ID

8968

Beschreibung

NSABP PROTOCOL R-04: SURGERY FORM Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7ABE177-6C54-3DC5-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7ABE177-6C54-3DC5-E034-0003BA12F5E7

Stichworte

Kolorektale Tumoren

Klinische Studie [Dokumenttyp]

Treatment Form

27.08.12 27.08.12 -
09.01.15 09.01.15 - Martin Dugas

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT00058474 Treatment - NSABP PROTOCOL R-04: SURGERY FORM - 2086952v3.0

Modell
Details

(If a resection was not performed, submit supporting documentation and leave the remainder of the form blank.)

1 Formulare

StudyEvent: NSABP PROTOCOL R-04: SURGERY FORM
1. (If a resection was not performed, submit supporting documentation and leave the remainder of the form blank.)

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Ccrr Module For Nsabp Protocol R-04: Surgery Form

Patient Initials Last

Item

Last

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

Patient Initials First

Item

First

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

PatientMiddleInitialsName

Item

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)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)

Patient ID NSABP

Item

NSABP Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)

Person Completing Form Last Name

Item

Person Completing Form, Last Name (Person Completing Form, First Name)

text

C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)

Person Completing Form First Name

Item

Person Completing Form, First Name

text

C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)

Person Completing Form Phone

Item

Person Completing Form, Phone

text

C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)

Affiliate Name

Item

Institution Name / Affiliate

text

C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Data amended

Item

Are data amended

boolean

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

Perioperative Tumor Assessment of Clinical Response

Item Group

Perioperative Tumor Assessment Of Clinical Response

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Assessment Date

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

ColorectalCarcinomaPerioperativeClinicalResponseStatus

Item

Clinical response

text

C2955 (NCI Thesaurus ObjectClass)
C0009402 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property-2)
C1704632 (UMLS 2011AA Property-2)
C28374 (NCI Thesaurus Property-3)
C1518988 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.3

Code List

Clinical response

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Tumor Absent (Tumor absent)

CL Item

Tumor Present (Tumor present)

ColorectalCarcinomaPerioperativeClinicalResponseStatus

Item

Clinical response

text

CL.3

Code List

Clinical response

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Tumor Absent (Tumor absent)

CL Item

Tumor Present (Tumor present)

Vascular Access Device

Item Group

Vascular Access Device

CentralVenousAccessCatheterMedicalDeviceImplantationDate

Item

Date of placement

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17612 (NCI Thesaurus ObjectClass)
C1145640 (UMLS 2011AA ObjectClass)
C16830 (NCI Thesaurus ObjectClass-2)
C0025080 (UMLS 2011AA ObjectClass-2)
C51982 (NCI Thesaurus Property)
C0021107 (UMLS 2011AA Property)

CentralVenousAccessCatheterMedicalDeviceImplantationType

Item

Type (MARK ONE)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17612 (NCI Thesaurus ObjectClass)
C1145640 (UMLS 2011AA ObjectClass)
C16830 (NCI Thesaurus ObjectClass-2)
C0025080 (UMLS 2011AA ObjectClass-2)
C51982 (NCI Thesaurus Property)
C0021107 (UMLS 2011AA Property)

CL.4

Code List

Type (MARK ONE)

CL Item

Port-a-cath (Implanted port)

CL Item

Percutaneous Catheter (Percutaneous catheter)

CL Item

Peripherally Inserted Central Venous Catheter (PIC line)

Blood Transfusions

Item Group

Blood Transfusions

BloodTransfusionTimepointAdministeredType

Item

Blood transfusion

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C68568 (NCI Thesaurus Property)
C2348792 (UMLS 2011AA Property)
C15192 (NCI Thesaurus ObjectClass)
C0005841 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

CL.5

Code List

Blood transfusion

CL Item

Intraoperative (Intraoperative)

CL Item

Preoperative (Preoperative)

C54732 (NCI Thesaurus)
C0445204 (UMLS 2011AA)

CL Item

Within 30 Days Post-operative (Within 30 days post-operative)

WholeBloodTransfusionCount

Item

Total units whole blood

float

C0370231 (NCI Metathesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)

PackedRedBloodCellTransfusionReceivedUnitCount

Item

Total number of units PRBC

float

C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)

