ID

3374

Beskrivning

RTOG 0534 I1: Initial Evaluation Form Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A2988DD-5C50-0AA9-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A2988DD-5C50-0AA9-E044-0003BA3F9857

Nyckelord

Uppladdad den

20 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT00567580 Pre-Study - RTOG 0534 I1: Initial Evaluation Form - 2602772v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: RTOG 0534 I1: Initial Evaluation Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Unnamed1

Item Group

Unnamed Module 1

ProtocolRTOGIdentifierNumber

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

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

InstitutionName

Item

Institution Name

text

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

InstitutionIdentifierNumber

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientInitialsName

Item

Patient Initials

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)

PatientRadiationTherapyOncologyGroupIdentifierNumber

Item

RTOG Patient ID

text

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

DataAmendedInd-3

Item

Amended Data

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Amended Data

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed2

Item Group

Unnamed Module 2

PatientAgeYearCount

Item

Age (years)

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

Performance Status (ZUBROD 0-5)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.2

Code List

Performance Status (ZUBROD 0-5)

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)

TestPerfomedDate

Item

Date Performed (History and Physical Examination)

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)

DigitalRectalExaminationAssessmentDate

Item

Date Performed (Digital Rectal Examination)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17631 (NCI Thesaurus ObjectClass)
C1384593 (UMLS 2011AA ObjectClass)

PriorCancerDiagnosisInd-3

Item

Has the patient had any prior cancer diagnosed (other than study site)

text

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

CL.3

Code List

Has the patient had any prior cancer diagnosed (other than study site)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorMalignantNeoplasmSite

Item

Prior malignancy site

text

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

CL.4

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)
C0332152 (UMLS 2011AA ObjectClass)
C14143 (NCI Thesaurus ObjectClass)
C0205282 (UMLS 2011AA ObjectClass)
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)

INTERCURRENT DISEASE

Item Group

Other Patient Disease Type

PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-2

Item

History of inflammatory bowel disease

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3138 (NCI Thesaurus Property)
C0021390 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.5

Code List

History of inflammatory bowel disease

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HepaticInfectionPersonalMedicalHistoryInd-3

Item

Does patient have a history of hepatitis B or hepatitis C infection

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.6

Code List

Does patient have a history of hepatitis B or hepatitis C infection

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CongestiveHeartFailureHistoryInd-2

Item

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

text

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

CL.7

Code List

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

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TransmuralMyocardialInfarctionPatientPersonalMedicalHistoryInd-3

Item

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

text

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

CL.8

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ChronicDiseaseInfectionInd-2

Item

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

text

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)
C0205191 (UMLS 2011AA ObjectClass)

CL.9

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ChronicObstructiveAirwaysDiseaseRespiratoryEventHospitalizationInd-2

Item

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

text

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)

CL.10

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ChronicDiseaseHepaticInsufficiencyInd-2

Item

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

text

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

CL.11

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientAcquiredImmunodeficiencySyndromeAssessmentInd-3

Item

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

text

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)
C0001175 (UMLS 2011AA Property)

CL.12

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Prostate: Prior Treatment

Item Group

Prostate: Prior Treatment

PatientPelvicExternalBeamRadiationTherapyBrachytherapyPersonalMedicalHistoryInd-2

Item

Prior radiation therapy (pelvic external beam or brachytherapy)

text

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

CL.13

Code List

Prior radiation therapy (pelvic external beam or brachytherapy)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientAndrogenSuppressionPersonalMedicalHistoryInd-2

Item

Prior hormonal therapy (Androgen Deprivation)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C15676 (NCI Thesaurus Property)
C1515985 (UMLS 2011AA Property)

CL.14

Code List

Prior hormonal therapy (Androgen Deprivation)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorHormonalTherapyBeginDate

Item

Date Prior hormonal therapy Started

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PriorHormonalTherapyEndDate

Item

Date Prior hormonal therapy Ended

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PatientOrchiectomyPersonalMedicalHistoryIndicator

Item

Prior hormonal therapy (ORCHIECTOMY)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15288 (NCI Thesaurus Property)
C0007347 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.15

