ID

43468

Beschreibung

GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal) Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=893B4E4E-209D-97F3-E040-BB89AD4371DB

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=893B4E4E-209D-97F3-E040-BB89AD4371DB

Stichworte

Versionen (5)
  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. 09.01.15 09.01.15 - Martin Dugas
  5. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Fallopian Tube Cancer NCT01167712 Pre-Study - GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal) - 3110638v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal)
    1. No Instruction available.
Tracking Information
Beschreibung

Tracking Information

GOG Institution Code
Beschreibung

InstitutionGynecologicOncologyGroupIdentifierCode

Datentyp

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
Beschreibung

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Datentyp

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 #
Beschreibung

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Datentyp

text

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

TreatingPhysicianName

Datentyp

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
Beschreibung

PhysicianPersonVerificationIdentifierName

Datentyp

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.
Beschreibung

Medical Record Number

Datentyp

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
Beschreibung

PersonBirthDate

Datentyp

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
Beschreibung

Last Name

Datentyp

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
Beschreibung

First Name

Datentyp

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
Beschreibung

PatientMiddleName

Datentyp

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
Beschreibung

Social Security Number

Datentyp

text

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

PersonAddressPostalCode

Datentyp

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
Beschreibung

AddressCountryText

Datentyp

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
Beschreibung

RaceCategoryText

Datentyp

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
Beschreibung

EthnicGroupCategoryText

Datentyp

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
Beschreibung

PatientPaymentType

Datentyp

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
Beschreibung

Header

Did the patient sign an approved informed consent
Beschreibung

InformedConsentFormSignedInd-2

Datentyp

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?
Beschreibung

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Datentyp

text

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
What is the site of the disease
Beschreibung

GynecologicMalignantNeoplasmPrimarySite

Datentyp

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
What is the stage/residual disease status
Beschreibung

PatientGynecologicStageGroupingClinicalTrialEligibilityCriteriaType

Datentyp

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 Stage IV, how was the stage documented
Beschreibung

AssessmentStageIVMethodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus Property-2
C27971
UMLS 2011AA Property-2
C0441772
Is the patient eligible for a higher priority GOG protocol (for example GOG-0252)
Beschreibung

PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25521
UMLS 2011AA Property
C1512288
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C48911
UMLS 2011AA Property-3
C0549179
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
What was the grade of the primary tumor
Beschreibung

GynecologicTumorHistologicGrade

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain-2
C18000
UMLS 2011AA ValueDomain-2
C0919553
Does this patient have measurable disease as defined by RECIST criteria for assessing clinical response to treatment OR non-measurable disease (see Section 8.0 in the protocol)
Beschreibung

MeasurableEvaluableDiseasePresentMeasurableEvaluableDiseasePresentType

Datentyp

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
What is the cell type
Beschreibung

GynecologicTumorHistologicCategory

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Does the patient have a current diagnosis of borderline epithelial ovarian tumor or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only
Beschreibung

OvaryPeritoneumFallopianTubeMalignantNeoplasmSurgicalProcedureInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C12404
UMLS 2011AA ObjectClass
C0029939
NCI Thesaurus ObjectClass-2
C12770
UMLS 2011AA ObjectClass-2
C0031153
NCI Thesaurus ObjectClass-3
C12403
UMLS 2011AA ObjectClass-3
C0015560
NCI Thesaurus ObjectClass-4
C9305
UMLS 2011AA ObjectClass-4
C0006826
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient going to receive neo-adjuvant chemotherapy with interval cytoreductive surgery
Beschreibung

GynecologicNeoadjuvantTherapyChemotherapyAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus ObjectClass-3
C28016
UMLS 2011AA ObjectClass-3
C0205480
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the required core biopsy done
Beschreibung

SurgicalProcedureCoreBiopsyPerformedInd-3b

Datentyp

text

Alias
NCI Thesaurus Property
C15680
UMLS 2011AA Property
C1318309
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
If done, what was the date the core biopsy was done
Beschreibung

SurgicalProcedureCoreBiopsyPerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C15680
UMLS 2011AA Property
C1318309
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
Does the patient have documentation of at least stage II disease acquired via imaging or surgery (without attempt at cytoreduction)
Beschreibung