Surgery

Item Group

Surgery

SurgicalProcedureExcisionPerformedInd-2

Item

Did patient undergo surgical resection?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property-2)

PatientSurgicalResectionDate

Item

Date of Resection (month day year)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property)

ResectionNotPerformedReason

Item

Reason for no resection

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)

CL.7

Code List

Reason for no resection

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Local Regional Tumor Growth (Local regional tumor growth)

CL Item

Metastatic Disease (Metastatic disease)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Patient Refused (Patient refused)

CL Item

Second Primary Cancer (Second primary cancer)

ResectionNotPerformedSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)

CancerProgressionTimepointDiagnosisType

Item

Found on

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C68568 (NCI Thesaurus Property)
C2348792 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)

CL.8

Code List

Found on

CL Item

Intra-operatively (Intra-operatively)

CL Item

Pre-op Diagnostic Testing (Pre-op diagnostic testing)

TumorAdherenceInd-3

Item

Is there adherence to adjacent organs?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25729 (NCI Thesaurus Property)
C1510802 (UMLS 2011AA Property)

EnBlocResectionPerformedInd-3

Item

Was an "en bloc" resection performed?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C25733 (NCI Thesaurus ObjectClass-2)
C1516835 (UMLS 2011AA ObjectClass-2)

PrimaryTumorPostExcisionRemainingInd-3

Item

Residual Primary Tumor

boolean

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property-2)
C25649 (NCI Thesaurus Property-3)
C1527428 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

ExploratorySurgeryAbdominalCavityPerformedInd-2

Item

Was an abdominal exploration carried out?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C66747 (NCI Thesaurus ObjectClass)
C1880637 (UMLS 2011AA ObjectClass)

TumorLeakagePresentInd-3

Item

Was there tumor spillage?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C40417 (NCI Thesaurus ObjectClass)
C1519683 (UMLS 2011AA ObjectClass)

ColorectalSurgicalProcedureSphincterPreservedInd-2

Item

Was sphincter preserved

boolean

C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C28381 (NCI Thesaurus Property)
C1409894 (UMLS 2011AA Property)
C0456735 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

TotalMesorectalExcisionPerformedInd-2

Item

Was a total mesorectal excision performed?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C16180 (NCI Thesaurus ObjectClass)
C1273428 (UMLS 2011AA ObjectClass)

LymphNodeRemovedInd-3

Item

Were all suspicious lymph nodes removed?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

AbdominalCavityMetastasisPresentInd-3

Item

Were there any isolated distant or non-contiguous intra-abdominal mets (other than peri-rectal lymph node involvement)?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12664 (NCI Thesaurus ObjectClass)
C0230168 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)

MetastaticNeoplasmCompleteSurgicalResectionIndicator

Item

Metastasis completely resected

text

C3261 (NCI Thesaurus ObjectClass)
C2939420 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25698 (NCI Thesaurus Property-2)
C15232 (NCI Thesaurus Property-3)
C0728940 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.18

Code List

Metastasis completely resected

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

TumorPerforationInd

Item

Was there bowel perforation

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C4080 (NCI Thesaurus Property)
C0549099 (UMLS 2011AA Property)

PerforationOutsideTumorInd

Item

Indicate the type (perforation)

text

CL.20

Code List

Indicate the type (perforation)

CL Item

Contained (Contained)

CL Item

Free (Free)

ObstructionPresentInd-3

Item

Was there bowel obstruction

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C0028778 (NCI Metathesaurus ObjectClass)

Indicatethetype(tumor)

Item

Indicate the type (tumor)

text

CL.22

Code List

Indicate the type (tumor)

CL Item

Partial (Partial)

C25378 (NCI Thesaurus)
C0728938 (UMLS 2011AA)

CL Item

Complete (Complete)

C25250 (NCI Thesaurus)
C0205197 (UMLS 2011AA)

OstomyExcisionPerformedIndicator

Item

Was an ostomy created at the time of resection?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property-2)
C15290 (NCI Thesaurus ObjectClass)
C0029473 (UMLS 2011AA ObjectClass)

CL.23

Code List

Was an ostomy created at the time of resection?

