ID

43223

Beskrivning

E2108 Step 1 On-Study Form - ARM S Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2ED499-121B-8389-E040-BB89AD4330F7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2ED499-121B-8389-E040-BB89AD4330F7

Nyckelord

D016430

On-Study Form

D001943

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01242800 On-Study - E2108 Step 1 On-Study Form - ARM S - 3130381v1.0

model
Detaljer

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulär

StudyEvent: E2108 Step 1 On-Study Form - ARM S
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header Module

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Clinical Trial Period

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Reporting Period

CL Item

Baseline Step 1 (Baseline step 1)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Header

Item Group

Unnamed2

Patient Initials

Item

Patient Initials (Last, First)

text

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

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

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)

Amended Data

Item Group

Unnamed4

Data amended

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (s M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Pre-Registration Evaluation

Item Group

Unnamed3

ECOG Performance Status

Item

ECOG Performance Status (Day 1 of this cycle)

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

ECOG Performance Status (Day 1 of this cycle)

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)

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)

PatientMenopauseStatus

Item

Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months, or 2 age </= 55 years with no spontaneous menses within the past 12 months e.g. spontaneous or secondary to hysterectomy AND with an FSH level in the postmenopausal range according to local institutional/laboratory standards or > 34.4 IU/L if the institutional range is not available, or 3 history of bilateral oophorectomy, or 4 receiving gonadotropin releasing hormone to suppress ovarian function during the entire period of planned hormonal therapy. Premenopausal: Defined as spontaneous menses occurring within 3 months prior to pre-randomization, and no prior history of bilateral oophorectomy. Perimenopausal: Not meeting criteria for premenopausal or postmenopausal)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.3

Code List

CL Item

Postmenopausal (Postmenopausal)

C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus-3)
C0232970 (UMLS 2011AA-4)
C15421 (NCI Thesaurus-5)
C0232970 (UMLS 2011AA-6)

CL Item

Premenopausal (Premenopausal)

C15491 (NCI Thesaurus)
C0279752 (UMLS 2011AA)

CL Item

Perimenopausal (Perimenopausal)

C15692 (NCI Thesaurus)
C3839366 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Disease Description

Item Group

Disease Description

Palpable Tumor

Item

Is primary tumor palpable?

boolean

C25180 (NCI Thesaurus ValueDomain)
C0746412 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C25606 (NCI Thesaurus ObjectClass-2)

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Item

Her2/neu expression status by immunohistochemistry

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass-2)
C0010802 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C61381 (NCI Thesaurus Property-3)
C0312586 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.5

Code List

Her2/neu expression status by immunohistochemistry

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

CL Item

Not Done: C49484 (not done)

C49484 (NCI Thesaurus)
C1272696 (UMLS 2011AA)

FISHAssessmentChromosome17ResultHER2NeuNumber

Item

FISH HER2/neu chromosome 17 Ratio

float

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property-2)
C0008659 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)

DataUnknownText

Item

Mark an 'X' if unknown

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

ERLevelTumorStatus

Item

ER Status

text

C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.6

Code List

ER Status

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (NOT DONE)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PgRStatusType

Item

PgR Status

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.7

Code List

PgR Status

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (NOT DONE)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

FirstBiopsyPositiveDate

Item

Date of biopsy confirming diagnosis of primary tumor

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

BiopsyProcedure

Item

Biopsy type

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)

CL.20

Code List

Biopsy type

CL Item

Incisional (Incisional)

CL Item

Needle Biopsy (Needle biopsy)

C15190 (NCI Thesaurus)
C0936232 (UMLS 2011AA)

Metastatic Site(s) of Involvement (At Study Entry)

Item Group

Disease Description

MetastaticDiseaseInitialDiagnosisDate

Item

Date of Initial Diagnosis of Metastatic Disease (M D Y)

date

C14174 (NCI Thesaurus ObjectClass)
C0036525 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

OppositeBreastInvolvedInd-3

Item

Opposite Breast

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25602 (NCI Thesaurus ObjectClass-2)
C1521805 (UMLS 2011AA ObjectClass-2)

CL.9

Code List

Opposite Breast

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DataUnknownText

Item

Mark an 'X' if unknown

text

DistantLymphNodeInvolvedInd-3

Item

Distant Lymph Nodes

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus ObjectClass-2)
C0443203 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)

CL.10

Code List

Distant Lymph Nodes

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DistantTissueSubcutaneousInvolvedSkinInd-3

Item

Distant Skin/subcutaneous Tissue

text

C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus ObjectClass-2)
C0040300 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
C13353 (NCI Thesaurus Property-2)
C0443315 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12470 (NCI Thesaurus ValueDomain-2)
C1123023 (UMLS 2011AA ValueDomain-2)

CL.11

Code List

Distant Skin/subcutaneous Tissue

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BoneInvolvedInd-3

Item

Bone

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.12

Code List

Bone

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BoneMarrowInvolvementInd-3

Item

Bone Marrow

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.13

Code List

Bone Marrow

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LungInvolvedInd-3

Item

Lung

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.14

Code List

Lung

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BiopsyProcedure

Item

Biopsy type

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)