StageIIOvarianCancerDiagnosisInd-3b

Datentyp

text

Alias
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ObjectClass
C7830
UMLS 2011AA ObjectClass
C0278686
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Has the patient had abdominal surgery with appropriate tissue available for histologic evaluation and maximum tumor debulking
Beschreibung

DebulkingPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15749
UMLS 2011AA ObjectClass
C0439805
If surgery done, what is the date of surgery
Beschreibung

DebulkingPerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15749
UMLS 2011AA ObjectClass
C0439805
Has the patient had another invasive malignancy (other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin) diagnosed, present or recur within the past 5 years
Beschreibung

PatientNeoplasmPersonalMedicalHistoryIndicator

Datentyp

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 received prior radiotherapy to any portion of the abdominal cavity or pelvis (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease )
Beschreibung

PriorRTPelvicAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25399
UMLS 2011AA Property
C0030797
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Has the patient received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or Fallopian tube cancer (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
Beschreibung

PriorGynecologicChemotherapyAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C28016
UMLS 2011AA ObjectClass-3
C0205480
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had previous cancer treatment which contraindicates this protocol therapy
Beschreibung

ReceivedTherapyProtocolContraindicatedInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25639
UMLS 2011AA ObjectClass
C1514756
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C37933
UMLS 2011AA Property-2
C1444657
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If the patient has a synchronous primary endometrial cancer or past history of endometrial cancer, is it more advanced than Stage I-B OR with greater than superficial myometrial invasion with vascular or lymphatic invasion OR poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade 3 lesions
Beschreibung

PatientEndometrialMalignantNeoplasmEligibilityDeterminationInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C13322
UMLS 2011AA Property-3
C0227843
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Has the patient received any targeted therapy (including, but not limited to vaccines, antibodies or tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, Fallopian tube or peritoneal primary carcinoma
Beschreibung

PatientEndometrialMalignantNeoplasmTreatmentEligibilityDeterminationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C15368
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-4
C13322
UMLS 2011AA Property-3
C0227843
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Performance Status
Beschreibung

ECOG Performance Status

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Unnamed2
Beschreibung

Unnamed2

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

LaboratoryProcedureEvaluationOutcomeDate

Datentyp

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 and not induced or supported by GCSFs)
Beschreibung

ANC

Datentyp

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
Platelets (must be 100,000/mcl or greater)
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 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
Is the bilirubin less than or equal to 1.5 X ULN
Beschreibung

LaboratoryProcedureTotalBilirubinResultInd-2

Datentyp

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
Is the SGOT less than or equal to 3 X ULN
Beschreibung

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Datentyp

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
Is the alkaline phosphatase less than or equal to 2.5 X ULN
Beschreibung

LaboratoryProcedureAlkalinePhosphataseUpperLimitofNormalOutcomeInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
NCI Thesaurus Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is Serum Creatinine less than or equal to 1.5 X ULN
Beschreibung

LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2

Datentyp

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
Are sensory or motor neuropathy less than or equal to CTC Grade 1
Beschreibung

CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2

Datentyp

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
Unnamed3
Beschreibung

Unnamed3

Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (CBC, Differential, Platelets, Serum Creatinine, Bilirubin, SGOT, Alkaline Phosphatase, Calcium, Phosphorus, Magnesium, Urinalysis, Toxicity Assessment, Serum Pregnancy test if childbearing potential exists)
Beschreibung

LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2

Datentyp

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, CA-125, Chest X-Ray, EKG and Radiographic Disease Assessment)
Beschreibung

PhysicalExaminationPriorTherapeuticProcedurePerformedInd-2

Datentyp

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
If the patient has a history of hearing loss, has an audiogram been performed
Beschreibung

HearingAssessmentCompleteInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass-2
C16670
UMLS 2011AA ObjectClass-2
C0018767
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
Beschreibung

PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-4

Datentyp

text

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
Has the patient had a myocardial infarction, unstable angina or a history of CVA within the last six months
Beschreibung

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Datentyp

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
Does the patient have New York Heart Association Grade II or greater congestive heart failure
Beschreibung