CL Item

Yes, Colostomy (Yes, colostomy)

CL Item

Yes, Ileostomy (Yes, ileostomy)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LesionCount

Item

Number of primary tumors

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

DistalBorderColorectalCarcinomaAnatomicSite

Item

Location of distal edge of tumor

text

C25237 (NCI Thesaurus ObjectClass)
C0205108 (UMLS 2011AA ObjectClass)
C2955 (NCI Thesaurus ObjectClass-2)
C0009402 (UMLS 2011AA ObjectClass-2)
C25439 (NCI Thesaurus ObjectClass-3)
C1522411 (UMLS 2011AA ObjectClass-3)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.24

Code List

Location of distal edge of tumor

CL Item

Upper Rectum (11 Or More Cm From The Anal Verge) (Upper rectum (11 or more cm from the anal verge))

CL Item

Middle Rectum (6-10 Cm From The Anal Verge) (Middle rectum (6-10 cm from the anal verge))

CL Item

Lower Rectum (0-5 Cm From The Anal Verge) (Lower rectum (0-5 cm from the anal verge))

SurgeryPost-OperativeComplicationsInd-3

Item

Were there any Post-operative and Early Complications

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C25623 (NCI Thesaurus Property-2)

SurgicalProcedureComplicationType

Item

Mark all that apply

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)

CL.26

Code List

Mark all that apply

CL Item

Anastomotic Leak (Anastomotic leak)

CL048064 (NCI Metathesaurus)

CL Item

Bowel Obstruction/ileus (Bowel obstruction/ileus)

CL Item

Cardiopulmonary Complication (Cardiopulmonary complication)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Heart/lung Bypass (heart/lung bypass)

CL Item

Hemorrhage (HEMORRHAGE)

C26791 (NCI Thesaurus)
C0019080 (UMLS 2011AA)

CL Item

Intra-abdominal Abscess (Intra-abdominal abscess)

CL Item

Other, Specify (Other, Specify)

CL Item

Pneumonia (PNEUMONIA)

C3333 (NCI Thesaurus)
C0032285 (UMLS 2011AA)

CL Item

Renal Failure (Renal failure)

CL Item

Urinary Complication, Choose Type (Urinary complication, choose type)

CL Item

Wound Dehiscence/fistula (Wound dehiscence/fistula)

CL Item

Wound Infection (Wound infection)

C0043241 (NCI Metathesaurus)

SurgicalProcedureComplicationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)

SurgicalProcedureWoundInfectionAdverseEventAnatomicSite

Item

Wound infection, mark type

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C45234 (NCI Thesaurus Property-2)
C0043241 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)

CL.27

Code List

Wound infection, mark type

CL Item

Abdominal (Abdominal)

C25342 (NCI Thesaurus)
C0000726 (UMLS 2011AA)

CL Item

Perineal (Perineal)

C0442032 (NCI Metathesaurus)

UrinarySystemAdverseEventPresentType

Item

Urinary complication, choose type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C12413 (NCI Thesaurus ObjectClass-2)
C1508753 (UMLS 2011AA ObjectClass-2)

CL.28

Code List

Urinary complication, choose type

CL Item

Retention (Retention)

C38016 (NCI Thesaurus)
C0333117 (UMLS 2011AA)

CL Item

Infection (Infection)

C0021311 (NCI Metathesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Re-excisionPerformedInd-2

Item

Was a re-operation necessary?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C48600 (NCI Thesaurus ObjectClass)
C0184913 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

Pathology

Item Group

Pathology

SpecimenIdentifierNumber

Item

Pathology Accession Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)

ColorectalTumorPathologicTStage

Item

Pathologic T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.30

Code List

Pathologic T Stage

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Tumor Invades Submucosa (T1)

CL Item

Tumor Invades Muscularis Propria (T2)

CL Item

Tumor Invades Through The Muscularis Propria Into The Subserosa, Or Into Nonperitonealized Pericolic Or Perirectal Tissues (T3)

CL Item

Tumor Directly Invades Other Organs Or Structures, And/or Perforates Visceral Peritoneum (T4)

CL Item

Carcinoma In Situ: Intraepithelial Or Invasion Of Lamina Propria (Tis)

CL Item

Primary Tumor Cannot Be Assessed (TX)