CL.20

Code List

Biopsy type

CL Item

Incisional (Incisional)

CL Item

Needle Biopsy (Needle biopsy)

C15190 (NCI Thesaurus)
C0936232 (UMLS 2011AA)

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Item

Liver

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.15

Code List

Liver

CL Item

No (NO)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (YES)

PleuraInvolvedInd-3

Item

Pleura

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12469 (NCI Thesaurus ObjectClass)
C0032225 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.16

Code List

Pleura

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BrainInvolvedInd-3

Item

Brain

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.17

Code List

Brain

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

OtherCNSInvolvedSiteInd-3

Item

Other CNS

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus ObjectClass-2)
C3714787 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.18

Code List

Other CNS

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmMetastaticInvolvementInd-3

Item

Other

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)

CL.19

Code List

Other

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorExtensionSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)

BiopsyMetastasisConfirmedPerformedDate

Item

Date of biopsy confirming diagnosis of metastatic disease (If only one site of metastatic disease coded above:)

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

STATUS OF LOCAL-REGIONAL DISEASE - Prior to initiation of Optimal Systemic Therapy

Item Group

Iib - Local-regional Recurrence

Local-RegionalBreastAxillaryLymphNodeProgressionInd-3

Item

Axillary Node(s) and/or Soft Tissue

boolean

Local-RegionalBreastInfraclavicularLymphNodeProgressionInd-3

Item

Infraclavicular Node(s)

boolean

Local-RegionalBreastIpsilateralSkinProgressionInd-3

Item

Skin of breast

boolean

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property)
C25308 (NCI Thesaurus Property-3)
C0441989 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)

Local-RegionalBreastInternalMammaryLymphNodeProgressionInd-3

Item

Internal mammary node

boolean

Local-RegionalBreastIpsilateralProgressionInd-3

Item

Breast

boolean

Local-RegionalBreastSupraclavicularLymphNodeProgressionInd-3

Item

Supraclavicular Node(s)

boolean

Local-RegionalBreastSkinChestWallProgressionInd-3

Item

Skin of the chest wall

boolean

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25331 (NCI Thesaurus Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property)
C62484 (NCI Thesaurus Property-3)
C0205076 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)

Breast Involvement

Item Group

Status Of Local-regional Disease

BreastSkinNodulePresentInd-2

Item

Skin nodules present?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C3373 (NCI Thesaurus Property-2)
C0037287 (UMLS 2011AA Property-2)

BreastSkinNodulePresentSumLongestDiameterValue

Item

Sum of longest diameter of largest five nodules (If yes,)

float

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3373 (NCI Thesaurus Property-2)
C0037287 (UMLS 2011AA Property-2)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25483 (NCI Thesaurus ValueDomain-3)
C0439534 (UMLS 2011AA ValueDomain-3)

BreastUlcerationPresentInd-2

Item

Ulceration present?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25757 (NCI Thesaurus Property-2)
C0041582 (UMLS 2011AA Property-2)

BreastUlcerationPresentLongestDimensionValue

Item

Area of Ulceration (If yes,)

float

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25757 (NCI Thesaurus Property-2)
C0041582 (UMLS 2011AA Property-2)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25483 (NCI Thesaurus ValueDomain-3)
C0439534 (UMLS 2011AA ValueDomain-3)

BreastUlcerationPresentLongestPerpendicularAxisValue

Item

Area of Ulceration

float

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25757 (NCI Thesaurus Property-2)
C0041582 (UMLS 2011AA Property-2)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C54649 (NCI Thesaurus ValueDomain-3)
C1295725 (UMLS 2011AA ValueDomain-3)

BreastNeoplasmMobilityPresentType

Item

Tumor Mobility

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25626 (NCI Thesaurus Property-2)
C0150312 (UMLS 2011AA Property-2)
C77919 (NCI Thesaurus Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.30

Code List

Tumor Mobility

CL Item

Attached To Fascia (Attached to fascia)

CL Item

Chest Wall Fixation (Chest wall fixation)

CL Item

Free (Free)

BreastMalignantNeoplasmInvasionSkinPresentInd-2

Item

Is direct invasion of tumor into skin present?

boolean

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C75004 (NCI Thesaurus Property-4)
C2699153 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

BreastMalignantNeoplasmInvasionSkinPresentLongestDimensionValue

Item

Longest dimension of skin invasion (If yes,)

float

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C75004 (NCI Thesaurus Property-4)
C2699153 (UMLS 2011AA Property-4)
C25558 (NCI Thesaurus ValueDomain)
C1522425 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25483 (NCI Thesaurus ValueDomain-3)
C0439534 (UMLS 2011AA ValueDomain-3)

BreastAsymptomaticMalignantNeoplasmPresentInd-2

Item

Asymptomatic tumor in the intact breast present?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C3833 (NCI Thesaurus Property-3)
C0231221 (UMLS 2011AA Property-3)

Comments

Item Group

Comments

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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Breast Cancer NCT01242800 On-Study - E2108 Step 1 On-Study Form - ARM S - 3130381v1.0

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

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