CardiovascularDiseasePresentInd-2

Datentyp

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 serious cardiac arrhythmia requiring medication (This does not include asymptomatic, atrial fibrillation with controlled ventricular rate)
Beschreibung

ArrhythmiaPresentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2881
UMLS 2011AA ObjectClass
C0003811
Is the patient pregnant or breastfeeding
Beschreibung

PatientPregnancyInd-3b

Datentyp

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
Is the patient age 18 years or older
Beschreibung

PatientAgeInd-2

Datentyp

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
Has the patient received prior therapy with any anti-VEGF drug, including Bevacizumab
Beschreibung

PriorVascularEndothelialGrowthFactorAntibodyTherapyReceivedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C16295
UMLS 2011AA ObjectClass-2
C0003241
NCI Thesaurus ObjectClass-4
C20450
UMLS 2011AA ObjectClass-3
C0078058
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a medical history or condition not otherwise previously specified which in the opinion of the investigator should exclude her from participating in this study
Beschreibung

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Eligibility 4
Beschreibung

Eligibility 4

Has the patient elected to receive concurrent or consolidation bevacizumab?
Beschreibung

BevacizumabAgentAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2039
UMLS 2011AA ObjectClass
C0796392
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Has the pre-treatment blood pressure been recorded
Beschreibung

PriorTreatmentBloodPressureAssessmentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C54706
UMLS 2011AA ObjectClass-2
C0005823
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Are the pre-treatment Urine Protein-Creatine Ratio (UPCR) results available
Beschreibung

PriorTherapyUrineProteinCreatinineAssessmentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C15368
NCI Thesaurus ObjectClass-4
C17021
UMLS 2011AA ObjectClass-3
C0033684
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Is the urine protein-creatinine ratio (UPCR) less than 1.0
Beschreibung

UrinaryCreatinineProteinAssessmentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25711
UMLS 2011AA ObjectClass
C1524119
NCI Thesaurus ObjectClass-2
C17021
UMLS 2011AA ObjectClass-2
C0033684
NCI Metathesaurus ObjectClass
C0010294
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Are the pre-treatment PT/PT INR/PTT results available
Beschreibung

PriorTherapyProthrombinTimeInternationalNormalizedRatioofProthrombinTimeAssessmentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C62656
UMLS 2011AA ObjectClass-2
C0033707
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C64805
UMLS 2011AA Property
C0525032
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Is the PT INR less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and the PTT less than 1.2 times the Upper Limit of Normal
Beschreibung

BloodCoagulationAssessmentInd-3b

Datentyp

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20812
UMLS 2011AA ObjectClass
C0005778
NCI Thesaurus ObjectClass-2
C12434
UMLS 2011AA ObjectClass-2
C0229664
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy: Blood Pressure
Beschreibung

LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-3b

Datentyp

text

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
C49797
UMLS 2011AA ValueDomain
C1708496
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?
Beschreibung

PatientHemorrhagePre-ExistingConditionInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Metathesaurus Property
CL232826
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have a serious non-healing wound, ulcer or bone fracture? (This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. 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.)
Beschreibung

PatientWoundComplicationPersonalMedicalHistoryInd-3b

Datentyp

text

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
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study?
Beschreibung

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-3b

Datentyp

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 CTCAE Grade 2 or greater peripheral vascular disease
Beschreibung

HistoryofPeripheralVascularDiseasePresentInd-3b

Datentyp

text

Alias
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C66923
UMLS 2011AA ObjectClass
C1881056
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies or a known allergy to cremophor or Polysorbate 80?
Beschreibung

PatientHamsterOvaryCellAntibodyHypersensitivityPersonalMedicalHistoryInd-3b

Datentyp

text

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
C49797
UMLS 2011AA ValueDomain
C1708496
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of treatment start date of Bevacizumab therapy (cycle 2)?
Beschreibung

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-3b

Datentyp

text

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
C49797
UMLS 2011AA ValueDomain
C1708496
Is a major surgical procedure anticipated for this patient during the course of this study
Beschreibung

GynecologicOncologyGroupMajorSurgeryInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25521
UMLS 2011AA ObjectClass
C1512288
NCI Metathesaurus Property
C0679637
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Will the patient have any tissue biopsy, such as a core biopsy, within 7 days prior to treatment start date of Bevacizumab therapy (cycle 2)?
Beschreibung