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined

float

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

float

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

TissueSpecimenPathologyReportType

Item

Pathologic response

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C28277 (NCI Thesaurus Property)
C0807321 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)

CL.31

Code List

Pathologic response

CL Item

Evidence Of Invasive Tumor Cells (Evidence of invasive tumor cells)

CL Item

No Evidence Of Invasive Tumor Cells (No evidence of invasive tumor cells)

Longest Diameter of Lesion

Item

Longest Dimension of Tumor (cm)

float

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS CUI-1)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS CUI-2)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS CUI-3)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)

ProstateTumorHistologicCategory

Item

Histologic Type (mark one)

text

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

CL.32

Code List

Histologic Type (mark one)

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Adenosquamous carcinoma (Adenosquamous carcinoma)

CL Item

Medullary carcinoma (Medullary carcinoma)

CL Item

Mucinous (colloid) carcinoma (Mucinous (colloid) carcinoma)

CL Item

Signet-ring cell adenocarcinoma (Signet-ring cell adenocarcinoma)

CL Item

Small cell carcinoma (oat cell) (Small cell carcinoma (oat cell))

CL Item

Squamous cell carcinoma (Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Undifferentiated or solid (Undifferentiated or solid)

CL Item

Other, specify (Other, specify)

TumorHistologicVariationSpecify

Item

Other, specify (histologic type)

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)

VenousInvasionInd

Item

Venous Invasion

text

CL.33

Code List

Venous Invasion

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Indeterminate (Indeterminate)

C48658 (NCI Thesaurus)
C0205258 (UMLS 2011AA)

ColorectalTumorHistologicGrade

Item

Histologic Grade (Differentiation)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)

CL.34

Code List

Histologic Grade (Differentiation)

CL Item

High Grade (poor Differentiation And/or Undifferentiated) (High grade)

CL Item

Low Grade (well And/or Moderate Differentiation) (Low grade)

SurgicalResectionNegativeFindingMarginPerformedInd-2

Item

All surgical margins of resection are negative for tumor

boolean

C25698 (NCI Thesaurus ObjectClass)
C15232 (NCI Thesaurus ObjectClass-2)
C0728940 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38757 (NCI Thesaurus Property-2)
C1513916 (UMLS 2011AA Property-2)
C25563 (NCI Thesaurus Property-3)
C0205284 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

NeoplasmMarginInvolvedType

Item

Which margin was involved?

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25563 (NCI Thesaurus ObjectClass-2)
C0205284 (UMLS 2011AA ObjectClass-2)

CL.36

Code List

Which margin was involved?

CL Item

Circumferential (Circumferential)

CL Item

Distal (Distal)

C25237 (NCI Thesaurus)
C0205108 (UMLS 2011AA)

CL Item

Proximal (Proximal)

C25236 (NCI Thesaurus)
C0205107 (UMLS 2011AA)

ColorectalSurgicalMarginDistalDistanceMeasurement

Item

Distance from Primary Tumor to Distal Margin of Resection

float

C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
C25237 (NCI Thesaurus Property)
C0205108 (UMLS 2011AA Property)
C25167 (NCI Thesaurus Property-2)
C0012751 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

ColorectalSurgicalMarginProximalDistanceMeasurement

Item

Distance from Primary Tumor to Proximal Margin of Resection

float

C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
C25236 (NCI Thesaurus Property)
C0205107 (UMLS 2011AA Property)
C25167 (NCI Thesaurus Property-2)
C0012751 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

ColorectalSurgicalMarginCircumferentialDistanceMeasurement

Item

Distance to Nearest Radial Margin (Circumferential)

float

C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
CL124270 (NCI Metathesaurus Property)
C25167 (NCI Thesaurus Property)
C0012751 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25252 (NCI Thesaurus ValueDomain-2)
C0205288 (UMLS 2011AA ValueDomain-2)

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Versionen (2)

Hochgeladen am

DOI

Lizenz

Modell Kommentare :

Itemgroup Kommentare für :

Item Kommentare für :

Colorectal Cancer NCT00058474 Treatment - NSABP PROTOCOL R-04: SURGERY FORM - 2086952v3.0

(If a resection was not performed, submit supporting documentation and leave the remainder of the form blank.)

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