ID

2893

Beschreibung

CALGB 90203: Surgery and Pathology Summary [Form C-1243 v1 11/06/2006] Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1F629E0A-52FD-74AF-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1F629E0A-52FD-74AF-E044-0003BA3F9857

Stichworte

19.09.12 19.09.12 -
09.01.15 09.01.15 - Martin Dugas

Hochgeladen am

19. September 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT00430183 Pathology - CALGB 90203: Surgery and Pathology Summary - 2526235v1.0

Modell
Details

Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

1 Formulare

StudyEvent: CALGB 90203: Surgery and Pathology Summary
1. Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Ccrr Module For Calgb 90202: Prostate Specific Antigen Form

CALGBFormIdentifierNumber

Item

CALGB Form (C-714)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

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

Are data amended

CL Item

Yes (yes)

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

PatientInitialsName

Item

Patient Initials (Last, First Middle)

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)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

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

ParticipatingGroupName

Item

Participating Group

text

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

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

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

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

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

Hospital Report (Prostatectomy)

Item Group

Intraoperative Report (prostatectomy)

HospitalDischargeDayCount

Item

Length of hospital stay (number of days)

double

C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C0012621 (NCI Metathesaurus Property)

SurgeryDuration

Item

Duration of Surgery (hrs min)

double

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)

BloodLossAmount

Item

Estimated Blood Loss (cc)

double

C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25559 (NCI Thesaurus Property)
C1517945 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)

ErythrocyteTransfusionAdministeredInd-2

Item

Did the patient require red blood cell (RBC) tranfusion (Recommended Term for CRF text "Was red cell transfusion required intraoperatively")

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12521 (NCI Thesaurus ObjectClass)
C0014792 (UMLS 2011AA ObjectClass)
C15408 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.2

Code List

Did the patient require red blood cell (RBC) tranfusion (Recommended Term for CRF text "Was red cell transfusion required intraoperatively")

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ErythrocyteTransfusionAutologousAdministeredUnitCount

Item

Number of autologous units

double

C12521 (NCI Thesaurus ObjectClass)
C0014792 (UMLS 2011AA ObjectClass)
C15408 (NCI Thesaurus ObjectClass)
C28000 (NCI Thesaurus Property)
C0439859 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

ErythrocyteTransfusionAutologousAdministeredUnitCount

Item

Number of autologous units

double

ErythrocyteTransfusionBloodBankAdministeredUnitCount

Item

Number of banked units

double

C12521 (NCI Thesaurus ObjectClass)
C0014792 (UMLS 2011AA ObjectClass)
C15408 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C51963 (NCI Thesaurus Property)
C0005770 (UMLS 2011AA Property)
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

ErythrocyteTransfusionBloodBankAdministeredUnitCount

Item

Number of banked units

double

ErythrocytePostoperativeTransfusionAdministeredInd-2

Item

Did the patient require red blood cell (RBC) transfusion postoperatively

text

C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C12521 (NCI Thesaurus ObjectClass)
C0014792 (UMLS 2011AA ObjectClass)
C15408 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.3

Code List

Did the patient require red blood cell (RBC) transfusion postoperatively

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Pathology: Prostatectomy

Item Group

Pathology: Prostatectomy

SurgeryDate

Item

Surgery Date (Recommended Term for CRF Text "Date of radical prostatectomy" - mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

ProstateSurgeryProcedure

Item

Type of Procedure (Recommended Term for CRF Text "Type of radical prostatectomy" - Mark one with an X.)

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.4

Code List

Type of Procedure (Recommended Term for CRF Text "Type of radical prostatectomy" - Mark one with an X.)

CL Item

Radical Prostatectomy, Retropubic (Radical prostatectomy open retropubic)

CL Item

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

CL Item

Radical Prostatectomy Laparoscopic Retropubic (Radical prostatectomy laparoscopic retropubic)

CL Item

Radical Prostatectomy, Perineal (Radical prostatectomy perineal)

PrimaryMalignantNeoplasmCompleteResectionInd-2

Item

Was a complete resection of the primary tumor done (Recommended Term for CRF Text "Was complete resection of the prostate achieved")

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.5

Code List

Was a complete resection of the primary tumor done (Recommended Term for CRF Text "Was complete resection of the prostate achieved")

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SurgicalMarginApicalProstateStatus

Item

Apical Surgical Margin (Surgical margin status For each, mark one with an X.)

text

C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25423 (NCI Thesaurus Property)
C0205111 (UMLS 2011AA Property)

CL.6

Code List

Apical Surgical Margin (Surgical margin status For each, mark one with an X.)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Examined (Not examined)