PriorTreatmentBiopsyAssessmentInd-3b

Datentyp

text

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
Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration or nutrition?
Beschreibung

GastrointestinalObstructionSymptomInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C13359
UMLS 2011AA ObjectClass
C0521362
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus ObjectClass-2
C3284
UMLS 2011AA ObjectClass-2
C0028778
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patient at high risk of lethal hemorrhage during treatment with Bevacizumab (i.e. hemoptysis, liver rupture)?
Beschreibung

ParenchymaLiverLungMetastasisPresentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus ObjectClass-2
C12392
UMLS 2011AA ObjectClass-2
C0023884
NCI Thesaurus ObjectClass-3
C19151
UMLS 2011AA ObjectClass-3
C0027627
NCI Thesaurus ObjectClass-4
C74601
UMLS 2011AA ObjectClass-4
C0933845
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
If patient is of childbearing potential, has she agreed to use contraceptive measures during study therapy and for at least 6 months after completion of Bevacizumab therapy
Beschreibung

ContraceptionAgreementInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C37932
UMLS 2011AA ObjectClass
C0700589
NCI Thesaurus Property
C25369
UMLS 2011AA Property
C0680240
Has the pre-treatment incision check been completed?
Beschreibung

PriorTherapySurgicalIncisionAssessmentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15384
UMLS 2011AA ObjectClass-2
C0184898
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Is your site accredited to participate in the imaging component of this study, ACRIN 6695
Beschreibung

PersonAncillaryStudyRegistrationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C16041
UMLS 2011AA Property-2
C1515980
If your site is accredited, did the patient consent to participate in the imaging component of this study, ACRIN 6695
Beschreibung

ParticipatingPatientAncillaryStudyConsentInd-3b

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25608
UMLS 2011AA ObjectClass-2
C0679823
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Metathesaurus Property
CL004903
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Anticipated date treatment will start
Beschreibung