Code List

Prior hormonal therapy (ORCHIECTOMY)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Unilateral (Yes, unilateral)

CL Item

Yes, Bilateral (Yes, bilateral)

Prostate: Initial Diagnosis

Item Group

Prostate: Initial Diagnosis

FirstBiopsyPositiveDate

Item

Date of Initial Diagnosis of Primary Tumor (PRE-OPERATIVE)

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

ProstateTumorHistologicCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (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.16

Code List

Histologic Type

CL Item

Adenocarcinoma/acinar (Adenocarcinoma/Acinar)

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)
C0205419 (UMLS 2011AA Property)

GleasonScorePrimaryPatternValue

Item

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

double

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)
C0449774 (UMLS 2011AA Property)

CL.17

Code List

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

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

Unknown (9)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

GleasonScoreSecondaryPatternValue

Item

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

double

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)
C0449774 (UMLS 2011AA Property)

CL.18

Code List

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

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

Unknown (9)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

GleasonScoreWorstPatternValue

Item

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

double

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)
C0449774 (UMLS 2011AA Property)

CL.19

Code List

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

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

Unknown (9)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

GleasonScoreCombinedPatternValue

Item

Gleason Score, Combined

double

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)
C0449774 (UMLS 2011AA Property)

CL.20

Code List

Gleason Score, Combined

CL Item

10 (10)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

CL Item

8 (8)

CL Item

9 (9)

Unnamed3

Item Group

Prostate: Disease Description Localized

PalpableProstaticFossaTumorPresentIndicator

Item

Palpable prostatic fossa mass

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25606 (NCI Thesaurus ObjectClass)
C0522499 (UMLS 2011AA ObjectClass)
C27959 (NCI Thesaurus ObjectClass)
C1522721 (UMLS 2011AA ObjectClass)
C34007 (NCI Thesaurus ObjectClass)
C0836913 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.21

Code List

Palpable prostatic fossa mass

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ProstaticFossaBiopsyUltrasoundImagingPerformedStatus

Item

Prostatic fossa biopsy (under ultrasound guidance)

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C27959 (NCI Thesaurus ObjectClass)
C1522721 (UMLS 2011AA ObjectClass)
C34007 (NCI Thesaurus ObjectClass)
C0836913 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17230 (NCI Thesaurus Property)
C0041618 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.22

Code List

Prostatic fossa biopsy (under ultrasound guidance)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes, Negative (Yes, negative)

CL Item

Yes, Positive (Yes, positive)

ProstaticFossaBiopsyPerformedDate

Item

Date of prostatic fossa biopsy

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C27959 (NCI Thesaurus ObjectClass)
C1522721 (UMLS 2011AA ObjectClass)
C34007 (NCI Thesaurus ObjectClass)
C0836913 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

ProstateSurgeryProcedure

Item

Type of Procedure (PROSTATECTOMY)

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)

CL.23

Code List

Type of Procedure (PROSTATECTOMY)

CL Item

Radical Prostatectomy, Retropubic (Radical prostatectomy retropubic)

CL Item

Radical Prostatectomy, Perineal (Radical prostatectomy perineal)

CL Item

Radical Prostatectomy, Laparoscopic (Radical prostatectomy laparoscopic)

CL Item

Suprapubic Prostatectomy (Suprapubic prostatectomy)

C0194828 (NCI Metathesaurus)

CL Item

Radical Prostatectomy Robotic-assisted (Radical prostatectomy robotic-assisted)

CL Item

Other Specify (Other)

ProstatectomyPerformedSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15307 (NCI Thesaurus ObjectClass)
C0033573 (UMLS 2011AA ObjectClass)

PriorProstatectomyDate

Item

Prior Prostatectomy Date

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15307 (NCI Thesaurus ObjectClass)
C0033573 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

DiseaseExtraprostaticExtensionInd-3

Item

Extraprostatic extension (EPE)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)
C25505 (NCI Thesaurus Property)
C1517078 (UMLS 2011AA Property)

CL.24

Code List

Extraprostatic extension (EPE)

