneTherapyPersonalMedicalHistoryEndDate

Item

Prior finasteride therapy end date

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1099 (NCI Thesaurus Property)
C0060389 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C0278784 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

HormoneTherapyDutasteridePriorAdministeredInd-2

Item

Prior dutasteride therapy

boolean

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C47503 (NCI Thesaurus Property-2)
C0666267 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

HormoneTherapyDutasteridePriorAdministeredEndDate

Item

Prior dutasteride therapy end date

date

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C47503 (NCI Thesaurus Property-2)
C0666267 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Prostate: Initial Diagnosis

Item Group

Prostate: Initial Diagnosis

ProstateTumorHistologicCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)

CL.18

Code List

Histologic Type

CL Item

Adenocarcinoma, Conventional, Not Otherwise Specified (Adenocarcinoma, conventional NOS)

CL Item

Other Specify (Other)

TumorHistologicVariationSpecify

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)
C25713 (NCI Thesaurus Property-2)
C0205419 (UMLS 2011AA Property-2)

Diagnosis Date

Item

Diagnosis Date

date

C25164 (NCI Thesaurus ValueDomain)
C2316983 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C15220 (NCI Thesaurus ObjectClass)

CoreBiopsyProstateGlandNeoplasmPerformedCount

Item

Total number of core biopsies taken

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount

Item

Number of positive core biopsies

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CoreBiopsyProstateGlandNeoplasmPerformedPercentageValue

Item

Total % of core biopsies taken

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

CoreBiopsyProstateGlandMalignantNeoplasmPerformedPercentageValue

Item

Total % of positive core biopsies taken

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

GleasonScorePrimaryPatternValue

Item

Gleason Score, Primary Pattern ([most frequently seen] 1-5, 9=unknown)

float

C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

GleasonScoreSecondaryPatternValue

Item

Gleason Score, Secondary Pattern ([second most frequently seen] 1-5, 9=unknown)

float

C25667 (NCI Thesaurus Property)
C0175668 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

GleasonScoreWorstPatternValue

Item

Gleason Score, Worst Pattern ([worst pathological grade seen in any specimen] 1-5, 9=unknown)

float

C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25719 (NCI Thesaurus Property)
C1522166 (UMLS 2011AA Property)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

GleasonScoreCombinedPatternValue

Item

Gleason Score, Combined

float

C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

STUDY ENTRY PSA MEASUREMENTS

Item Group

Study Entry Psa Measurements

BaselinePSADate

Item

Baseline PSA Date

date

C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Item

Baseline PSA Value

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

AssessmentLabUOM

Item

Unit of Measure

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.34

Code List

Unit of Measure

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Nanomoles Per Liter (nmol/l)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

PSAManufacturerAssayType

Item

Method of Assay

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus Property)
C0005507 (UMLS 2011AA Property)
C25392 (NCI Thesaurus Property-2)
C0947322 (UMLS 2011AA Property-2)

CL.27

Code List

Method of Assay

CL Item

Abbott Labs (Abbott)

CL Item

Bayer (Bayer)

CL Item

Dpc (DPC)

CL Item

Hybritech (Hybritech)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

Addtitional PSA Measurements

Item Group

Addtitional PSA Measurements

LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeInd-2

Item

Pre-diagnostic PSA measurements

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PSA date

Item

PSA Date (s)

date

C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

PSA

Item

PSA Value (s)

float

C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)

Cancer Staging

Item Group

Cancer Staging

Palpable Tumor

Item

Was the tumor palpable? (at study entry)

text

C25180 (NCI Thesaurus ValueDomain)
C0746412 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C25606 (NCI Thesaurus ObjectClass-2)

CL.28

Code List

Was the tumor palpable? (at study entry)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, <= 1/2 Of One Lobe (Yes, <= 1/2 of one lobe)

CL Item

Yes, > 1/2 Of One Lobe (Yes, > 1/2 of one lobe)

CL Item

Yes, Both Lobes (Yes, both lobes)

CL Item

Yes, Nos (Yes, NOS)

DiseaseExtracapsularExtensionInd-3

Item

Extracapsular Extension? (by clinical examination)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)

ProstateTumorClinicalTStage

Item

T Stage, Clinical (AJCC 6th Edition)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.30

Code List

T Stage, Clinical (AJCC 6th Edition)

CL Item

Tumor Incidental Histologic Finding In 5% Or Less Of Tissue Resected (T1a)

CL Item

Tumor Incidental Histologic Finding In More Than 5% Of Tissue Resected (T1b)

CL Item

Tumor Identified By Needle Biopsy (eg, Because Of Elevated Psa) (T1c)

CL Item

Tumor Confined Within The Prostate (T2)

CL Item

Tumor Involves One Lobe (T2a)

CL Item

Tumor Involves Both Lobes (T2b)

CL Item

Tumor Involves Both Lobes (T2c)

CL Item

Tumor Extends Through The Prostate Capule (T3)

CL Item

Extracapsular Extension (unilateral Or Bilateral) (T3a)

CL Item

Tumor Invades Seminal Vesicle(s) (T3b)

CL Item

Tumor Is Fixed Or Invades Adjacent Structures Other Than Seminal Vesicles: Bladder Neck, External Sphincter, Or Rectum, Levator Muscles, And/or Pelvic Wall (T4)

CL Item

Primary Tumor Cannot Be Assessed (TX)

ProstateTumorPathologicNStage

Item

N Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.31

Code List

N Stage, Pathologic

CL Item

No Regional Lymph Node Metastasis (pN0)

CL Item

Metastatis In Regional Lymph Node Or Nodes (see Ajcc Definition) (pN1)

CL Item

Regional Lymph Nodes Cannot Be Assessed (pNX)

ProstateTumorClinicalNStage

Item

N Stage, Clinical (RADIOGRAPHIC)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.32

Code List

N Stage, Clinical (RADIOGRAPHIC)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastatis In Regional Lymph Node Or Nodes (see Ajcc Definition) (N1)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

ProstateTumorClinicalMStage

Item

M Stage, Clinical

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.33

Code List

M Stage, Clinical

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis (M1)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)

CL Item

Nonregional Lymph Node(s) (M1a)

CL Item

Bone(s) (M1b)

CL Item

Other Site(s) (M1c)

CL Item

Distant Metastasis Cannot Be Assessed (MX)

Baseline Lab Values

Item Group

Baseline Lab Values (hematologic)

Leukocytes (WBC)

Item

WBC

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Hemoglobin

Item

Hemoglobin

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

ANC

Item

ANC

float

C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Platelets

Item

Platelet count

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone (VALUE)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone Lower Limit Normal

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Item

Testosterone Upper Limit Normal

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeText

Item

SGPT (ALT) or SGOT (AST) (Test)

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property-2)
C64433 (NCI Thesaurus Property-3)
C0201836 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue

Item

SGPT (ALT) or SGOT (AST) (Value)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property-2)
C64433 (NCI Thesaurus Property-3)
C0201836 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeDate

Item

Date performed

date

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property-2)
C64433 (NCI Thesaurus Property-3)
C0201836 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Comments

Item Group

Footer

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Responsible Person Signature

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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RTOG 0815 I1: Radiation Therapy Oncology Group Phase III Randomized Study of Dose-Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Evaluation Form NCT00936390

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