The aim of the "Initial Evaluation (Form 1)" Folder is to collect information at the time of randomization and prior to start of protocol therapy. The "Initial Evaluation (Form 1)" Folder should be completed by 2 weeks after start of protocol therapy and submitted electronically.

1 formularios

StudyEvent: NCIC OV 21 Initial Evaluation Form
1. The aim of the "Initial Evaluation (Form 1)" Folder is to collect information at the time of randomization and prior to start of protocol therapy. The "Initial Evaluation (Form 1)" Folder should be completed by 2 weeks after start of protocol therapy and submitted electronically.

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Patient Information

Item Group

Patient Information

PatientNationalCancerInstituteofCanadaIdentifierNumber

Item

NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25582 (NCI Thesaurus Property-2)
C1513884 (UMLS 2011AA Property-2)

Patient Initials

Item

Patient Initials (first-middle-last)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Medical Record Number

Item

Patient Hospital No. (if permitted by REB)

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

PhysicianInvestigatorIdentifierNumber

Item

Investigator No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)

InvestigatorFirstName

Item

Investigator First Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

TreatingPhysicianMiddleName

Item

Investigator Middle Name

text

C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

InvestigatorLastName

Item

Investigator Last Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)

Patient Race/Ethnicity

Item Group

Patient Race/ethnicity

Racial Group

Item

Patient Race (please check all that apply; the patient is encouraged to self designate)

text

C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)

CL.1

Code List

Patient Race (please check all that apply; the patient is encouraged to self designate)

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

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

C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)

CL Item

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

C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of 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 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

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)

Ethnic Group

Item

Patient Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)

CL.2

Code List

Patient Ethnicity

CL Item

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

C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)

CL Item

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

C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BASELINE PHYSICAL EXAM AT TIME OF RANDOMIZATION

Item Group

Physical Exam

PatientPhysicalExaminationDate

Item

Date of Physical Exam (yyyy-mmm-dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

Patient Height

Item

Height (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Body Surface Area

Item

BSA (m^2)

float

C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)

BASELINE HEMATOLOGY AT TIME OF RANDOMIZATION

Item Group

Hematology

SpecimenCollectedDate

Item

Date Specimen collected (for biochemical investigations)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Lab ID

text

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Hemoglobin

Item

Hemoglobin

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Leukocytes (WBC)

Item

WBC

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedurePerformedSpecify

Item

Other

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

BASELINE CA125 AT TIME OF RANDOMIZATION

Item Group

Hematology

SpecimenCollectedDate

Item

Date Specimen collected (for biochemical investigations)

date

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Lab ID

text

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Item

CA125

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

TIMING OF RANDOMIZATION

Item Group

Timing Of Randomization

ADDITIONAL PHYSICAL EXAM

Item Group

Physical Exam

PatientPhysicalExaminationDate

Item

Date of Physical Exam (yyyy-mmm-dd)

date

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Body Surface Area

Item

BSA (m^2)

float

C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)

ECOG Performance Status

Item

ECOG 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.3

Code List

ECOG 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)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

ADDITIONAL BASELINE HEMATOLOGY

Item Group

Hematology

SpecimenCollectedDate

Item

Date Specimen collected (for biochemical investigations)

date

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Lab ID

text

Hemoglobin

Item

Hemoglobin

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Platelets

Item

Peripheral Platelet Count

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Leukocytes (WBC)

Item

WBC

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedurePerformedSpecify

Item

Other

text

ANC

Item

Absolute neutrophil count

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)

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

ADDITIONAL BASELINE BIOCHEMISTRY

Item Group

Biochemistry

SpecimenCollectedDate

Item

Date Specimen collected (for biochemical investigations)

date

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Lab ID

text

Creatinine, Serum

Item

Serum Creatinine

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Bilirubin, Total

Item

Total Bilirubin

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

SGOT (AST)

Item

SGOT (AST)

float

C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedurePerformedSpecify

Item

Other

text

SGPT (ALT)

Item

SGPT (ALT)

float

C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

RADIOLOGY INVESTIGATIONS

Item Group

Radiology Investigations

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

BASELINE ECG

Item Group

Baseline Ecg

DiagnosticElectrocardiogramPerformedDate

Item

Date of EKG

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)

DiagnosticElectrocardiogramPerformedStatus

Item

Result (ECG)

text

C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.4

Code List

Result (ECG)

CL Item

Abnormal - Clinically Significant (Abnormal - Clinically significant)

CL Item

Abnormal - Not Clinically Significant (Abnormal - Not clinically significant)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

TARGET LESIONS

Item Group

Target Lesions

LesionTargetSite

Item

Target Lesion Site (e.g. pelvis)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

TumorLargestDimensionMeasurement

Item

Dimension 1 (End of Reporting Period Measurements)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

TumorSecondDimensionMeasurement

Item

Dimension 2 (End of Reporting Period Measurements)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)