TreatmentPlannedDate

Datentyp

date

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

Comments

Provide comments about this Fast Fact Sheet
Beschreibung

ClinicalTrialEligibilityCriteriaWorksheetCommentText

Datentyp

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-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
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)
Item
Has HIPAA authorization been obtained?
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
Has HIPAA authorization been obtained?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Exempt - Non-usa Participant (Exempt - non-USA participant)
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.6
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)
CL Item
Peritoneum (Peritoneum)
C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)
Item
What is the stage/residual disease status
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.7
Code List
What is the stage/residual disease status
CL Item
Stage Ii (Stage II)
CL Item
Stage Iii Less Than Or Equal To 1.0cm (Stage III less than or equal to 1.0cm)
CL Item
Residual Disease Or Disorder Stage Iii (Stage III, Max Residual disease > 1cm)
C2991 (NCI Thesaurus)
C0012634 (UMLS 2011AA)
C27970 (NCI Thesaurus-3)
C0441771 (UMLS 2011AA-4)
C37895 (NCI Thesaurus-5)
C1609982 (UMLS 2011AA-6)
C2991 (NCI Thesaurus-7)
C0012634 (UMLS 2011AA-8)
C27970 (NCI Thesaurus-9)
C0441771 (UMLS 2011AA-10)
C37895 (NCI Thesaurus-11)
C1609982 (UMLS 2011AA-12)
CL Item
Stage Iii (neo-adjuvant Therapy Planned) (Stage III (Neo-Adjuvant therapy planned))
CL Item
Stage Iv (Stage IV)
Item
If Stage IV, how was the stage documented
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C27971 (NCI Thesaurus Property-2)
C0441772 (UMLS 2011AA Property-2)
CL.8
Code List
If Stage IV, how was the stage documented
CL Item
Histologic (Histological)
C25526 (NCI Thesaurus)
C0205462 (UMLS 2011AA)
C25526 (NCI Thesaurus-3)
C0205462 (UMLS 2011AA-4)
CL Item
Non-histological Method (Non-Histological Method)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2
Item
Is the patient eligible for a higher priority GOG protocol (for example GOG-0252)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C48911 (NCI Thesaurus Property-3)
C0549179 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
What was the grade of the primary tumor
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)
CL.10
Code List
What was the grade of the primary tumor
CL Item
Not Graded (Not Graded)
CL Item
Grade 1-well Differentiated (1)
CL Item
Grade 2-moderately Differentiated (2)
CL Item
Grade 3-poorly Differentiated (3)
Item
Does this patient have measurable disease as defined by RECIST 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.11
Code List
Does this patient have measurable disease as defined by RECIST 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
What is the cell type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.12
Code List
What is the cell type
CL Item
Not Otherwise Specified Adenocarcinoma (Adenocarcinoma, NOS)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C19594 (NCI Thesaurus-3)
C1518425 (UMLS 2011AA-4)
CL Item
Clear Cell Carcinoma (Clear cell carcinoma)
CL Item
Endometrioid Adenocarcinoma (Endometrioid adenocarcinoma)
C3769 (NCI Thesaurus)
C0206687 (UMLS 2011AA)
CL Item
Malignant Ovarian Brenner Tumor (Malignant Brenner's tumor)
C4270 (NCI Thesaurus)
C0334495 (UMLS 2011AA)
CL Item
Mixed Epithelial Carcinoma, Specify Components (Mixed epithelial carcinoma)
CL Item
Mucinous Adenocarcinoma (Mucinous adenocarcinoma)
C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)
CL Item
Serous Adenocarcinoma (Serous adenocarcinoma)
C40101 (NCI Thesaurus)
C0206701 (UMLS 2011AA)
CL Item
Transitional Cell Carcinoma (Transitional Cell Carcinoma)
C2930 (NCI Thesaurus)
C0007138 (UMLS 2011AA)
CL Item
Undifferentiated Carcinoma (Undifferentiated carcinoma)
C3692 (NCI Thesaurus)
C0205698 (UMLS 2011AA)
OvaryPeritoneumFallopianTubeMalignantNeoplasmSurgicalProcedureInd-2
Item
Does the patient have a current diagnosis of borderline epithelial ovarian tumor or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only
boolean
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C12770 (NCI Thesaurus ObjectClass-2)
C0031153 (UMLS 2011AA ObjectClass-2)
C12403 (NCI Thesaurus ObjectClass-3)
C0015560 (UMLS 2011AA ObjectClass-3)
C9305 (NCI Thesaurus ObjectClass-4)
C0006826 (UMLS 2011AA ObjectClass-4)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GynecologicNeoadjuvantTherapyChemotherapyAdministeredInd-2
Item
Is the patient going to receive neo-adjuvant chemotherapy with interval cytoreductive surgery
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C28016 (NCI Thesaurus ObjectClass-3)
C0205480 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Was the required core biopsy done
text
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.15
Code List
Was the required core biopsy done
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)
SurgicalProcedureCoreBiopsyPerformedDate
Item
If done, what was the date the core biopsy was done
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
Item
Does the patient have documentation of at least stage II disease acquired via imaging or surgery (without attempt at cytoreduction)
text
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C7830 (NCI Thesaurus ObjectClass)
C0278686 (UMLS 2011AA ObjectClass)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.16
Code List
Does the patient have documentation of at least stage II disease acquired via imaging or surgery (without attempt at cytoreduction)
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)
DebulkingPerformedInd-2
Item
Has the patient had abdominal surgery with appropriate tissue available for histologic evaluation and maximum tumor debulking
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15749 (NCI Thesaurus ObjectClass)
C0439805 (UMLS 2011AA ObjectClass)
DebulkingPerformedDate
Item
If surgery done, what is the date of surgery
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15749 (NCI Thesaurus ObjectClass)
C0439805 (UMLS 2011AA ObjectClass)
PatientNeoplasmPersonalMedicalHistoryIndicator
Item
Has the patient had another invasive malignancy (other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin) diagnosed, present or recur within the past 5 years
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)
PriorRTPelvicAdministeredInd-3
Item
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease )
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25399 (NCI Thesaurus Property)
C0030797 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PriorGynecologicChemotherapyAdministeredInd-2
Item