CL Item

No (NO)

CL Item

Yes (YES)

DiseaseLateralityExtraprostaticExtensionType

Item

Extraprostatic extension laterality

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
C25505 (NCI Thesaurus Property)
C1517078 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.25

Code List

Extraprostatic extension laterality

CL Item

Both Sides (Both sides)

CL Item

Left Side (Left side)

CL Item

Right Side (Right side)

CL Item

Side Not Specified (Side not specified)

SeminalVesicleInvasionInd-3

Item

Invasion of seminal vesicle

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12787 (NCI Thesaurus ObjectClass)
C0036628 (UMLS 2011AA ObjectClass)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)

CL.26

Code List

Invasion of seminal vesicle

CL Item

No (NO)

CL Item

Yes (YES)

SeminalVesicleInvasionLateralSite

Item

Seminal Vesicle Laterality

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C12787 (NCI Thesaurus ObjectClass)
C0036628 (UMLS 2011AA ObjectClass)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)

CL.27

Code List

Seminal Vesicle Laterality

CL Item

Both Seminal Vesicles (Both sides)

CL127024 (NCI Metathesaurus)

CL Item

Structure Of Left Seminal Vesicle (Left side)

C0227980 (NCI Metathesaurus)

CL Item

Structure Of Right Seminal Vesicle (Right side)

C0227979 (NCI Metathesaurus)

CL Item

Side Not Specified (Side not specified)

ProstatectomyMarginStatus

Item

Prostatectomy margin

text

C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C15307 (NCI Thesaurus ObjectClass)
C0033573 (UMLS 2011AA ObjectClass)

CL.28

Code List

Prostatectomy margin

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PelvicLymphadenectomyPerformedInd-3

Item

Pelvic lymphadenectomy

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25399 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)
C15275 (NCI Thesaurus ObjectClass)
C0024203 (UMLS 2011AA ObjectClass)

CL.29

Code List

Pelvic lymphadenectomy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PelvicLymphadenectomyPerformedDate

Item

Pelvic lymphadenectomy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25399 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)
C15275 (NCI Thesaurus ObjectClass)
C0024203 (UMLS 2011AA ObjectClass)

PelvicLymphNodeDissectionType

Item

Extent of pelvic lymph node dissection

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25399 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)

CL.30

Code List

Extent of pelvic lymph node dissection

CL Item

Extended (Extended)

CL Item

Limited (Limited)

CL110648 (NCI Metathesaurus)

LymphNodeAvailableExaminedInd-2

Item

Is the number of lymph nodes examined available

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)

CL.31

Code List

Is the number of lymph nodes examined available

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RightLymphNodeExaminedTotalCount

Item

Number of lymph nodes examined right side

double

C25228 (NCI Thesaurus ObjectClass)
C0205090 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LeftLymphNodeExaminedTotalCount

Item

Number of lymph nodes examined left side

double

C25229 (NCI Thesaurus ObjectClass)
C0205091 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

NotOtherwiseSpecifiedLocationLymphNodeExaminedTotalCount

Item

Number of lymph nodes examined location not specified

double

C25341 (NCI Thesaurus ObjectClass)
C0450429 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C19594 (NCI Thesaurus ObjectClass)
C1518425 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodeInvolvementInd-3

Item

Is there lymph node involvement

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.32

Code List

Is there lymph node involvement

CL Item

No (NO)

CL Item

Yes (YES)

PSA MEASUREMENTS

Item Group

Study Entry Psa Measurements

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Item

Baseline PSA Value (per protocol definition)

double

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

BaselinePSADate

Item

Baseline PSA Date (< 30 days prior to registration)

date

C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus 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.40

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)
C0947322 (UMLS 2011AA Property)

CL.37

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)

Additional PSA measurements

Item Group

Unnamed Module 4a

PatientAdditionalProstate-SpecificAntigenAssessmentInd-2

Item

Additional PSA measurements (NOT REPORTED ABOVE)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.35

Code List

Additional PSA measurements (NOT REPORTED ABOVE)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Item