LongestLesionSumDiameterMeasurement

Item

Sum of Longest Diameters of All Target Lesions

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)

NON-TARGET LESIONS

Item Group

Non- Target Lesions During Treatment

LesionNontargetSite

Item

Nontarget Lesion Site (e.g. pelvis)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Assessment Date

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

DISEASE STATUS AT/AFTER DELAYED PRIMARY DEBULKING

Item Group

Disease Status At/after Delayed Primary Debulking

DebulkingPerformedDate

Item

Date of cancer debulking surgery (delayed primary)

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)

LymphNodePathologicInvolvementType

Item

Pathologic Lymph Node Assessment

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)

CL.5

Code List

Pathologic Lymph Node Assessment

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

GynecologicLymphNodeAnatomicSite

Item

Lymph Node Type (If positive)

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.6

Code List

Lymph Node Type (If positive)

CL Item

Para-aortic (para-aortic)

CL Item

Pelvic (pelvic)

C25399 (NCI Thesaurus)
C0030797 (UMLS 2011AA)

CL Item

Other Specify (other)

LymphNodeAnatomicSiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)

CATHETER SELECTION AND PLACEMENT

Item Group

Catheter Selection And Placement

PRIOR NEOADJUVANT SYSTEMIC THERAPY FOR OVARIAN CANCER

Item Group

Prior Neoadjuvant Systemic Therapy For Ovarian Cancer

PriorChemotherapyNeoadjuvantTreatmentRegimenType

Item

Neoadjuvant Chemotherapy

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

Total number of cycles

Item

Total Number of Cycles given

float

C25304 (NCI Thesaurus Property)
C2045831 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property-2)

NeoadjuvantTreatmentAdministeredBeginDate

Item

Start date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

NeoadjuvantTreatmentAdministeredEndDate

Item

End date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

DISEASE HISTORY AT INITIAL DIAGNOSIS

Item Group

Disease History At Initial Diagnosis

PrimaryTumorDiagnosisDate

Item

Date of Definitive Histologic Diagnosis of Primary Tumor (before neoadjuvant chemotherapy)

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)

GynecologicTumorGroupingGynecologicTumorGroupingStage

Item

FIGO staging (at initial Diagnosis by clinical/radiological assessment)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25523 (NCI Thesaurus Property)
C1522242 (UMLS 2011AA Property)

CL.7

Code List

FIGO staging (at initial Diagnosis by clinical/radiological assessment)

CL Item

Stage I Cervical Cancer (I)

C9204 (NCI Thesaurus)
C0278575 (UMLS 2011AA)
C9204 (NCI Thesaurus-3)
C0278575 (UMLS 2011AA-4)

CL Item

Stage Iia Cervical Cancer (IIA)

C6319 (NCI Thesaurus)
C0278588 (UMLS 2011AA)
C6319 (NCI Thesaurus-3)
C0278588 (UMLS 2011AA-4)

CL Item

Stage Iib Cervical Cancer (IIB)

C6320 (NCI Thesaurus)
C0278576 (UMLS 2011AA)
C6320 (NCI Thesaurus-3)
C0278576 (UMLS 2011AA-4)

CL Item

Iic (IIC)

CL Item

Stage Iiia Cervical Cancer (IIIA)

C6322 (NCI Thesaurus)
C1336204 (UMLS 2011AA)
C6322 (NCI Thesaurus-3)
C1336204 (UMLS 2011AA-4)

CL Item

Stage Iiib Cervical Cancer (IIIB)

C6321 (NCI Thesaurus)
C1336219 (UMLS 2011AA)
C6321 (NCI Thesaurus-3)
C1336219 (UMLS 2011AA-4)

CL Item

Iiic (IIIC)

C27982 (NCI Thesaurus)
C0456608 (UMLS 2011AA)

CL Item

Stage Iv Cervical Cancer (IV)

C9206 (NCI Thesaurus)
C0278578 (UMLS 2011AA)
C9206 (NCI Thesaurus-3)
C0278578 (UMLS 2011AA-4)

GynecologicMalignantNeoplasmPrimarySite

Item

Primary Site

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.8

Code List

Primary Site

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Fallopian Tube (Fallopian tube)

C12403 (NCI Thesaurus)
C0015560 (UMLS 2011AA)

CL Item

Other Specify (Other)

MalignantNeoplasmPrimarySiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)

GynecologicTumorHistologicGrade

Item

Histologic Grade

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.9

Code List

Histologic Grade

CL Item

Grade 1-well Differentiated (1)

CL Item

Grade 2-moderately Differentiated (2)

CL Item

Grade 3-poorly Differentiated (3)

CL Item

Grade Unknown (Unknown)

GynecologicTumorHistologicCategory

Item

Histologic 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.10

Code List

Histologic Type

CL Item

Adenocarcinoma, Unspecified (Adenocarcinoma, unspecified)

CL Item

Clear Cell Carcinoma (Clear cell carcinoma)

CL Item

Endometrioid Adenocarcinoma (Endometrioid adenocarcinoma)

