ID

3000

Beskrivning

Z5041 - OPEN Enrollment Form Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7FFA1514-8347-A58F-E040-BB89AD4376E5

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7FFA1514-8347-A58F-E040-BB89AD4376E5

Nyckelord

Uppladdad den

19 september 2012

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Pancreatic Cancer NCT00733746 Registration - Z5041 - OPEN Enrollment Form - 3013792v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: Z5041 - OPEN Enrollment Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Demography Section

Item Group

Patient Information

PersonBirthDate

Item

Date of Birth (month day year)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)

PersonGenderTextType

Item

Gender of a Person

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)

CL.1

Code List

Gender of a Person

CL Item

Female Gender (Female Gender)

C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)

CL Item

Male Gender (Male Gender)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

EthnicGroupCategoryText

Item

Ethnicity

text

C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16564 (NCI Thesaurus ObjectClass)
C0015031 (UMLS 2011AA ObjectClass)

CL.2

Code List

Ethnicity

CL Item

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)

C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)

CL Item

A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)

C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)

CL Item

Not Provided Or Available (Not reported)

C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)

PersonAddressCountryName

Item

Country of Residence

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

PersonAddressPostalCode

Item

Zip code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

PatientRaceCategory

Item

Race

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.3

Code List

Race

CL Item

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)

C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)

CL Item

Not Provided Or Available (Not Reported)

C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientPaymentType

Item

Method of Payment

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)

CL.4

Code List

Method of Payment

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid and Medicare)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare and Private Insurance)

CL Item

Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))

CL Item

Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))

CL Item

No Means Of Payment (no Insurance) (No means of payment (no insurance))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Private Insurance (Private Insurance)

CL Item

Self Pay (no Insurance) (Self Pay (No Insurance))

CL Item

Veterans Sponsored (Veterans Sponsored)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

General Information

Item Group

General Information

PatientIdentifier

Item

Pt ID# (Local Patient Identifier)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)

PatientLastInitialsName

Item

Last (initial)

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)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)

PatientFirstInitialsName

Item

First (initial)

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)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)

PatientMiddleInitialsName

Item

Middle (initial optional)

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)
C0444598 (UMLS 2011AA Property)

ResponsiblePersonE-mailAddressText

Item

E-mail (for Registration Confirmation)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)

InformedConsentFormSignedDate

Item

Date Informed Consent Signed (month day year)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Item

Was HIPAA Authorization included in Study Informed Consent (mark one)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)

CL.5

Code List

Was HIPAA Authorization included in Study Informed Consent (mark one)

CL Item

Yes: C49488 (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No: C49487 (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientSignedDischargeMedicalRecordDate

Item

HIPAA Authorization Date (If no month day year)

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Eligibility Checklist

Item Group

Eligibility Criteria

HeadofthePancreasNeoplasmLocationInd-2

Item

Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process. NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible. Patients with evidence of Neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible.

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12269 (NCI Thesaurus ObjectClass)
C0227579 (UMLS 2011AA ObjectClass)

CL.6

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SurgicalResectionPancreasPerformedInd-2

Item

Localized, potentially resectable tumors as defined below. All patients must be staged with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following criteria on abdominal imaging: a) No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery b) No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence c) No evidence of visceral or peritoneal metastases NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible. Patients must meet all objective imaging criteria outlined above.

text

C25698 (NCI Thesaurus ObjectClass)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C12393 (NCI Thesaurus Property)
C0030274 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.7

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientAgeInd-2

Item

Age >= 18 years

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)

CL.8

Code List

Age >= 18 years

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Item

ECOG performance status of 0 or 1 (Zubrod)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)

CL.9

Code List

ECOG performance status of 0 or 1 (Zubrod)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status (Zubrod 0 or 1)

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.10

Code List

ECOG Performance Status (Zubrod 0 or 1)

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)

WeightLossAssessmentResponseInd-2

Item

Baseline weight loss <=15% of premorbid weight

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3445 (NCI Thesaurus ObjectClass)
C0043096 (UMLS 2011AA ObjectClass)

CL.11

Code List

Baseline weight loss <=15% of premorbid weight

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2

Item

WBC >= 2,000/mm^3

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

CL.12

Code List

WBC >= 2,000/mm^3

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Item

WBC (>= 2000)

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)

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Item

ANC >= 1,500/mm^3

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

CL.13

Code List

ANC >= 1,500/mm^3

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureNeutrophilResultTotalValue

Item

ANC (>= 1500)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Item

Platelet count >= 100,000/mm^3

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

CL.14

Code List

Platelet count >= 100,000/mm^3

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedurePlateletResultUnspecifiedValue

Item

Platelet count (>= 100000)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTotalBilirubinResultInd-2

Item

Total bilirubin <= 2.5 mg/dL

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)

CL.15

Code List

Total bilirubin <= 2.5 mg/dL

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureTotalBilirubinResultSpecifiedValue

Item

Total Bilirubin (<= 2.5)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Item

Creatinine <= 1.5 mg/dL or a calculated creatinine clearance of >= 50 ml/min (24-hour urine collection)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

CL.16

Code List

Creatinine <= 1.5 mg/dL or a calculated creatinine clearance of >= 50 ml/min (24-hour urine collection)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureCreatinineResultUnspecifiedValue

Item

Creatinine (<= 1.5)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

Item

Calculated creatinine clearance (>= 50)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25498 (NCI Thesaurus ValueDomain)
C0750572 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Item

SGPT (ALT) < 2.5 times ULN

text

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus ObjectClass)
C0376147 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.17

Code List

SGPT (ALT) < 2.5 times ULN

CL Item

Yes (yes)

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

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Item

SGPT (ALT) (< 2.5 times ULN)

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 (ALT) ULN

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)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Item

SGOT (AST) < 2.5 times ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.18

Code List

SGOT (AST) < 2.5 times ULN

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Item

SGOT (AST) (< 2.5 times ULN)

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 (AST) ULN

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)

LaboratoryProcedureAlbuminResultInd-2

Item

Albumin >= 3.2 g/dL

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property)
C0001924 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.19

Code List

Albumin >= 3.2 g/dL

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LaboratoryProcedureAlbuminResultUnspecifiedValue

Item

Albumin (>= 3.2)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property)
C0001924 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

ACOSOGPatientPriorEpidermalGrowthFactorReceptorTreatmentClinicalTrialEligibilityCriteriaInd-2

Item

No history of the following: Prior EGFR targeted therapy or therapy for pancreatic cancer Active infection requiring intravenous antibiotics at the time of registration

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C17068 (NCI Thesaurus Property)
C0034802 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.20

Code List

No history of the following: Prior EGFR targeted therapy or therapy for pancreatic cancer Active infection requiring intravenous antibiotics at the time of registration

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientNegativePregnancyTestIndicator

Item

Non-pregnant and non-breast-feeding (Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic > 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth-control while receiving study therapy. If not a female of child-bearing potential or male check NA)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)

CL.21

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

N/a (N/A)

PatientNegativePregnancyTestDate

Item

Negative urine or serum pregnancy test date (If female of child-bearing potential mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)

PatientNeoplasmPersonalMedicalHistoryInd-2

Item

No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.22

Code List

No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Tillbaka till toppen

ID

Beskrivning

Länk

Nyckelord

Versioner (3)

Uppladdad den

DOI

Licens

Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

Pancreatic Cancer NCT00733746 Registration - Z5041 - OPEN Enrollment Form - 3013792v1.0

No Instruction available.

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning