ID

43458

Beschrijving

GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DA7C30C-FD52-1F06-E040-BB89AD430C14

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DA7C30C-FD52-1F06-E040-BB89AD430C14

Trefwoorden

Versies (4)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Fallopian Tube Cancer NCT01081262 Eligibility - GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) - 3128347v1.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube)
    1. No Instruction available.
Tracking Information
Beschrijving

Tracking Information

GOG Institution Code
Beschrijving

InstitutionGynecologicOncologyGroupIdentifierCode

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
GOG Affiliate Code
Beschrijving

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Datatype

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass-2
C25413
UMLS 2011AA ObjectClass-2
C1510826
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Previous GOG #
Beschrijving

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
Treating physician
Beschrijving

TreatingPhysicianName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Other Physician
Beschrijving

PhysicianPersonVerificationIdentifierName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25741
UMLS 2011AA ObjectClass-2
C0031831
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C45513
UMLS 2011AA Property-2
C1711411
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Patient Hospital No.
Beschrijving

Medical Record Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Date of Birth
Beschrijving

PersonBirthDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Patient Name, Last
Beschrijving

Last Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301584
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
Patient Name, First
Beschrijving

First Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1443235
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
Patient Name, Middle
Beschrijving

PatientMiddleName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Patient Social Security Number
Beschrijving

Social Security Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301821
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25686
Patient Zip Code
Beschrijving

PersonAddressPostalCode

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Country
Beschrijving

AddressCountryText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25464
UMLS 2011AA Property
C0454664
NCI Thesaurus ObjectClass
C25407
UMLS 2011AA ObjectClass
C1442065
Race
Beschrijving

RaceCategoryText

Datatype

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C17049
UMLS 2011AA ObjectClass
C0034510
Ethnicity
Beschrijving

EthnicGroupCategoryText

Datatype

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16564
UMLS 2011AA ObjectClass
C0015031
Method of Payment
Beschrijving

PatientPaymentType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Header
Beschrijving

Header

Did the patient sign an approved informed consent
Beschrijving

InformedConsentFormSignedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Has HIPAA authorization been obtained?
Beschrijving

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
Does the patient have a histologic diagnosis of mucinous adenocarcinoma of the ovary or Fallopian tube
Beschrijving

PersonHistologicOvarianNeoplasmFallopianTubeNeoplasmConfirmedClinicalTrialEligibilityCriteriaInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25526
UMLS 2011AA Property-2
C0205462
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C4984
UMLS 2011AA Property-4
C0919267
NCI Thesaurus Property-5
C3032
UMLS 2011AA Property-5
C0015558
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
What is the site of the disease
Beschrijving

GynecologicMalignantNeoplasmPrimarySite

Datatype

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Does the patient have either Stage II-IV disease (no brain metastasis) or recurrent Stage I disease (chemonaive)?
Beschrijving

PatientGynecologicStageGroupingClinicalTrialEligibilityCriteriaType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C28016
UMLS 2011AA Property-2
C0205480
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C38027
UMLS 2011AA Property-4
C1519504
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
If the patient is newly diagnosed, will protocol therapy begin within 6 weeks of primary debulking?
Beschrijving

PatientNewDiagnosisTimelineEligibilityDeterminationIndicator

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C54576
UMLS 2011AA Property-4
C1705821
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ValueDomain-2
C25521
UMLS 2011AA ValueDomain-2
C1512288
NCI Thesaurus ValueDomain-3
C25171
UMLS 2011AA ValueDomain-3
C0013893
If the patient is stage I (Recurrent), will protocol therapy begin within 14 days of randomization?
Beschrijving

PatientRecurrentDiseaseTimelineEligibilityDeterminationIndicator

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C54576
UMLS 2011AA Property-3
C1705821
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ValueDomain-2
C25521
UMLS 2011AA ValueDomain-2
C1512288
NCI Thesaurus ValueDomain-3
C25171
UMLS 2011AA ValueDomain-3
C0013893
Has the patient had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage?
Beschrijving

PatientRequiredSurgeryEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17173
UMLS 2011AA Property
C0038894
NCI Thesaurus Property-2
C25652
UMLS 2011AA Property-2
C1514873
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does this patient have measurable disease as defined by RECIST 1.1 criteria for assessing clinical response to treatment OR non-measurable disease? (see Section 8.0 in the protocol)
Beschrijving

MeasurableEvaluableDiseasePresentMeasurableEvaluableDiseasePresentType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C37894
UMLS 2011AA ObjectClass-2
C1513040
NCI Thesaurus ObjectClass-3
C8503
UMLS 2011AA ObjectClass-3
C1516986
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Does the patient have measurable disease defined as any tumor lesion that can be accurately measured in at least one dimension with a minimum size of 1.0 cm by CT scan (CT scan slice thickness < 0.5 cm), 1.0 cm caliper measurement by clinical exam, 2.0 cm by chest X-ray, or 1.5 cm malignant, pathologically enlarged lymph node by CT scan?
Beschrijving

MeasurableDiseasePresentIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C37894
UMLS 2011AA ObjectClass-2
C1513040
What method of evaluation is used to obtain tumor measurements?
Beschrijving

Evaluation method

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
What is the size of the largest residual lesion?
Beschrijving

NeoplasmResidualMeasurement

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C37895
UMLS 2011AA Property
C1609982
Has the patient had a negative colonoscopy within one year of today?
Beschrijving

ColonoscopyNegativeFindingInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16450
UMLS 2011AA ObjectClass
C0009378
NCI Thesaurus Property
C38757
UMLS 2011AA Property
C1513916
Unnamed2
Beschrijving

Unnamed2

Date of Results (if more than one, enter earliest)
Beschrijving

LaboratoryProcedureEvaluationOutcomeDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ANC (must be 1,500/mcl or greater)
Beschrijving

ANC

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0948762
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
WBC (must be 3,000 cells/mcl or greater)
Beschrijving

Leukocytes (WBC)

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Platelets (must be 100,000/mcl or greater)
Beschrijving

Platelets

Datatype

float

Maateenheden
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Hemoglobin (Must be greater than or equal to 10 g/dl)
Beschrijving

Hemoglobin

Datatype

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Is Serum Creatinine less than or equal to 1.5 X ULN
Beschrijving

LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the Creatinine Clearance greater than 50 cc/min?
Beschrijving

LaboratoryProcedureCreatinineClearanceEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Is the bilirubin less than or equal to 1.5 X ULN
Beschrijving

LaboratoryProcedureTotalBilirubinResultInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
Are SGOT and Alkaline Phosphatase less than or equal to 2.5 times institutional ULN
Beschrijving

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Are sensory or motor neuropathy less than or equal to CTC Grade 1
Beschrijving

CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C54722
UMLS 2011AA Property
C0205251
NCI Thesaurus Property-2
C4731
UMLS 2011AA Property-2
C0031117
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Does the patient have one of the following: a urine dipstick for proteinuria less then 2+ OR If urine dipstick for proteinuria is greater then 2+, does the 24 hour urine demonstrate less then or equal to 1 g protein in 24 hours OR a urine protein-to-creatinine ratio (UPCR) less then or equal to 1.0 mg/dL?
Beschrijving

PatientProteinUrinalysisEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17241
UMLS 2011AA Property
C0042014
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C17021
UMLS 2011AA Property-3
C0033684
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Are PT and APTT less than or equal to 1.5 X ULN?
Beschrijving

PatientCoagulationBloodInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
CA125 Laboratory upper limit of normal
Beschrijving

LaboratoryProcedureCA-125AntigenTumorMarkerResultUpperLimitofNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C325
UMLS 2011AA Property
C0006610
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17220
UMLS 2011AA Property-3
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Unnamed3
Beschrijving

Unnamed3

Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, Coagulation parameters PT, APTT, CBC, Differential, Platelets, Electrolytes, BUN, Creatinine, Calcium, Magnesium, Phosphorus, UPCR or Urinalysis, Bilirubin, SGOT, Alkaline Phosphatase, Total protein albumin, CA-125)
Beschrijving

LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, EKG, Radiographic tumor Measurement, Chest Imaging and Blood Pressure Measurement)
Beschrijving

PhysicalExaminationPriorTherapeuticProcedurePerformedInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient met the pre-entry requirements as specified in section 7.0
Beschrijving

PatientEligibilityInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Performance Status
Beschrijving

ECOG Performance Status

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Is the patient age 18 years or older
Beschrijving

PatientAgeInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Does the patient have a life expectancy of greater than 3 months?
Beschrijving

PatientLifeExpectancyEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have colon cancer or a history of colon cancer?
Beschrijving

PatientColonMalignantNeoplasmEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12382
UMLS 2011AA Property
C0009368
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have primary peritoneal carcinoma?
Beschrijving

PrimaryPeritonealCarcinomaDiagnosisInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C2916
UMLS 2011AA ObjectClass-2
C0007097
NCI Thesaurus ObjectClass-3
C25313
UMLS 2011AA ObjectClass-3
C0442034
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
If the patient has had a prior invasive malignancy (except non-melanoma skin cancer), has she had any evidence of disease within the last 5 years or does the prior malignancy treatment contraindicate the current protocol therapy
Beschrijving

PatientNeoplasmPersonalMedicalHistoryIndicator

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Has the patient ever received chemotherapy or radiotherapy for any gynecologic or colorectal cancer prior to enrollment?
Beschrijving

PatientPriorGynecologicColorectalChemotherapyRadiationTherapyEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C13363
UMLS 2011AA Property-3
C0555952
NCI Thesaurus Property-4
C25629
UMLS 2011AA Property-4
C0332152
NCI Thesaurus Property-5
C28016
UMLS 2011AA Property-5
C0205480
NCI Thesaurus Property-6
C25171
UMLS 2011AA Property-6
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the treating physician anticipate the need for major surgical procedure during the course of the study? (See Section 3.25)
Beschrijving

GynecologicOncologyGroupMajorSurgeryInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25521
UMLS 2011AA ObjectClass
C1512288
NCI Metathesaurus Property
C0679637
Will the patient have any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of Bevacizumab therapy?
Beschrijving

PriorTreatmentBiopsyAssessmentInd-3b

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C15368
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Has the patient had surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from first cycle of chemotherapy)?
Beschrijving

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property-2
C3671
UMLS 2011AA Property-2
C0043250
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have any evidence of wound disruption or impaired healing?
Beschrijving

RelatedWoundSignificantComplicationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25648
UMLS 2011AA ObjectClass
C0439849
NCI Thesaurus ObjectClass-2
C3671
UMLS 2011AA ObjectClass-2
C0043250
NCI Thesaurus Property
C2959
UMLS 2011AA Property
C0009566
NCI Thesaurus Property-2
C41130
UMLS 2011AA Property-2
C0750502
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of abdominal fistula or perforation within the past 12 months?
Beschrijving

PatientHistoryGIPerforationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C34082
UMLS 2011AA Property
C0017189
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Thesaurus Property-3
C4080
UMLS 2011AA Property-3
C0549099
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a serious non-healing wound, ulcer, or bone fracture? (Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound re-examinations - See Section 7.1 in the protocol.)
Beschrijving

PatientWoundComplicationPersonalMedicalHistoryInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3671
UMLS 2011AA Property
C0043250
NCI Thesaurus Property-2
C2959
UMLS 2011AA Property-2
C0009566
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Beschrijving

PatientHamsterOvaryCellAntibodyHypersensitivityPersonalMedicalHistoryInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12404
UMLS 2011AA Property
C0029939
NCI Thesaurus Property-2
C3114
UMLS 2011AA Property-2
C0020517
NCI Thesaurus Property-3
C12508
UMLS 2011AA Property-3
C0007634
NCI Thesaurus Property-4
C16295
UMLS 2011AA Property-4
C0003241
NCI Thesaurus Property-5
C18772
UMLS 2011AA Property-5
C0262926
NCI Thesaurus Property-6
C14212
UMLS 2011AA Property-6
C0018557
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have mixed epithelial ovarian cancer histology?
Beschrijving

MixedEpithelialOvarianCarcinomaHistologicDiagnosisInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25259
UMLS 2011AA ObjectClass
C0205430
NCI Thesaurus ObjectClass-2
C4908
UMLS 2011AA ObjectClass-2
C0677886
NCI Thesaurus ObjectClass-3
C13315
UMLS 2011AA ObjectClass-3
C0221908
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a tumor of low malignant potential?
Beschrijving

LowPotentialMalignantNeoplasmPresentInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C54722
UMLS 2011AA ObjectClass-2
C0205251
NCI Thesaurus ObjectClass-3
C62230
UMLS 2011AA ObjectClass-3
C0035647
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history or evidence upon physical examination of CNS disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases?
Beschrijving

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-3b

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C3714787
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have uncontrolled hypertension defined as systolic pressure greater than 150mm Hg or diastolic greater than 100mm Hg?
Beschrijving

UncontrolledHypertensionPresentInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
NCI Thesaurus ObjectClass-2
C48932
UMLS 2011AA ObjectClass-2
C0205318
Has the patient had myocardial infarction or unstable angina within 12 months of the first date of Bevacizumab therapy?
Beschrijving

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C27996
UMLS 2011AA ObjectClass
C0027051
NCI Metathesaurus ObjectClass
C0030705
NCI Thesaurus Property
C25627
UMLS 2011AA Property
C0205156
NCI Thesaurus Property-2
C29848
UMLS 2011AA Property-2
C0439234
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Using New York Heart Association (NYHA) guidelines, does the patient have Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication?
Beschrijving

CardiovascularDiseasePresentInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Does the patient have Grade 1, Category 2 or greater, peripheral vascular disease?
Beschrijving

HistoryofPeripheralVascularDiseasePresentInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C66923
UMLS 2011AA ObjectClass
C1881056
Does the patient have a history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of Bevacizumab therapy?
Beschrijving

PatientCerebrovascularAccidentHistoryInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3390
UMLS 2011AA Property
C0038454
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Does the patient have a history of pulmonary embolism or deep vein thrombosis within the past 6 months?
Beschrijving

PatientPulmonaryEmbolismDeepVeinThrombosisEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49343
UMLS 2011AA Property
C0149871
NCI Thesaurus Property-2
C50713
UMLS 2011AA Property-2
C0034065
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of malabsorption or other conditions preventing oral treatment?
Beschrijving

GastrointestinalDiseaseAssessmentIndicator

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C13359
UMLS 2011AA ObjectClass
C0521362
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
If the patient is of childbearing potential will she have a serum pregnancy test within 72 hours of starting protocol therapy and has she agreed to practice an effective form of birth control during study treatment and for six months after completion of treatment?
Beschrijving

PatientNegativePregnancyTestInd-4

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Is the patient pregnant or nursing
Beschrijving

PatientPregnancyInd-3b

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
Beschrijving

PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-4

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-3
C0012634
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus Property-5
C14141
UMLS 2011AA Property-5
C0205191
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?
Beschrijving

PatientHemorrhagePre-ExistingConditionEligibilityInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Metathesaurus Property
CL232826
Is the patient taking warfarin?
Beschrijving

PatientWarfarinTreatmentInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15368
NCI Metathesaurus Property
C0043031
Anticipated date treatment will start
Beschrijving

TreatmentPlannedDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Comments
Beschrijving

Comments

Provide comments about this Fast Fact Sheet
Beschrijving

ClinicalTrialEligibilityCriteriaWorksheetCommentText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
NCI Thesaurus ObjectClass
C16112
UMLS 2011AA ObjectClass
C1516637
NCI Thesaurus Property-2
C73541
UMLS 2011AA Property-2
C2349155
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  1. StudyEvent: GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube)
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Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Tracking Information
InstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Institution Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Affiliate Code
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass-2)
C1510826 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber
Item
Previous GOG #
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)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
PhysicianPersonVerificationIdentifierName
Item
Other Physician
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass-2)
C0031831 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property-2)
C1711411 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
PersonBirthDate
Item
Date of Birth
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)
Last Name
Item
Patient Name, Last
text
C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
First Name
Item
Patient Name, First
text
C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleName
Item
Patient Name, Middle
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Social Security Number
Item
Patient Social Security Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)
PersonAddressPostalCode
Item
Patient 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)
AddressCountryText
Item
Country
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25464 (NCI Thesaurus Property)
C0454664 (UMLS 2011AA Property)
C25407 (NCI Thesaurus ObjectClass)
C1442065 (UMLS 2011AA ObjectClass)
Item
Race
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C17049 (NCI Thesaurus ObjectClass)
C0034510 (UMLS 2011AA ObjectClass)
CL.1
Code List
Race
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 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 Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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 Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
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
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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.3
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
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Sponsored (Veterans Sponsored)
Item Group
Header
InformedConsentFormSignedInd-2
Item
Did the patient sign an approved informed consent
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
Item
Has HIPAA authorization been obtained?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
PersonHistologicOvarianNeoplasmFallopianTubeNeoplasmConfirmedClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient have a histologic diagnosis of mucinous adenocarcinoma of the ovary or Fallopian tube
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C4984 (NCI Thesaurus Property-4)
C0919267 (UMLS 2011AA Property-4)
C3032 (NCI Thesaurus Property-5)
C0015558 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
What is the site of the disease
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.7
Code List
What is the site of the disease
CL Item
Ovary (Ovary)
C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)
CL Item
Fallopian Tube (Fallopian tube)
C12403 (NCI Thesaurus)
C0015560 (UMLS 2011AA)
Item
Does the patient have either Stage II-IV disease (no brain metastasis) or recurrent Stage I disease (chemonaive)?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C28016 (NCI Thesaurus Property-2)
C0205480 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38027 (NCI Thesaurus Property-4)
C1519504 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.8
Code List
Does the patient have either Stage II-IV disease (no brain metastasis) or recurrent Stage I disease (chemonaive)?
CL Item
Stage Ii (Stage II)
CL Item
Stage Iii (Stage III)
CL Item
Stage Iv (Stage IV)
CL Item
Recurrent (Recurrent (chemonaive))
C14173 (NCI Thesaurus)
C2945760 (UMLS 2011AA)
Item
If the patient is newly diagnosed, will protocol therapy begin within 6 weeks of primary debulking?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C54576 (NCI Thesaurus Property-4)
C1705821 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25521 (NCI Thesaurus ValueDomain-2)
C1512288 (UMLS 2011AA ValueDomain-2)
C25171 (NCI Thesaurus ValueDomain-3)
C0013893 (UMLS 2011AA ValueDomain-3)
CL.9
Code List
If the patient is newly diagnosed, will protocol therapy begin within 6 weeks of primary debulking?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Recurrent Disease Not Applicable (Not Applicable - Recurrent disease)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C38155 (NCI Thesaurus-3)
C0277556 (UMLS 2011AA-4)
Item
If the patient is stage I (Recurrent), will protocol therapy begin within 14 days of randomization?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C54576 (NCI Thesaurus Property-3)
C1705821 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25521 (NCI Thesaurus ValueDomain-2)
C1512288 (UMLS 2011AA ValueDomain-2)
C25171 (NCI Thesaurus ValueDomain-3)
C0013893 (UMLS 2011AA ValueDomain-3)
CL.10
Code List
If the patient is stage I (Recurrent), will protocol therapy begin within 14 days of randomization?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Primary Disease Or Disorder Not Applicable (Not Applicable - Primary disease)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C25251 (NCI Thesaurus-3)
C0205225 (UMLS 2011AA-4)
C2991 (NCI Thesaurus-5)
C0012634 (UMLS 2011AA-6)
PatientRequiredSurgeryEligibilityDeterminationInd-2
Item
Has the patient had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17173 (NCI Thesaurus Property)
C0038894 (UMLS 2011AA Property)
C25652 (NCI Thesaurus Property-2)
C1514873 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Does this patient have measurable disease as defined by RECIST 1.1 criteria for assessing clinical response to treatment OR non-measurable disease? (see Section 8.0 in the protocol)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C1513040 (UMLS 2011AA ObjectClass-2)
C8503 (NCI Thesaurus ObjectClass-3)
C1516986 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.12
Code List
Does this patient have measurable disease as defined by RECIST 1.1 criteria for assessing clinical response to treatment OR non-measurable disease? (see Section 8.0 in the protocol)
CL Item
Measurable Disease (Measurable)
C8507 (NCI Thesaurus)
C1513041 (UMLS 2011AA)
CL Item
Non-measurable (Non-measurable)
C25589 (NCI Thesaurus)
C1518373 (UMLS 2011AA)
Item
Does the patient have measurable disease defined as any tumor lesion that can be accurately measured in at least one dimension with a minimum size of 1.0 cm by CT scan (CT scan slice thickness < 0.5 cm), 1.0 cm caliper measurement by clinical exam, 2.0 cm by chest X-ray, or 1.5 cm malignant, pathologically enlarged lymph node by CT scan?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C1513040 (UMLS 2011AA ObjectClass-2)
CL.13
Code List
Does the patient have measurable disease defined as any tumor lesion that can be accurately measured in at least one dimension with a minimum size of 1.0 cm by CT scan (CT scan slice thickness < 0.5 cm), 1.0 cm caliper measurement by clinical exam, 2.0 cm by chest X-ray, or 1.5 cm malignant, pathologically enlarged lymph node by CT scan?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Non-measurable (Not applicable - Non-Measurable)
C25589 (NCI Thesaurus)
C1518373 (UMLS 2011AA)
Item
What method of evaluation is used to obtain tumor measurements?
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.14
Code List
What method of evaluation is used to obtain tumor measurements?
CL Item
Ct Scan (CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Vernier Caliper Measurement Physical Examination (Caliper measurement by clinical exam)
C25209 (NCI Thesaurus)
C0242485 (UMLS 2011AA)
C20989 (NCI Thesaurus-3)
C0031809 (UMLS 2011AA-4)
C81184 (NCI Thesaurus-5)
C2363628 (UMLS 2011AA-6)
CL Item
Chest X-ray (Chest x-ray)
Item
What is the size of the largest residual lesion?
text
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C37895 (NCI Thesaurus Property)
C1609982 (UMLS 2011AA Property)
CL.15
Code List
What is the size of the largest residual lesion?
CL Item
Less Than 0.1 Cm, No Gross Residual Disease (Less than 0.1 cm, no gross residual disease)
CL Item
0.1 - 1.0cm, Optimal Gross Residual Disease (0.1 - 1.0cm, optimal gross residual disease)
CL Item
>1.0 Cm, Suboptimal Gross Residual Disease (>1.0 cm, suboptimal gross residual disease)
ColonoscopyNegativeFindingInd-2
Item
Has the patient had a negative colonoscopy within one year of today?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16450 (NCI Thesaurus ObjectClass)
C0009378 (UMLS 2011AA ObjectClass)
C38757 (NCI Thesaurus Property)
C1513916 (UMLS 2011AA Property)
Item Group
Unnamed2
LaboratoryProcedureEvaluationOutcomeDate
Item
Date of Results (if more than one, enter earliest)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ANC
Item
ANC (must be 1,500/mcl or greater)
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Leukocytes (WBC)
Item
WBC (must be 3,000 cells/mcl or greater)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Platelets (must be 100,000/mcl or greater)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin
Item
Hemoglobin (Must be greater than or equal to 10 g/dl)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2
Item
Is Serum Creatinine less than or equal to 1.5 X ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineClearanceEligibilityDeterminationInd-2
Item
Is the Creatinine Clearance greater than 50 cc/min?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
LaboratoryProcedureTotalBilirubinResultInd-2
Item
Is the bilirubin less than or equal to 1.5 X ULN
boolean
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-2)
C0201913 (UMLS 2011AA Property-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2
Item
Are SGOT and Alkaline Phosphatase less than or equal to 2.5 times institutional ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2
Item
Are sensory or motor neuropathy less than or equal to CTC Grade 1
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C54722 (NCI Thesaurus Property)
C0205251 (UMLS 2011AA Property)
C4731 (NCI Thesaurus Property-2)
C0031117 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
PatientProteinUrinalysisEligibilityDeterminationInd-2
Item
Does the patient have one of the following: a urine dipstick for proteinuria less then 2+ OR If urine dipstick for proteinuria is greater then 2+, does the 24 hour urine demonstrate less then or equal to 1 g protein in 24 hours OR a urine protein-to-creatinine ratio (UPCR) less then or equal to 1.0 mg/dL?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17241 (NCI Thesaurus Property)
C0042014 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C17021 (NCI Thesaurus Property-3)
C0033684 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCoagulationBloodInd-2
Item
Are PT and APTT less than or equal to 1.5 X ULN?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
LaboratoryProcedureCA-125AntigenTumorMarkerResultUpperLimitofNormalValue
Item
CA125 Laboratory upper limit of normal
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Item Group
Unnamed3
LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2
Item
Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, Coagulation parameters PT, APTT, CBC, Differential, Platelets, Electrolytes, BUN, Creatinine, Calcium, Magnesium, Phosphorus, UPCR or Urinalysis, Bilirubin, SGOT, Alkaline Phosphatase, Total protein albumin, CA-125)
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PhysicalExaminationPriorTherapeuticProcedurePerformedInd-2
Item
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, EKG, Radiographic tumor Measurement, Chest Imaging and Blood Pressure Measurement)
boolean
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientEligibilityInd-2
Item
Has the patient met the pre-entry requirements as specified in section 7.0
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.27
Code List
Performance Status
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)
PatientAgeInd-2
Item
Is the patient age 18 years or older
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Does the patient have a life expectancy of greater than 3 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientColonMalignantNeoplasmEligibilityDeterminationInd-2
Item
Does the patient have colon cancer or a history of colon cancer?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12382 (NCI Thesaurus Property)
C0009368 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PrimaryPeritonealCarcinomaDiagnosisInd-2
Item
Does the patient have primary peritoneal carcinoma?
boolean
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2916 (NCI Thesaurus ObjectClass-2)
C0007097 (UMLS 2011AA ObjectClass-2)
C25313 (NCI Thesaurus ObjectClass-3)
C0442034 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNeoplasmPersonalMedicalHistoryIndicator
Item
If the patient has had a prior invasive malignancy (except non-melanoma skin cancer), has she had any evidence of disease within the last 5 years or does the prior malignancy treatment contraindicate the current protocol therapy
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientPriorGynecologicColorectalChemotherapyRadiationTherapyEligibilityDeterminationInd-2
Item
Has the patient ever received chemotherapy or radiotherapy for any gynecologic or colorectal cancer prior to enrollment?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C13363 (NCI Thesaurus Property-3)
C0555952 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C28016 (NCI Thesaurus Property-5)
C0205480 (UMLS 2011AA Property-5)
C25171 (NCI Thesaurus Property-6)
C0013893 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GynecologicOncologyGroupMajorSurgeryInd-2
Item
Does the treating physician anticipate the need for major surgical procedure during the course of the study? (See Section 3.25)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25521 (NCI Thesaurus ObjectClass)
C1512288 (UMLS 2011AA ObjectClass)
C0679637 (NCI Metathesaurus Property)
PriorTreatmentBiopsyAssessmentInd-3b
Item
Will the patient have any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of Bevacizumab therapy?
boolean
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25367 (NCI Thesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2
Item
Has the patient had surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from first cycle of chemotherapy)?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C3671 (NCI Thesaurus Property-2)
C0043250 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RelatedWoundSignificantComplicationInd-2
Item
Does the patient have any evidence of wound disruption or impaired healing?
boolean
C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus ObjectClass-2)
C0043250 (UMLS 2011AA ObjectClass-2)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C41130 (NCI Thesaurus Property-2)
C0750502 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHistoryGIPerforationInd-2
Item
Does the patient have a history of abdominal fistula or perforation within the past 12 months?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C34082 (NCI Thesaurus Property)
C0017189 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C4080 (NCI Thesaurus Property-3)
C0549099 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientWoundComplicationPersonalMedicalHistoryInd-2
Item
Does the patient have a serious non-healing wound, ulcer, or bone fracture? (Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound re-examinations - See Section 7.1 in the protocol.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHamsterOvaryCellAntibodyHypersensitivityPersonalMedicalHistoryInd-2
Item
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12404 (NCI Thesaurus Property)
C0029939 (UMLS 2011AA Property)
C3114 (NCI Thesaurus Property-2)
C0020517 (UMLS 2011AA Property-2)
C12508 (NCI Thesaurus Property-3)
C0007634 (UMLS 2011AA Property-3)
C16295 (NCI Thesaurus Property-4)
C0003241 (UMLS 2011AA Property-4)
C18772 (NCI Thesaurus Property-5)
C0262926 (UMLS 2011AA Property-5)
C14212 (NCI Thesaurus Property-6)
C0018557 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MixedEpithelialOvarianCarcinomaHistologicDiagnosisInd-2
Item
Does the patient have mixed epithelial ovarian cancer histology?
boolean
C25259 (NCI Thesaurus ObjectClass)
C0205430 (UMLS 2011AA ObjectClass)
C4908 (NCI Thesaurus ObjectClass-2)
C0677886 (UMLS 2011AA ObjectClass-2)
C13315 (NCI Thesaurus ObjectClass-3)
C0221908 (UMLS 2011AA ObjectClass-3)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LowPotentialMalignantNeoplasmPresentInd-2
Item
Does the patient have a tumor of low malignant potential?
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C54722 (NCI Thesaurus ObjectClass-2)
C0205251 (UMLS 2011AA ObjectClass-2)
C62230 (NCI Thesaurus ObjectClass-3)
C0035647 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Does the patient have a history or evidence upon physical examination of CNS disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.43
Code List
Does the patient have a history or evidence upon physical examination of CNS disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
UncontrolledHypertensionPresentInd-3
Item
Does the patient have uncontrolled hypertension defined as systolic pressure greater than 150mm Hg or diastolic greater than 100mm Hg?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C48932 (NCI Thesaurus ObjectClass-2)
C0205318 (UMLS 2011AA ObjectClass-2)
MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2
Item
Has the patient had myocardial infarction or unstable angina within 12 months of the first date of Bevacizumab therapy?
boolean
C27996 (NCI Thesaurus ObjectClass)
C0027051 (UMLS 2011AA ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C0205156 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CardiovascularDiseasePresentInd-2
Item
Using New York Heart Association (NYHA) guidelines, does the patient have Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
HistoryofPeripheralVascularDiseasePresentInd-3
Item
Does the patient have Grade 1, Category 2 or greater, peripheral vascular disease?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C66923 (NCI Thesaurus ObjectClass)
C1881056 (UMLS 2011AA ObjectClass)
PatientCerebrovascularAccidentHistoryInd-3
Item
Does the patient have a history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of Bevacizumab therapy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientPulmonaryEmbolismDeepVeinThrombosisEligibilityDeterminationInd-2
Item
Does the patient have a history of pulmonary embolism or deep vein thrombosis within the past 6 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49343 (NCI Thesaurus Property)
C0149871 (UMLS 2011AA Property)
C50713 (NCI Thesaurus Property-2)
C0034065 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GastrointestinalDiseaseAssessmentIndicator
Item
Does the patient have a history of malabsorption or other conditions preventing oral treatment?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Item
If the patient is of childbearing potential will she have a serum pregnancy test within 72 hours of starting protocol therapy and has she agreed to practice an effective form of birth control during study treatment and for six months after completion of treatment?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.51
Code List
If the patient is of childbearing potential will she have a serum pregnancy test within 72 hours of starting protocol therapy and has she agreed to practice an effective form of birth control during study treatment and for six months after completion of treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PatientPregnancyInd-3b
Item
Is the patient pregnant or nursing
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-4
Item
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C14141 (NCI Thesaurus Property-5)
C0205191 (UMLS 2011AA Property-5)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
PatientHemorrhagePre-ExistingConditionEligibilityInd-2
Item
Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
PatientWarfarinTreatmentInd-2
Item
Is the patient taking warfarin?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C0043031 (NCI Metathesaurus Property)
TreatmentPlannedDate
Item
Anticipated date treatment will start
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
ClinicalTrialEligibilityCriteriaWorksheetCommentText
Item
Provide comments about this Fast Fact Sheet
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C16112 (NCI Thesaurus ObjectClass)
C1516637 (UMLS 2011AA ObjectClass)
C73541 (NCI Thesaurus Property-2)
C2349155 (UMLS 2011AA Property-2)
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