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 Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not Reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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)
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 Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
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)
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)
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)
PatientStageIIIStageIVClearCellOvarianMalignantNeoplasmEligibilityDeterminationInd-2
Item
Does the patient have stage III or IV clear cell ovarian cancer with the tumor having at least 50% clear cell histomorphology
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C27970 (NCI Thesaurus Property-2)
C0441771 (UMLS 2011AA Property-2)
C27971 (NCI Thesaurus Property-3)
C0441772 (UMLS 2011AA Property-3)
C12478 (NCI Thesaurus Property-4)
C0229473 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C28047 (NCI Thesaurus Property-6)
C0205065 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPrimaryNeoplasmNegativeFindingWT1ProteinEstrogenReceptorEligibilityDeterminationInd-2
Item
Are there representative stained slides available from the primary tumor showing lack of immunoreactivity or negative for expression of WT-1 antigen and Estrogen Receptor (ER) antigen by immunohistochemistry?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38757 (NCI Thesaurus Property)
C1513916 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C17069 (NCI Thesaurus Property-3)
C0034804 (UMLS 2011AA Property-3)
C8509 (NCI Thesaurus Property-4)
C0677930 (UMLS 2011AA Property-4)
C17549 (NCI Thesaurus Property-5)
C0148873 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
What stage is the disease?
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)
Code List
What stage is the disease?
CL Item
Stage Iii (Stage III)
CL Item
Stage Iv (Stage IV)
PrimaryTumorDiagnosisDate
Item
Date primary confirmed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (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)
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)
PatientAssessmentPostSurgeryTimelineEligibilityDeterminationInd-2
Item
Has it been at least 2 weeks but not more than 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17173 (NCI Thesaurus Property)
C0038894 (UMLS 2011AA Property)
C25217 (NCI Thesaurus Property-2)
C1516048 (UMLS 2011AA Property-2)
C38008 (NCI Thesaurus Property-3)
C0687676 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C54576 (NCI Thesaurus Property-5)
C1705821 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (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)
Item
Is residual disease optimal (<= 1 cm residual disease) or suboptimal?
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C4809 (NCI Thesaurus Property)
C0543478 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Code List
Is residual disease optimal (<= 1 cm residual disease) or suboptimal?
CL Item
Optimal (Optimal)
CL Item
Suboptimal (Suboptimal)
C91065 (NCI Thesaurus)
PatientNoInfectionInd-2
Item
Is the patient free of active infection requiring antibiotics with exception of uncomplicated urinary tract infection (UTI)?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
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 1,000/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)
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 Total Bilirubin within normal institutional limits?
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)
LaboratoryProcedureAspartateAminotransferaseMeasurementAlkalinePhosphataseMeasurementEligibilityDeterminationInd-2
Item
Are the AST (SGOT) and alkaline phosphatase less than or equal to 2.5 times the institutional upper limit of normal?
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64467 (NCI Thesaurus Property)
C0201899 (UMLS 2011AA Property)
C64432 (NCI Thesaurus Property-2)
C0201850 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2
Item
Is creatinine <=1.5 x institutional upper limit of normal, grade 1 per CTCAE Version 4.0?
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)
LaboratoryProcedureCholesterolTriglyceridesEligibilityDeterminationInd-2
Item
Is Cholesterol <=350 mg/dL (fasting) and Triglycerides <=400 mg/dL (fasting)?
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C906 (NCI Thesaurus Property)
C0041004 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C369 (NCI Thesaurus Property-3)
C0008377 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlbuminResultInd-2
Item
Is albumin >=3.0 mg/dL?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
BloodCoagulationAssessmentInd-3b
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 for management of venous thrombosis including pulmonary thrombo-embolus) and the PTT less than 1.2 times the Upper Limit of Normal?