Has the patient received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or Fallopian tube cancer (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C28016 (NCI Thesaurus ObjectClass-3)
C0205480 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ReceivedTherapyProtocolContraindicatedInd-3
Item
Has the patient had previous cancer treatment which contraindicates this protocol therapy
boolean
C25639 (NCI Thesaurus ObjectClass)
C1514756 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property-2)
C1444657 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
If the patient has a synchronous primary endometrial cancer or past history of endometrial cancer, is it more advanced than Stage I-B OR with greater than superficial myometrial invasion with vascular or lymphatic invasion OR poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade 3 lesions
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-3)
C0227843 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.22
Code List
If the patient has a synchronous primary endometrial cancer or past history of endometrial cancer, is it more advanced than Stage I-B OR with greater than superficial myometrial invasion with vascular or lymphatic invasion OR poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade 3 lesions
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)
PatientEndometrialMalignantNeoplasmTreatmentEligibilityDeterminationInd-2
Item
Has the patient received any targeted therapy (including, but not limited to vaccines, antibodies or tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, Fallopian tube or peritoneal primary carcinoma
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-4)
C0227843 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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.24
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)
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 and not induced or supported by GCSFs)
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)
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)
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
Is the SGOT less than or equal to 3 X 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)
LaboratoryProcedureAlkalinePhosphataseUpperLimitofNormalOutcomeInd-2
Item
Is the alkaline phosphatase less than or equal to 2.5 X ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA 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)
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)
Item Group
Unnamed3
LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2
Item
Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (CBC, Differential, Platelets, Serum Creatinine, Bilirubin, SGOT, Alkaline Phosphatase, Calcium, Phosphorus, Magnesium, Urinalysis, Toxicity Assessment, Serum Pregnancy test if childbearing potential exists)
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, CA-125, Chest X-Ray, EKG and Radiographic Disease Assessment)
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)
Item
If the patient has a history of hearing loss, has an audiogram been performed
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C16670 (NCI Thesaurus ObjectClass-2)
C0018767 (UMLS 2011AA ObjectClass-2)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.32
Code List
If the patient has a history of hearing loss, has an audiogram been performed
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)
Item
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
text
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)
CL.33
Code List
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
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)
MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2
Item
Has the patient had a myocardial infarction, unstable angina or a history of CVA within the last six months
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
Does the patient have New York Heart Association Grade II or greater congestive heart failure
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)
ArrhythmiaPresentInd-2
Item
Does the patient have serious cardiac arrhythmia requiring medication (This does not include asymptomatic, atrial fibrillation with controlled ventricular rate)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
PatientPregnancyInd-3b
Item
Is the patient pregnant or breastfeeding
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)
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)
PriorVascularEndothelialGrowthFactorAntibodyTherapyReceivedInd-2
Item
Has the patient received prior therapy with any anti-VEGF drug, including Bevacizumab
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C16295 (NCI Thesaurus ObjectClass-3)
C0003241 (UMLS 2011AA ObjectClass-2)
C20450 (NCI Thesaurus ObjectClass-4)
C0078058 (UMLS 2011AA ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
Item
Does the patient have a medical history or condition not otherwise previously specified which in the opinion of the investigator should exclude her from participating in this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Eligibility 4
BevacizumabAgentAdministeredInd-2
Item
Has the patient elected to receive concurrent or consolidation bevacizumab?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2039 (NCI Thesaurus ObjectClass)
C0796392 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Has the pre-treatment blood pressure been recorded
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C54706 (NCI Thesaurus ObjectClass-3)
C0005823 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.42
Code List
Has the pre-treatment blood pressure been recorded
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)
Item
Are the pre-treatment Urine Protein-Creatine Ratio (UPCR) results available
text
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C17021 (NCI Thesaurus ObjectClass-4)
C0033684 (UMLS 2011AA ObjectClass-3)
C25367 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.43
Code List
Are the pre-treatment Urine Protein-Creatine Ratio (UPCR) results available
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)
Item
Is the urine protein-creatinine ratio (UPCR) less than 1.0
text
C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.44
Code List
Is the urine protein-creatinine ratio (UPCR) less than 1.0
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)
Item
Are the pre-treatment PT/PT INR/PTT results available
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C62656 (NCI Thesaurus ObjectClass-3)
C0033707 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C64805 (NCI Thesaurus Property-2)
C0525032 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.45
Code List
Are the pre-treatment PT/PT INR/PTT results available
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)
Item
