ID

7392

Descripción

SOUTHWEST ONCOLOGY GROUP S0226 Advanced Breast Cancer Prestudy S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3227C96-0C14-2773-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3227C96-0C14-2773-E034-0003BA12F5E7

Palabras clave

Versiones (2)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
Subido en

9 de enero de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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NCT00075764 Pre-Study - SOUTHWEST ONCOLOGY GROUP S0226 Advanced Breast Cancer Prestudy - 2174197v3.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0226 Advanced Breast Cancer Prestudy
    1. No Instruction available.
Header
Descripción

Header

SWOG Patient ID
Descripción

Trial subject ID SWOG

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Descripción

Protocol ID SWOG

Tipo de datos

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
Descripción

Registration Number

Tipo de datos

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)
Descripción

Patient Initials

Tipo de datos

text

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

Institution Name

Tipo de datos

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 (Groups Other than SWOG)
Descripción

Investigator Name

Tipo de datos

text

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

Participating Group

Tipo de datos

text

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

Study Number Participating Group

Tipo de datos

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
Pt. ID (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section at the end of the form. Place an X in appropriate boxes. Circle AMENDED items in red.)
Descripción

Trial subject ID Participating Group

Tipo de datos

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
Disease Description At Diagnosis
Descripción

Disease Description At Diagnosis

Date of initial diagnosis of primary tumor
Descripción

FirstPositiveBiopsyDate

Tipo de datos

date

Date progressive, recurrent or metastatic disease first diagnosed
Descripción

RecurrenceDate

Tipo de datos

date

Site(s) of Disease
Descripción

DiseaseSite

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
Other, specify
Descripción

DiseaseSite,Other

Tipo de datos

text

ER Status
Descripción

ERLevelTumorStatus

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
PgR Status
Descripción

PgRStatusType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
Was Her-2/neu status determined?
Descripción

HER2/neuEvaluationIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C17756
UMLS 2011AA ObjectClass
C0242957
HER2/neu Final Diagnosis
Descripción

DiseaseFinalDiagnosisHER2/neuType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C25508
UMLS 2011AA Property-2
C0205088
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C17756
UMLS 2011AA ValueDomain-2
C0242957
Prior Hormonal Therapy
Descripción

PriorHormonalTherapyAdministeredInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prior Systemic Chemotherapy
Descripción

PriorChemotherapyAdministeredInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
High Dose Chemotherapy with marrow or stem cell support
Descripción

PriorAdjuvantHDC/ASCTInd

Tipo de datos

text

Prior Immunotherapy
Descripción

PriorImmunotherapyAdministeredInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Any Other Prior Therapy?
Descripción

PriorTherapyOtherAdministeredInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Name of other prior therapies
Descripción

PriorTherapyOtherName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25364
UMLS 2011AA Property-2
C0600091
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Comments
Descripción

Research Comments

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Ccrr Module For Southwest Oncology Group S0226 Advanced Breast Cancer Prestudy
Descripción

Ccrr Module For Southwest Oncology Group S0226 Advanced Breast Cancer Prestudy

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0226 Advanced Breast Cancer Prestudy
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-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)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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 (Groups Other than SWOG)
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
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
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
Pt. ID (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section at the end of the form. Place an X in appropriate boxes. Circle AMENDED items in red.)
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)
Item Group
Disease Description At Diagnosis
FirstPositiveBiopsyDate
Item
Date of initial diagnosis of primary tumor
date
RecurrenceDate
Item
Date progressive, recurrent or metastatic disease first diagnosed
date
Item
Site(s) of Disease
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Site(s) of Disease
CL Item
local-regional (local-regional)
CL Item
ipsilateral supraclavicular nodes (ipsilateral supraclavicular nodes)
CL Item
opposite breast (opposite breast)
CL Item
distant nodes (distant nodes)
CL Item
distant skin/subcutaneous tissue (distant skin/subcutaneous tissue)
CL Item
bone (bone)
CL Item
bone marrow (bone marrow)
CL Item
lung (lung)
CL Item
pleura (pleura)
CL Item
liver (liver)
CL Item
brain (brain)
CL Item
other CNS (other CNS)
CL Item
Other sites (Other sites)
DiseaseSite,Other
Item
Other, specify
text
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.2
Code List
ER Status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
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.3
Code List
PgR Status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
HER2/neuEvaluationIndicator
Item
Was Her-2/neu status determined?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
Item
HER2/neu Final Diagnosis
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25508 (NCI Thesaurus Property-2)
C0205088 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)
CL.5
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)
Item
Prior Hormonal Therapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.6
Code List
Prior Hormonal Therapy
CL Item
neoadjuvant (neoadjuvant)
CL Item
adjuvant (adjuvant)
Item
Prior Systemic Chemotherapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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)
CL.7
Code List
Prior Systemic Chemotherapy
CL Item
neoadjuvant (neoadjuvant)
CL Item
adjuvant (adjuvant)
Item
High Dose Chemotherapy with marrow or stem cell support
text
CL.8
Code List
High Dose Chemotherapy with marrow or stem cell support
CL Item
neoadjuvant (neoadjuvant)
CL Item
adjuvant (adjuvant)
Item
Prior Immunotherapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.9
Code List
Prior Immunotherapy
CL Item
neoadjuvant (neoadjuvant)
CL Item
adjuvant (adjuvant)
Item
Any Other Prior Therapy?
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.10
Code List
Any Other Prior Therapy?
CL Item
neoadjuvant (neoadjuvant)
CL Item
adjuvant (adjuvant)
PriorTherapyOtherName
Item
Name of other prior therapies
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property-2)
C0600091 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Ccrr Module For Southwest Oncology Group S0226 Advanced Breast Cancer Prestudy
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