ID

11960

Beschreibung

SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

Stichworte

Versionen (3)
  1. 18.12.14 18.12.14 - Martin Dugas
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 26.08.15 26.08.15 - Martin Dugas
Hochgeladen am

26. August 2015

DOI

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Pre-Study Breast Cancer SWOG S0307 NCT00127205

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM
    1. No Instruction available.
Administrative documentation
Beschreibung

Administrative documentation

Alias
UMLS CUI-1
C1320722
SWOG Patient ID
Beschreibung

Patient Southwest Oncology Group Identifier Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
UMLS CUI-1
C1549740
UMLS CUI-2
C1519429
SWOG Study No.
Beschreibung

Protocol ID SWOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Beschreibung

Registration Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
UMLS CUI-1
C2986440
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician
Beschreibung

Investigator Name

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Disease Description
Beschreibung

Disease Description

Performance Status
Beschreibung

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
UMLS CUI-1
C1520224
Histologically confirmed primary invasive adenocarcinoma of the breast
Beschreibung

BreastPrimaryInvasiveAdenocarcinomaHistologicallyConfirmedStage

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2852
NCI Thesaurus ObjectClass-2
C25251
NCI Thesaurus ObjectClass-3
C12971
NCI Thesaurus ObjectClass-4
C14159
NCI Thesaurus Property
C25458
NCI Thesaurus Property-2
C25527
NCI Thesaurus ValueDomain
C16899
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0205281
UMLS CUI [1,5]
C0750484
Laboratory Values
Beschreibung

Laboratory Values

Serum creatinine
Beschreibung

Creatinine, Serum

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C13325
NCI Thesaurus Property-2
C399
UMLS CUI [1]
C0201976
mg/dL
Creatinine ULN
Beschreibung

Creatinine, Serum ULN

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
mg/dL
Collection Date (mm/dd/yyyy)
Beschreibung

SpecimenCollectedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property
C2745955
Previous bisphosphonate
Beschreibung

PriorBisphosphonateTherapyType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C443
UMLS 2011AA ObjectClass
C0012544
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of dental examination (mm/dd/yyyy)
Beschreibung

DentalExamDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41136
UMLS 2011AA ObjectClass
C0226984
Bone Pain
Beschreibung

Bone Pain

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C3303
NCI Thesaurus ObjectClass
C12366
UMLS CUI-1
C0151825
Bone Metastasis
Beschreibung

MalignantNeoplasmBoneMetastaticInvolvementInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C12366
NCI Thesaurus Property-3
C25548
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0153690
Consent For Submission And Banking
Beschreibung

Consent For Submission And Banking

Consent for submission and banking
Beschreibung

PatientTissueBankingConsentStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Metathesaurus Property
C0087095
Patient Characteristics
Beschreibung

Patient Characteristics

Menopausal status (select one:)
Beschreibung

PatientMenopauseCategory

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ValueDomain-2
C3231
UMLS 2011AA ValueDomain-2
C0025320
Height
Beschreibung

Height

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI [1]
C0005890
cm
Body weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI [1]
C0005910
kg
Body surface area
Beschreibung

BSA

Datentyp

float

Maßeinheiten
  • m²
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI [1]
C0005902
m²
Disease Description
Beschreibung

Disease Description

Date of Initial Diagnosis of Primary Tumor
Beschreibung

FirstBiopsyPositiveDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Tumor Laterality (select one:)
Beschreibung

PrimaryTumorLateralityType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C25251
NCI Thesaurus Property
C25185
UMLS CUI-1
C0441987
UMLS CUI-2
C0475445
Pathologic Primary Tumor Size (cm.)
Beschreibung

PathologicTumorPrimarySizeMeasurement

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C25610
NCI Thesaurus Property
C25251
NCI Thesaurus Property-2
C25681
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0475440
cm
Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
Beschreibung

LymphNodePositiveCount

Datentyp

integer

Alias
NCI Thesaurus Property
C25246
NCI Thesaurus ObjectClass
C12745
NCI Thesaurus ValueDomain
C25463
UMLS CUI-1
C0237753
UMLS CUI-2
C0746319
ER Status
Beschreibung

ERLevelTumorStatus

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C3262
NCI Thesaurus ObjectClass
C17069
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25554
UMLS CUI-1
C2919271
PgR Status
Beschreibung

PgRStatusType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C17075
NCI Metathesaurus Property
C0678257
UMLS CUI-1
C2919590
Was HER-2/neu status determined?
Beschreibung

WasHER-2/neustatusdetermined?

