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  1. StudyEvent: GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal)
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Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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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