SurgicalMarginAnteriorStatus

Item

Anterior Surgical Margin

text

C25231 (NCI Thesaurus Property)
C0205094 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.7

Code List

Anterior Surgical Margin

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Examined (Not examined)

SurgicalMarginPosteriorStatus

Item

Posterior Surgical Margin

text

C25622 (NCI Thesaurus Property)
C0205095 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.8

Code List

Posterior Surgical Margin

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Examined (Not examined)

SurgicalMarginPosterolateralStatus

Item

Posterolateral Surgical Margin

text

C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C0332195 (NCI Metathesaurus Property)

CL.9

Code List

Posterolateral Surgical Margin

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Examined (Not examined)

SurgicalMarginBladderNeckStatus

Item

Bladder Neck Surgical Margin

text

C12336 (NCI Thesaurus Property)
C0227716 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.10

Code List

Bladder Neck Surgical Margin

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Examined (Not examined)

TumorRelativePositionType

Item

Tumor Location Relative Position (Recommended Term for CRF Text "Location of tumor in prostate" - Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C21480 (NCI Thesaurus Property)
C0080103 (UMLS 2011AA Property)
C25339 (NCI Thesaurus Property)
C0733755 (UMLS 2011AA Property)

CL.11

Code List

Tumor Location Relative Position (Recommended Term for CRF Text "Location of tumor in prostate" - Mark all that apply with an X.)

CL Item

Anterior (Anterior)

C25231 (NCI Thesaurus)
C0205094 (UMLS 2011AA)

CL Item

Posterior (Posterior)

C25622 (NCI Thesaurus)
C0205095 (UMLS 2011AA)

TumorProstateAreaType

Item

Area

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property)
C0205146 (UMLS 2011AA Property)

CL.12

Code List

Area

CL Item

Apex (Apex)

CL Item

Middle (Middle)

C25569 (NCI Thesaurus)
C0444598 (UMLS 2011AA)

CL Item

Base (Base)

C0178499 (NCI Metathesaurus)

CL Item

Seminal Vesicle (Seminal vesicle)

C12787 (NCI Thesaurus)
C0036628 (UMLS 2011AA)

CL Item

Other, Specify (Other)

TumorAreaSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25244 (NCI Thesaurus Property)
C0205146 (UMLS 2011AA Property)

ProstateTumorPositionType

Item

Zone

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25339 (NCI Thesaurus Property)
C0733755 (UMLS 2011AA Property)

CL.13

Code List

Zone

CL Item

Peripheral/central (Peripheral/central)

CL Item

Transition (Transition)

C75958 (NCI Thesaurus)
C2700061 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Not Specified (Not specified)

ProstateMalignantNeoplasmExtracapsularInvasionType

Item

Capsular invasion (Mark one with an X.)

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25502 (NCI Thesaurus Property)
C1517049 (UMLS 2011AA Property)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.14

Code List

Capsular invasion (Mark one with an X.)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Capsular Invasion (Invasion into but not through the capsule)

CL341519 (NCI Metathesaurus)

CL Item

Focal Extracapsular Extension (Focal extracapsular extension)

CL Item

Established Extracapsular Extension (Established extracapsular extension)

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.15

Code List

Invasion of seminal vesicle

CL Item

No (NO)

CL Item

Yes (YES)

SeminalVesicleInvasionLateralSite

Item

Seminal Vesicle Laterality (If yes, Mark one with an X.)

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.16

Code List

Seminal Vesicle Laterality (If yes, Mark one with an X.)

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

Both Seminal Vesicles (Both sides)

CL127024 (NCI Metathesaurus)

CL Item

Side Not Specified (Side not specified)

ProstateMalignantNeoplasmBladderNeckInvasionInd-2

Item

Tumor invasion into bladder neck

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C12336 (NCI Thesaurus Property)
C0227716 (UMLS 2011AA Property)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.17

Code List

Tumor invasion into bladder neck

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PrimaryTumorLateralityType

Item

Tumor Laterality (Mark one with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.18

Code List

Tumor Laterality (Mark one with an X.)

CL Item

Unilateral (Unilateral)

C28012 (NCI Thesaurus)
C0205092 (UMLS 2011AA)

CL Item

Bilateral (Bilateral)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

TumorMaximumDiameterMeasurement

Item

Tumor Size, Maximum Diameter (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25564 (NCI Thesaurus Property)
C0806909 (UMLS 2011AA Property)

TumorTotalVolumeMeasurement

Item

Total Tumor Volume (as measured by computer assisted morphometry cc/mL)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25335 (NCI Thesaurus Property)
C0449468 (UMLS 2011AA Property)

TumorMalignantPresentPercentageAmount

Item

Percent Involved (Recommended Term for CRF text "Percent of gland involved by carcinoma" by visual inspection %)

double

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25417 (NCI Thesaurus ValueDomain)

GleasonScorePrimaryPatternValue

Item

Gleason Grade, Primary

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)

GleasonScoreSecondaryPatternValue

Item

Gleason Grade, Secondary

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)

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)

ProstateTumorHistologicCategory

Item

Histologic Type (In addition to adenocarcinoma, mark all that apply with an X.)