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1522602
If Yes, HER2/neu final diagnosis
Beschreibung

HER2/neu Final Diagnosis

Datentyp

text

Treatment With Statins
Beschreibung

Treatment With Statins

Is the patient currently taking a statin (atorvastatin Lipitor, pravastatin Pravachol, simvastatin Zocor, lovastatin Mevacor, fluvastatin Lescol, rosuvastatin Crestor?)
Beschreibung

TherapyHMG-CoAReductaseInhibitorAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
NCI Thesaurus Property-2
C1655
UMLS CUI-1
C1512699
UMLS CUI-2
C1521801
UMLS CUI-3
C0360714
Length of time on statin
Beschreibung

TherapyHMG-CoAReductaseInhibitorAdministeredDuration

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
NCI Thesaurus Property-2
C1655
UMLS 2011AA Property-2
C0360714
Patient Preference
Beschreibung

Patient Preference

If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
Beschreibung

BisphosphonateTherapyAdministrationType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Prior Treatment Related To This Cancer
Beschreibung

Prior Treatment Related To This Cancer

Most Extensive Primary Surgery (select one:)
Beschreibung

BreastPrimarySurgicalProcedurePerformedType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C15329
UMLS 2011AA ObjectClass-3
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of surgery
Beschreibung

Primary surgery Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25251
NCI Thesaurus ObjectClass-2
C15329
NCI Thesaurus Property
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI [1]
C1628561
Was sentinel node sampling performed?
Beschreibung

SentinelNodeBiopsyInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Sentinel Node Biopsy Date
Beschreibung

SentinelNodeBiopsyDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Sentinel Node Biopsy Results
Beschreibung

SentinelNodePathologicResultProcedure

Datentyp

text

Alias
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Was axillary dissection performed?
Beschreibung

AxillaryNodeDissectionPerformedInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Date of Axillary Dissection
Beschreibung

AxillarySurgeryDissectionDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C13351
UMLS 2011AA ObjectClass
C0004454
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Systemic Treatment For This Cancer
Beschreibung

Systemic Treatment For This Cancer

Chemotherapy (select one:)
Beschreibung

ChemotherapyAdministrationIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
Date chemotherapy completed (If completed,)
Beschreibung

ChemotherapyAdministeredEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Hormone therapy (select one:)
Beschreibung

HormoneTherapyAdministeredInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
If currently receiving
Beschreibung