PSA Date (s)

date

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

Item

PSA Value (s)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

AssessmentLabUOM

Item

Unit of Measure

text

CL.40

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

CL.37

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)

Unnamed4

Item Group

Unnamed

PelvicComputedTomographyMagneticResonanceImagingDiagnosticImagingPerformedInd-2

Item

CT/MRI pelvis

text

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C16809 (NCI Thesaurus ObjectClass)
C0024485 (UMLS 2011AA ObjectClass)
C25399 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.38

Code List

CT/MRI pelvis

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AbdominalPelvisScanPerformedDate

Item

Date Performed

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)

BoneScanMedicalImagingAssessmentInd-3

Item

Bone scan

text

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

CL.39

Code List

Bone scan

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BoneScanMedicalImagingAssessmentDate

Item

Date performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass)

Baseline Lab Values

Item Group

Baseline Lab Values (hematologic)

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Item

WBC

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)

LaboratoryProcedureLeukocyteResultDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureHemoglobinResultSpecifiedValue

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)

LaboratoryProcedureHemoglobinResultDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

AssessmentLabUOM

Item

Unit of Measure

text

CL.40

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)

LaboratoryProcedurePlateletResultSpecifiedValue

Item

Peripheral Platelet Count (x 10^3 U/L)

double

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

LaboratoryProcedurePlateletResultDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Item

SGPT

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 Upper Limit Normal (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)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Item

SGOT

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 Upper Limit Normal (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)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureAlkalinePhosphataseResultValue

Item

Alkaline Phosphatase

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)

LaboratoryProcedureAlkalinePhosphataseResultLowerLimitNormalValue

Item

Alkaline Phosphatase Lower Limit Normal (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)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Item

Alkaline Phosphatase Upper Limit Normal (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)

LaboratoryProcedureAlkalinePhosphataseResultDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone (VALUE)

double

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

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone Lower Limit Normal

double

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

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)
C0039601 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

TestosteroneAssessmentDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2299 (NCI Thesaurus ObjectClass)
C0039601 (UMLS 2011AA ObjectClass)

Unnamed4

Item Group

Unnamed Module 3

ProstateTumorPathologicTStage

Item

T Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.41

Code List

T Stage, Pathologic

CL Item

Organ Confined (pT2)

CL Item

Unilateral (pT2a)

C28012 (NCI Thesaurus)
C0205092 (UMLS 2011AA)

CL Item

Bilateral (pT2b)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

CL Item

Bilateral (pT2c)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

CL Item

Extraprostatic Extension (pT3)

CL Item

Extraprostatic Extension (pT3a)

CL Item

Seminal Vesicle Invasion (pT3b)

CL Item

Invasion Of Bladder, Rectum (pT4)

ProstateTumorPathologicNStage

Item

N Stage, Pathologic

text

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

CL.42

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)
C0033572 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.43

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)
C0033572 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.44

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)

Unnamed5

Item Group

Unnamed

NeoadjuvantTherapyChemotherapyPriorProstatectomyAdministeredInd-2

Item

Neoadjuvant chemotherapy prior to prostatectomy

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15307 (NCI Thesaurus Property)
C0033573 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.45

Code List

Neoadjuvant chemotherapy prior to prostatectomy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorNeoadjuvantTherapyChemotherapyOtherDiseaseorDisorderAdministeredInd-2

Item

Prior neoadjuvant chemotherapy for any other disease site if given within 5 years prior to registration

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.46

Code List

Prior neoadjuvant chemotherapy for any other disease site if given within 5 years prior to registration

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorProstateGlandCryosurgeryBrachytherapyPerformedInd-2

Item

Prior cryosurgery or brachytherapy of the prostate

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C15215 (NCI Thesaurus ObjectClass)
C0010408 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.47

Code List

Prior cryosurgery or brachytherapy of the prostate

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Comments

Item Group

Footer

ResearchCommentsText

Item

Comments

text

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

ResponsiblePersonSignatureText

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Prostate Cancer NCT00567580 Pre-Study - RTOG 0534 I1: Initial Evaluation Form - 2602772v1.0

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