C3769 (NCI Thesaurus)
C0206687 (UMLS 2011AA)

CL Item

Mucinous Adenocarcinoma (Mucinous adenocarcinoma)

C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)

CL Item

Mixed Epithelial Carcinoma, Specify Components (Mixed epithelial carcinoma)

CL Item

Serous Adenocarcinoma (Serous adenocarcinoma)

C40101 (NCI Thesaurus)
C0206701 (UMLS 2011AA)

CL Item

Other, Specify (Other specify)

Histologic Type, other

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)

INITIAL DIAGNOSTIC SURGICAL PROCEDURE(S)

Item Group

Initial Diagnostic Surgical Procedure(s)

Surgery Date

Item

Surgery Date

date

C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

AssessmentDiagnosticMethodType

Item

Procedure

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)
C25482 (NCI Thesaurus Property-2)
C0348026 (UMLS 2011AA Property-2)

CL.11

Code List

Procedure

CL Item

Cytology (Cytology)

C16491 (NCI Thesaurus)
C0010819 (UMLS 2011AA)

CL Item

Biopsy (Biopsy)

C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)

CL Item

Primary Debulking (Debulking)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

GynecologicSurgicalProcedurePerformedSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)

OtherPatientAssessmentSpecify

Item

Findings

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus ObjectClass-2)
C0030705 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25406 (NCI Thesaurus ValueDomain-2)
C1524062 (UMLS 2011AA ValueDomain-2)

PRIOR GYNAECOLOGICAL SURGERIES / DIAGNOSTIC PROCEDURES FOR NON-OVARIAN CANCER - QUESTION/TABLE

Item Group

Prior Gynaecological Surgeries / Diagnostic Procedures For Non-ovarian Cancer - Question/table

BASELINE SYMPTOMS/ADVERSE EVENTS

Item Group

Adverse Events / Intercurrent Illness

CommonToxicityCriteriaAdverseEventShortNameType

Item

CTC Adverse Event Short Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)

CTC Adverse Event Term

Item

CTC Select AE

text

C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)

CTC Adverse Event Grade

Item

CTC AE Grade

float

C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)

CONCOMITANT MEASURES/MEDICATIONS (BASELINE)

Item Group

Concomitant Measures/medications

ConcomitantTherapeuticProcedurePerformedText

Item

Name of treatment

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)

Concomitant Medication Use Indication

Item

Reason for Administration

text

C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)

ConcomitantMedicationAdministrationCurrentInd-3

Item

Ongoing? (from previous)

boolean

C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus ValueDomain-2)
C0521116 (UMLS 2011AA ValueDomain-2)

Agent Start Date

Item

Start date

date

C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

Agent End Date

Item

Stop date

date

C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

MAJOR MEDICAL PROBLEMS

Item Group

Major Medical Problems

PatientMedicalHistoryBaselineProblemInd-2

Item

Have there been any major ongoing medical problems? (at baseline)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientMedicalConditionDate

Item

Date Documented (first)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)

PatientMedicalConditionText

Item

Medical condition

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)

PatientHistoryText

Item

Other Relevant Details

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

QUALITY OF LIFE QUESTIONNAIRE

Item Group

Quality Of Life Questionnaire

QualityofLifeCompleteAssessmentInd-2

Item

Was QoL Questionnaire completed?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)

QualityofLifeCompleteAssessmentDate

Item

Date Questionnaire Completed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)

QOLNotAdministeredReason

Item

Specify the reason the questionnaire was not completed

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

CL.16

Code List

Specify the reason the questionnaire was not completed

CL Item

Patient Kept Appointment For Examination, But Could Not Complete Questionnaire Due To Illness (Patient kept appointment for examination, but could not complete questionnaire due to illness)

CL Item

Patient Kept Appointment For Examination, But Refused To Complete Questionnaire For Reasons Other Than Illness (Patient kept appointment for examination, but refused to complete questionnaire for reasons other)

CL Item

Patient Did Not Keep Appointment (Patient did not keep appointment)

CL Item

Patient Could Not Be Contacted (Patient could not be contacted)

CL Item

Test Omitted Due To Institution/investigator Error (Questionnaire not administered due to institutional error)

CL Item

Other Reason (Other reason)

Quality-of-LifeAssessmentOtherIncompleteSpecify

Item

Specify other reason

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Contact Information

Item Group

Contact Information

CRAName

Item

CRA Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)

ClinicalResearchAssociatePersonTelephoneNumber

Item

Phone number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)

ClinicalResearchAssociatePersonFaxNumber

Item

Fax Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)

Institution Name

Item

Institution Name

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

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The aim of the "Initial Evaluation (Form 1)" Folder is to collect information at the time of randomization and prior to start of protocol therapy. The "Initial Evaluation (Form 1)" Folder should be completed by 2 weeks after start of protocol therapy and submitted electronically.

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Unidades de medida

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Unidades de medida

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