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.19

Code List

Histologic Type (In addition to adenocarcinoma, mark all that apply with an X.)

CL Item

Small Cell Carcinoma (Small cell carcinoma)

C3915 (NCI Thesaurus)
C0262584 (UMLS 2011AA)

CL Item

Sarcomatoid Carcinoma (Sarcomatoid carcinoma)

C27004 (NCI Thesaurus)
C0205697 (UMLS 2011AA)

CL Item

Mucinous (colloid) Adenocarcinoma (Mucinous (colloid) adenocarcinoma)

CL Item

Signet Ring Cell Carcinoma (Signet ring cell carcinoma)

C3774 (NCI Thesaurus)
C0206696 (UMLS 2011AA)

CL Item

Prostatic Duct Adenocarcinoma (Prostatic duct adenocarcinoma)

CL Item

Adenosquamous Carcinoma (Adenosquamous carcinoma)

C3727 (NCI Thesaurus)
C0206623 (UMLS 2011AA)

CL Item

Squamous Cell Carcinoma (Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Urothelial Primary In Prostate (Urothelial primary in prostate)

CL Item

Other Specify (Other)

TumorHistologicCategorySpecify

Item

Other specify

text

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

Pathology: Lymphadenectomy

Item Group

Pathology: Lymphadenectomy

PelvicLymphadenectomyPerformedDate

Item

Pelvic lymphadenectomy Date (mm dd yyyy)

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)

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined

double

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

LymphNodePositiveCount

Item

Number of Positive Lymph Nodes

double

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodeDissectionAnatomicSite

Item

Which lymph node areas were dissected (Mark all that apply with an X.)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)

CL.20

Code List

Which lymph node areas were dissected (Mark all that apply with an X.)

CL Item

External Iliac (external iliac)

CL Item

Obturator Lymph Node (obturator)

C0229822 (NCI Metathesaurus)

CL Item

Hypogastric (hypogastric)

CL Item

Other Specify (other)

LymphNodeDissectionSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)

LymphNodePositiveGrossInvolvementInd-2

Item

Were the nodes grossly positive

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C43566 (NCI Thesaurus Property)
C0439806 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.21

Code List

Were the nodes grossly positive

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DiscontinuedProstatectomyPositiveLymphNodePresentInd

Item

Were positive lymph nodes the reason for aborting the prostatectomy

text

C25484 (NCI Thesaurus ObjectClass)
C1444662 (UMLS 2011AA ObjectClass)
C15307 (NCI Thesaurus ObjectClass)
C0033573 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.22

Code List

Were positive lymph nodes the reason for aborting the prostatectomy

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TumorExtranodalExtensionIndicator

Item

Extranodal extension (Mark one with an X.)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)
C25504 (NCI Thesaurus Property)
C1517067 (UMLS 2011AA Property)

CL.23

Code List

Extranodal extension (Mark one with an X.)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Indeterminate (INDETERMINATE)

C48658 (NCI Thesaurus)
C0205258 (UMLS 2011AA)

LymphNodeSpecimenFrozenSectionInd-2

Item

Was a frozen section of the lymph node(s) performed

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C67462 (NCI Thesaurus Property)
C0016741 (UMLS 2011AA Property)

CL.24

Code List

Was a frozen section of the lymph node(s) performed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Pathologic Disease Classification

Item Group

Pathologic Disease Classification

ProstateTumorPathologicTStage

Item

T Stage, Pathologic (CRF must use existing CDE which matches CAP/AJCC 2006 versions - no pathologic staging of tumor for T0/T1 in that system.)

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.25

Code List

T Stage, Pathologic (CRF must use existing CDE which matches CAP/AJCC 2006 versions - no pathologic staging of tumor for T0/T1 in that system.)

CL Item

Clinically Inapparent Tumor Not Palpable Nor Visible By Imaging (T1)

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.26

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)

Footer Module

Item Group

Ccrr Module For Calgb: 90202 Adverse Event Form

ResponsiblePersonName

Item

Completed by (Last name, First name)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date Form Completed (mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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Prostate Cancer NCT00430183 Pathology - CALGB 90203: Surgery and Pathology Summary - 2526235v1.0

Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

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