Is the PT INR less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and the PTT less than 1.2 times the Upper Limit of Normal
text
C25367 (NCI Thesaurus Property)
C20812 (NCI Thesaurus ObjectClass)
C0005778 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C0229664 (UMLS 2011AA ObjectClass-2)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.46
Code List
Is the PT INR less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and the PTT less than 1.2 times the Upper Limit of Normal
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)
Item
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy: Blood Pressure
text
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)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.47
Code List
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy: Blood Pressure
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)
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?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.48
Code List
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?
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)
Item
Does the patient have a serious non-healing wound, ulcer or bone fracture? (This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. 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.)
text
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)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.49
Code List
Does the patient have a serious non-healing wound, ulcer or bone fracture? (This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. 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.)
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)
Item
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study?
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.50
Code List
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study?
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)
Item
Does the patient have CTCAE Grade 2 or greater peripheral vascular disease
text
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C66923 (NCI Thesaurus ObjectClass)
C1881056 (UMLS 2011AA ObjectClass)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.51
Code List
Does the patient have CTCAE Grade 2 or greater peripheral vascular disease
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)
Item
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies or a known allergy to cremophor or Polysorbate 80?
text
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)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.52
Code List
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies or a known allergy to cremophor or Polysorbate 80?
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)
Item
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of treatment start date of Bevacizumab therapy (cycle 2)?
text
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)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.53
Code List
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of treatment start date of Bevacizumab therapy (cycle 2)?
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)
Item
Is a major surgical procedure anticipated for this patient during the course of this study
text
C25521 (NCI Thesaurus ObjectClass)
C1512288 (UMLS 2011AA ObjectClass)
C0679637 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.54
Code List
Is a major surgical procedure anticipated for this patient during the course of this study
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)
Item
Will the patient have any tissue biopsy, such as a core biopsy, within 7 days prior to treatment start date of Bevacizumab therapy (cycle 2)?
text
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)
CL.55
Code List
Will the patient have any tissue biopsy, such as a core biopsy, within 7 days prior to treatment start date of Bevacizumab therapy (cycle 2)?
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)
Item
Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration or nutrition?
text
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C3284 (NCI Thesaurus ObjectClass-2)
C0028778 (UMLS 2011AA ObjectClass-2)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.56
Code List
Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration or nutrition?
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)
Item
Does the patient have metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patient at high risk of lethal hemorrhage during treatment with Bevacizumab (i.e. hemoptysis, liver rupture)?
text
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass-2)
C19151 (NCI Thesaurus ObjectClass-3)
C0027627 (UMLS 2011AA ObjectClass-3)
C74601 (NCI Thesaurus ObjectClass-4)
C0933845 (UMLS 2011AA ObjectClass-4)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.57
Code List
Does the patient have metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patient at high risk of lethal hemorrhage during treatment with Bevacizumab (i.e. hemoptysis, liver rupture)?
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)
Item
If patient is of childbearing potential, has she agreed to use contraceptive measures during study therapy and for at least 6 months after completion of Bevacizumab therapy
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
CL.58
Code List
If patient is of childbearing potential, has she agreed to use contraceptive measures during study therapy and for at least 6 months after completion of Bevacizumab therapy
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)
Item
Has the pre-treatment incision check been completed?
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15384 (NCI Thesaurus ObjectClass-3)
C0184898 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.59
Code List
Has the pre-treatment incision check been completed?
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)
PersonAncillaryStudyRegistrationInd-2
Item
Is your site accredited to participate in the imaging component of this study, ACRIN 6695
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C16041 (NCI Thesaurus Property-2)
C1515980 (UMLS 2011AA Property-2)
Item
If your site is accredited, did the patient consent to participate in the imaging component of this study, ACRIN 6695
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus ObjectClass-2)
C0679823 (UMLS 2011AA ObjectClass-2)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL004903 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.61
Code List
If your site is accredited, did the patient consent to participate in the imaging component of this study, ACRIN 6695
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)
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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