ID

9376

Beschrijving

SOUTHWEST ONCOLOGY GROUP S0221 BREAST CANCER PRESTUDY FORM Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6788C86-182E-5088-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6788C86-182E-5088-E034-0003BA0B1A09

Trefwoorden

D016430

C50-C50.9

Pre-Study Form

18-12-14 18-12-14 - Martin Dugas
09-01-15 09-01-15 - Martin Dugas

Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00070564 Pre-Study - SOUTHWEST ONCOLOGY GROUP S0221 BREAST CANCER PRESTUDY FORM - 2046547v3.0

model
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No Instruction available.

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StudyEvent: SOUTHWEST ONCOLOGY GROUP S0221 BREAST CANCER PRESTUDY FORM
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header

Item Group

Header

SWOGPatientID

Item

SWOG Patient ID

text

SWOGStudyNo.

Item

SWOG Study No.

text

RegistrationStep

Item

Registration Step

text

Patient Initials

Item

Patient Initials (L, F M)

text

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

MainMemberInstitution/Affiliate

Item

Institution / Affiliate

text

RegisteredInvestigator

Item

Physician

text

Participating Group

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

StudyNo.

Item

Participating Group Study No.

text

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

PATIENT CHARACTERISTICS

Item Group

Patient Characteristics

MenopausalStatus

Item

Menopausal status (select one)

text

CL.1

Code List

Menopausal status (select one)

CL Item

Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre)

CL Item

Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post)

CL Item

Above Categories Not Applicable And Age < 50 (Above not applicable AND age < 50)

CL Item

Above Categories Not Applicable And Age => 50 (Above not applicable AND age >= 50)

CL Item

NA-male (NA-male)

PatientNegativePregnancyTestDate

Item

Negative urine or serum pregnancy test date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)

PatientHeight

Item

Height (cm)

float

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeight

Item

Weight (kg)

float

BodySurfaceArea

Item

BSA (m2)

float

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

ECOG Performance Status

Item

Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

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)

DISEASE DESCRIPTION

Item Group

Disease Description

FirstPositiveBiopsyDate

Item

Date of Initial Diagnosis of Primary Tumor

date

BreastTumorStageGroupingStage

Item

Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C38027 (NCI Thesaurus Property)
C1519504 (UMLS 2011AA Property)

CL.3

Code List

Stage

CL Item

T1*, N0, M0 (I)

CL Item

T0, N1, M0 Or T1*, N1, M0 Or T2, N0, M0 Or T2, N1, M0 Or T3, N0, M0 (II)

CL Item

T0, N2, M0 Or T1*, N2, M0 Or T2, N2, M0 Or T3, N1, M0 Or T3, N2, M0 Or T4, N0, M0 Or T4, N1, M0 Or T4, N2, M0 Or Any T, N3, M0 (III)

PrimaryTumorLaterality

Item

Tumor Laterality (select one)

text

CL.4

Code List

Tumor Laterality (select one)

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

CL Item

Bilateral (Bilateral)

PathologicPrimaryTumorSize

Item

Pathologic Primary Tumor Size (Maximum diameter of the invasive component; if multiple lesions, use longest lesion)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

LymphNode(s)PositiveNumber

Item

Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)

float

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

ERStatus

Item

ER Status

text

CL.5

Code List

ER Status

CL Item

Negative (ER-)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (ER+)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

PgRStatus

Item

PgR Status

text

CL.6

Code List

PgR Status

CL Item

Negative (PgR-)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (PgR+)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

WasHER-2/neustatusdetermined?

Item

Was HER-2/neu status determined?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

HER2/neuFinalDiagnosis

Item

HER2/neu final diagnosis

text

CL.8

Code List

HER2/neu final diagnosis

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2

Item

Was an Oncotype DX assay performed

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)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)

LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

Item

Oncotype DX Recurrence Score (If yes)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

LABORATORY VALUES

Item Group

Laboratory Values

ANC

Item

ANC (mcl)

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

Peripheral Platelet Count (mcl)

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)

Bilirubin, Total

Item

Total Bilirubin (mg/dL)

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)

Bilirubin, Total ULN

Item

Total Bilirubin ULN (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

SGOT (AST)

Item

SGOT (AST) (U/L)

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)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN (U/L)

float

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)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

SGPT (ALT)

Item

SGPT (ALT) (U/L)

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)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

SGPT (ALT) ULN (U/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Alkaline Phosphatase

Item

Alkaline Phosphatase (U/L)

float

C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)

Creatinine, Serum

Item

Serum creatinine (mg/dL)

float

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

Creatinine, serum ULN

Item

Creatinine ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

LeftVentricularEjectionFractionAssessmentType

Item

Ejection fraction

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)

CL.10

Code List

Ejection fraction

CL Item

Radionuclide Ventriculogram Scan (Multiple Gated Acquisition (MUGA))

C38073 (NCI Thesaurus)
C0521317 (UMLS 2011AA)

CL Item

Echocardiogram (Echocardiogram)

C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)

HeartLVEFTestPercentageValue

Item

LVEF (%)

float

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

HeartEjectionFractionLowerLimitofNormalLaboratoryProcedureLabPercentageValue

Item

LLN

float

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus Property-3)
C1518030 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

SpecimenCollectedDate

Item

Collection Date

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)

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

PRIOR TREATMENT RELATED TO THIS CANCER

Item Group

Prior Treatment Related To This Cancer

PrimarySurgeryType

Item

Most Extensive Primary Surgery (select one)

text

CL.11

Code List

Most Extensive Primary Surgery (select one)

CL Item

Partial Mastectomy/lumpectomy/excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)

CL Item

Mastectomy, Nos (Mastectomy, NOS)

PrimarySurgeryDate

Item

Date of Most Extensive Primary Surgery (If required, use last re-excision date)

date

SentinelNodeBiopsyInd

Item

Was sentinel node sampling performed?

boolean

SentinelNodeBiopsyDate

Item

Sentinal Node Biopsy Date

date

SentinelNodeBiopsyResults

Item

Sentinel Node Biopsy Results

text

CL.13

Code List

Sentinel Node Biopsy Results

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

AxillaryDissectionInd

Item

Was axillary dissection performed?

boolean

AxillaryDissectionDate

Item

Date of Axillary Dissection

date

LymphNode(s)ExaminedNumber

Item

Number of Lymph Nodes Examined (If sentinal node biopsy and axillary node dissection were performed, enter the sum of positive nodes examined.)

float

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

PriorCytotoxicChemotherapyBreastCarcinomaAdministeredInd-2

Item

Prior cytotoxic chemotherapy for this breast cancer?

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15681 (NCI Thesaurus ObjectClass-2)
C0677881 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus Property)
C0678222 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorAnthracyclineTherapyRegimenInd-2

Item

Prior anthracycline chemotherapy

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C1594 (NCI Thesaurus ObjectClass-3)
C0003234 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorChemotherapyTaxaneCompoundAdministeredInd-2

Item

Prior taxane chemotherapy?

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1490 (NCI Thesaurus Property-2)
C0796419 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Prior Radiation Therapy

Item

Prior Radiation Therapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

PriorTherapyOtherEndDate

Item

Date of completion (If yes,)

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Comments Module

Item Group

Ccrr Module For Southwest Oncology Group S0221 Breast Cancer Prestudy Form

Research Comments

Item

Comments

text

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

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Item Commentaren voor :

Breast Cancer NCT00070564 Pre-Study - SOUTHWEST ONCOLOGY GROUP S0221 BREAST CANCER PRESTUDY FORM - 2046547v3.0

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