ID

11820

Beschreibung

RTOG-0521 I1: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Initial Evaluation Form NCT00288080 Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0C37725E-C9CF-4EEC-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0C37725E-C9CF-4EEC-E044-0003BA3F9857

Stichworte

Klinische Studie [Dokumenttyp]

Prostatatumoren

Pre-Study Form

Hochgeladen am

5. August 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Pre-Study Form Prostate Cancer High-Risk RTOG-0521 I1 NCT00288080

Modell
Details

Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

1 Formulare

StudyEvent: RTOG-0521 I1: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Initial Evaluation Form
1. Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

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)

RTOG Case number

Item

RTOG Case #

text

C16960 (NCI Thesaurus ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C49152 (NCI Thesaurus Property-2)
C25337 (NCI Thesaurus ValueDomain)
C1514695 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

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)

Prior cancer

Item Group

Prior malignancy

C2735088 (UMLS CUI-1)

Age

Item

Age

integer

C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])

ECOG Performance Status

Item

Performance Status (ZUBROD 0-5)

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 0-5)

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)

CL Item

Dead (5)

History of cancer

Item

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

boolean

C38148 (NCI Thesaurus ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
C2735088 (UMLS CUI [1])

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.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

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

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)

Other Patient Disease Type

Item Group

Other Patient Disease Type

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)

PatientAcquiredImmunodeficiencySyndromeAssessmentInd-3

Item

Does the patient have AIDS

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)

PatientPaclitaxelHypersensitivityPersonalMedicalHistoryInd-3

Item

Allergy (TAXOL)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1411 (NCI Thesaurus Property)
C0144576 (UMLS 2011AA Property)
C3114 (NCI Thesaurus Property-2)
C0020517 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

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)

Prostate: Prior Treatment

Item Group

Prostate: Prior Treatment

Prior Surgery

Item

Prior Surgery (RADICAL PROSTATECTOMY, CRYOSURGERY, OR BILATERAL ORCHIECTOMY)

boolean

C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)

Prior Radiation Therapy

Item

Prior Radiation Therapy (pelvic)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

PriorChemotherapyAdministeredInd-3

Item

Prior Chemotherapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

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)

HormoneTherapy5Alpha-ReductaseInhibitorPriorAdministeredInd-2

Item

5 alpha-reductase inhibitor

boolean

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C2319 (NCI Thesaurus Property-3)
C1318898 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorHormonalTherapyEndDate

Item

Prior Hormonal Therapy End Date

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

HormoneTherapyPriorTestosteroneAdministeredInd-3

Item

Testosterone (PRIOR HORMONAL THERAPY TYPE)

boolean

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PriorHormonalTherapyOtherAdministeredInd-3

Item

Prior Other Hormonal Therapy

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

HormoneTherapyAgentAdministeredSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PriorHormonalTherapyOtherAdministeredBeginDate

Item

Date Prior Other Hormonal Therapy Started

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

Prostate: Initial Diagnosis

Item Group

Prostate: Initial Diagnosis

FirstBiopsyPositiveDate

Item

Date of Initial Diagnosis of Primary Tumor

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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)

Prostate Tumor Histologic Type

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0033578 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])

CL.17

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)

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 ([sum of the primary and secondary])

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)

PSA at baseline

Item

Baseline PSA Value

float

C25294 (NCI Thesaurus ObjectClass)
C17525 (NCI Thesaurus Property)
C25213 (NCI Thesaurus Property-2)
C20200 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0138741 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])

LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeInd-2

Item

Pre-diagnostic PSA measurements (Additional PSA's obtained within 1 year prior to diagnosis if available)

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

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

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)

Prostate: Disease Description Localized

Item Group

Prostate: Disease Description Localized

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.25

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)

Prostate Cancer Staging

Item Group

Prostate Cancer Staging

ProstateTumor Stage

Item

T Stage, Clinical (AJCC 6TH EDITION)

text

C3262 (NCI Thesaurus ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C25398 (NCI Thesaurus Property)
C25728 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
C0033578 (UMLS CUI [1,1])
C0475455 (UMLS CUI [1,2])

CL.27

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.28

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.29

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.30

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)

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)

Neutrophil count

Item

ANC

float

C25294 (NCI Thesaurus ObjectClass)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0200633 (UMLS CUI [1])

Platelets

Item

Peripheral Platelet Count

float

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

ALT

Item

ALT (SGPT)

float

C13308 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201836 (UMLS CUI [1])

ALT ULN

Item

ALT (SGPT) ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

AST

Item

AST (SGOT)

float

C13308 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])

AST ULN

Item

AST (SGOT) ULN

float

C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

Bilirubin, total

Item

Total Bilirubin

float

C25304 (NCI Thesaurus ObjectClass)
C305 (NCI Thesaurus ObjectClass-2)
C13308 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1])

Bilirubin ULN

Item

Bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0005437 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

Alkaline Phosphatase

Item

Alkaline Phosphatase

float

C13308 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0201850 (UMLS CUI [1])

Alkaline Phosphatase ULN

Item

Alkaline Phosphatase ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

Testosterone

Item

Testosterone

float

C20200 (NCI Thesaurus Property)
C2299 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0039601 (UMLS CUI [1])

Testosterone LLN

Item

Testosterone LLN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C2299 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0039601 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])

Testosterone ULN

Item

Testosterone ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C2299 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0039601 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

PROSTATE: TREATMENT SCHEDULE (HORMONE THERAPY)

Item Group

Prostate: Treatment Schedule

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationName

Item

LHRH agonist

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C1910 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)

CL.32

Code List

LHRH agonist

CL Item

Eligard (Eligard)

CL Item

Lupron (Lupron)

C0701459 (NCI Metathesaurus)

CL Item

Not Started (Not started)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Viadur (Viadur)

CL Item

Zoladex (Zoladex)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate

Item

LHRH agonist start date

date

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

OralAntiandrogenTherapyAgentAdministeredName

Item

Oral antiandrogen taken

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

CL.33

Code List

Oral antiandrogen taken

CL Item

Casodex (Casodex)

C0591237 (NCI Metathesaurus)

CL Item

Eulexin (Eulexin)

CL Item

Not Started (Not started)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

OralAntiandrogenTherapyAgentAdministeredSpecify

Item

Other, specify

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

OralAntiandrogenTherapyAgentAdministeredBeginDate

Item

Oral Antiandrogen Start Date

date

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

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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Pre-Study Form Prostate Cancer High-Risk RTOG-0521 I1 NCT00288080

Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

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