HormoneTherapyAdministeredType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
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1 Formulare
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Patient ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1519429 (UMLS CUI-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-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)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
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)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
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)
Study Number Participating Group
Item
Participating Group Study No.
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)
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)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Disease Description
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI-1)
CL.1
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
Histologically confirmed primary invasive adenocarcinoma of the breast
text
C2852 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C12971 (NCI Thesaurus ObjectClass-3)
C14159 (NCI Thesaurus ObjectClass-4)
C25458 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
C0001418 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0205281 (UMLS CUI [1,4])
C0750484 (UMLS CUI [1,5])
CL.2
Code List
Histologically confirmed primary invasive adenocarcinoma of the breast
CL Item
Stage I (Stage I)
C27966 (NCI Thesaurus)
C0441766 (UMLS 2011AA)
CL Item
Stage Ii (Stage II)
C28054 (NCI Thesaurus)
C0441767 (UMLS 2011AA)
CL Item
Stage Iii (Stage III)
C27970 (NCI Thesaurus)
C0441771 (UMLS 2011AA)
Item Group
Laboratory Values
Creatinine, Serum
Item
Serum creatinine
float
C16960 (NCI Thesaurus ObjectClass)
C13325 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0201976 (UMLS CUI [1])
Creatinine, Serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
SpecimenCollectedDate
Item
Collection Date (mm/dd/yyyy)
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)
Item
Previous bisphosphonate
text
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Previous bisphosphonate
CL Item
Intravenous: C13346 (IV)
C13346 (NCI Thesaurus)
C0348016 (UMLS 2011AA)
CL Item
Oral (Oral)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
CL Item
None: C41132 (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
DentalExamDate
Item
Date of dental examination (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41136 (NCI Thesaurus ObjectClass)
C0226984 (UMLS 2011AA ObjectClass)
Bone Pain
Item
Bone Pain
boolean
C38147 (NCI Thesaurus ValueDomain)
C3303 (NCI Thesaurus Property)
C12366 (NCI Thesaurus ObjectClass)
C0151825 (UMLS CUI-1)
Bone Metastasis
Item
Bone Metastasis
boolean
C9305 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus Property)
C12366 (NCI Thesaurus Property-2)
C25548 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0153690 (UMLS CUI-1)
Item Group
Consent For Submission And Banking
Item
Consent for submission and banking
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C0087095 (NCI Metathesaurus Property)
CL.6
Code List
Consent for submission and banking
CL Item
Accepted Tissue Submission (Accepted tissue submission)
CL Item
Declined Tissue Submission (Declined tissue submission)
CL Item
Accepted Serum Submission (Accepted serum submission)
CL Item
Declined Serum Submission (Declined serum submission)
Item Group
Patient Characteristics
Item
Menopausal status (select one:)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain-2)
C0025320 (UMLS 2011AA ValueDomain-2)
CL.7
Code List
Menopausal status (select one:)
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement))
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR > 12 mo since LMP with no prior hysterectomy))
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)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI [1])
Item Group
Disease Description
FirstBiopsyPositiveDate
Item
Date of Initial 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)
Item
Tumor Laterality (select one:)
text
C25284 (NCI Thesaurus ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0441987 (UMLS CUI-1)
C0475445 (UMLS CUI-2)
CL.8
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)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
Tumor size
Item
Pathologic Primary Tumor Size (cm.)
float
C3262 (NCI Thesaurus ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C25251 (NCI Thesaurus Property)
C25681 (NCI Thesaurus Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0475440 (UMLS CUI-1)
Number of positive lymph nodes
Item
Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
integer
C25246 (NCI Thesaurus Property)
C12745 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0237753 (UMLS CUI-1)
C0746319 (UMLS CUI-2)
Item
ER Status
text
C3262 (NCI Thesaurus ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C25554 (NCI Thesaurus Property)
C2919271 (UMLS CUI-1)
CL.9
Code List
ER Status
CL Item
Negative (ER-)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (ER+)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
PgR Status
text
C25284 (NCI Thesaurus ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C2919590 (UMLS CUI-1)
CL.10
Code List
PgR Status
CL Item
Negative (PgR-)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (PgR+)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
HER-2/neu status determined
Item
Was HER-2/neu status determined?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS CUI-1)
Item
If Yes, HER2/neu final diagnosis
text
CL.12
Code List
If Yes, 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)
Item Group
Treatment With Statins
TherapyHMG-CoAReductaseInhibitorAdministeredInd-3
Item
Is the patient currently taking a statin (atorvastatin Lipitor, pravastatin Pravachol, simvastatin Zocor, lovastatin Mevacor, fluvastatin Lescol, rosuvastatin Crestor?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1655 (NCI Thesaurus Property-2)
C1512699 (UMLS CUI-1)
C1521801 (UMLS CUI-2)
C0360714 (UMLS CUI-3)
Item
Length of time on statin
text
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
C1655 (NCI Thesaurus Property-2)
C0360714 (UMLS 2011AA Property-2)
CL.14
Code List
Length of time on statin
CL Item
< 1 Yr (< 1 yr)
CL Item
1-2 Yrs (1-2 yrs)
CL Item
2-3 Yrs (2-3 yrs)
CL Item
3-4 Yrs (3-4 yrs)
CL Item
>4 Yrs (>4 yrs)
Item Group
Patient Preference
Item
If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CL.15
Code List
If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
CL Item
Oral (Oral)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
CL Item
Intravenous (Intravenous)
X-MO-6794 (MGED)
Item Group
Prior Treatment Related To This Cancer
Item
Most Extensive Primary Surgery (select one:)
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.16
Code List
Most Extensive Primary Surgery (select one:)
CL Item
Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
Primary surgery Date
Item
Date of surgery
date
C25251 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1628561 (UMLS CUI [1])
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Item
Sentinel Node Biopsy Results
text
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
CL.18
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)
AxillaryNodeDissectionPerformedInd-3
Item
Was axillary dissection performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
AxillarySurgeryDissectionDate
Item
Date of Axillary Dissection
date
C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Systemic Treatment For This Cancer
Item
Chemotherapy (select one:)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
CL.20
Code List
Chemotherapy (select one:)
CL Item
Currently Receiving (Currently receiving)
CL Item
Planned (Planned)
C25619 (NCI Thesaurus)
C1301732 (UMLS 2011AA)
CL Item
Not Planned (Not planned)
CL Item
Completed (Completed)
ChemotherapyAdministeredEndDate
Item
Date chemotherapy completed (If completed,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Hormone therapy (select one:)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.21
Code List
Hormone therapy (select one:)
CL Item
Currently Receiving (Currently receiving)
CL Item
Planned (Planned)
C25619 (NCI Thesaurus)
C1301732 (UMLS 2011AA)
CL Item
Not Planned (Not planned)
Item
If currently receiving
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.22
Code List
If currently receiving
CL Item
Serm (SERM)
CL Item
Aromatase Inhibitor (Aromatase inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Ovarian Suppression (Ovarian suppression)
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