boolean
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)
CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2
Item
Is Neuropathy (sensory or motor) less than or equal to CTCAE 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)
LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2
Item
Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, CBC/Diff/ platelets, Electrolytes Na, K, Cl, BUN, creatinine, Ca, Mg, PO4, Urine Protein Creatinine Ratio, Bilirubin, SGOT, Alkaline Phosphatase, Albumin, Fasting Glucose, Cholesterol, Fasting Triglycerides, PT/PTT/INR, Blood Pressure measurement, DLCO, Serum CA-125 Level)
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 & Physical, Clinical tumor measurement, EKG, Chest imaging X-ray or CT scan of the chest and Radiographic tumor 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
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
text
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)
Code List
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
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No Prior Malignant Neoplasm (No prior malignancy)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C9305 (NCI Thesaurus-3)
C0006826 (UMLS 2011AA-4)
C25629 (NCI Thesaurus-5)
C0332152 (UMLS 2011AA-6)
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 5 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 clear cell ovarian cancer?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
PatientPrimaryPeritoneumFallopianTubeCarcinomaEligibilityDeterminationInd-2
Item
Does the patient have peritoneal or fallopian carcinoma?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C12770 (NCI Thesaurus Property-2)
C0031153 (UMLS 2011AA Property-2)
C12403 (NCI Thesaurus Property-3)
C0015560 (UMLS 2011AA Property-3)
C2916 (NCI Thesaurus Property-4)
C0007097 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientmTORInhibitorPaclitaxelCarboplatinEligibilityDeterminationInd-2
Item
Has the patient had previous treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1282 (NCI Thesaurus Property)
C0079083 (UMLS 2011AA Property)
C1411 (NCI Thesaurus Property-2)
C0144576 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C2201 (NCI Thesaurus Property-4)
C2746052 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CYP3A4 inhibitor or inducer
Item
Is the patient on medications classified as CYP3A4 inducers? (See Appendix II)
boolean
C459 (NCI Thesaurus ObjectClass)
C3830624 (UMLS CUI-1)
C61367 (NCI Thesaurus ObjectClass-2)
C3830625 (UMLS CUI-2)
C17573 (NCI Thesaurus ObjectClass-3)
C42791 (NCI Thesaurus ObjectClass-4)
C25409 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
PatientTemsirolimusLowerMedicationEligibilityDeterminationInd-2
Item
Is the patient receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) or any other CYP3A4 inducer such as rifampin or St. John's Wort, as these may decrease temsirolimus levels?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus Property)
C0013227 (UMLS 2011AA Property)
C86568 (NCI Thesaurus Property-2)
C2003888 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C1844 (NCI Thesaurus Property-4)
C0796512 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientStrongCytochromeP4503A4InductionMedicationEligibilityDeterminationInd-2
Item
Is the patient receiving any Strong CYP3A4 inhibitors? (See Appendix II)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus Property)
C0013227 (UMLS 2011AA Property)
C61367 (NCI Thesaurus Property-2)
C0205263 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C17573 (NCI Thesaurus Property-4)
C1142644 (UMLS 2011AA Property-4)
C62223 (NCI Thesaurus Property-5)
C0442821 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
Item
Is the patient receiving any investigational agents?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C1517586 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-5)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientSevereImpairmentLungCapacityEligibilityDeterminationInd-2
Item
Does the patient have severely impaired lung function defined as a diffusion lung capacity for carbon monoxide (DLCO) <= 50% of the normal predicted value and/or O2 saturation <= 88% at rest on room air?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C70667 (NCI Thesaurus Property-2)
C0205082 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C21055 (NCI Thesaurus Property-4)
C0684336 (UMLS 2011AA Property-4)
C25443 (NCI Thesaurus Property-5)
C1516240 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CardiovascularDiseasePresentInd-2
Item
Does the patient have a history with symptomatic congestive heart failure of New York Heart Association Class III or IV (See Appendix III), unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction <=6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant disease?
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)
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)
PatientBaselineOxygenRequirementEligibilityDeterminationInd-2
Item
Does the patient have a baseline requirement for oxygen?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C722 (NCI Thesaurus Property)
C0030054 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C38015 (NCI Thesaurus Property-3)
C0168634 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ConcomitantMedicationCorticosteroidAdministeredInd-2
Item
Is the patient on maintenance corticosteriods? (Any treatment longer than 5 days.)
boolean
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C2322 (NCI Thesaurus Property)
C0001617 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientSeriousConcomitantDiseaseorDisorderEligibilityDeterminationInd-2
Item
Does the patient have a serious concomitant illness which, in the opinion of the treating physician, will place patient at unreasonable risk from therapy on this protocol?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C54035 (NCI Thesaurus Property-3)
C0205404 (UMLS 2011AA Property-3)
C25730 (NCI Thesaurus Property-4)
C0521115 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
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)
PatientLesserControlDiabetesMellitusEligibilityDeterminationInd-2
Item
Does the patient have poorly controlled diabetes?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property-2)
C2587213 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C61422 (NCI Thesaurus Property-4)
C0547044 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)