ID

10983

Beschreibung

NSABP PROTOCOL B-36: ON-STUDY FORM NCT00087178 Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C8932DDB-5B56-0031-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C8932DDB-5B56-0031-E034-0003BA12F5E7

Stichworte

  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 16.06.15 16.06.15 -
Hochgeladen am

16. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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NSABP PROTOCOL B-36: ON-STUDY FORM NCT00087178

No Instruction available.

  1. StudyEvent: NSABP PROTOCOL B-36: ON-STUDY FORM
    1. No Instruction available.
Header
Beschreibung

Header

Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Beschreibung

Patient ID NSABP

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Institution Name
Beschreibung

Institution Name

Datentyp

text

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

Affiliate Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Person Completing Form (Phone)
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Are data amended?
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Surgery
Beschreibung

Surgery

Most Extensive Primary Surgery
Beschreibung

PrimarySurgeryType

Datentyp

text

Were margins histologically free of invasive tumor and DCIS? (If partial mastectomy/lumpectomy/excisional biopsy:)
Beschreibung

ArethefinalmarginsoftheresectedspecimenhistologicallyfreeofDCIS?

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25508
UMLS 2011AA ObjectClass
C0205088
NCI Thesaurus ObjectClass-2
C25563
UMLS 2011AA ObjectClass-2
C0205284
NCI Thesaurus Property
C25547
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property
C0205462
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Surgical Procedures
Beschreibung

Surgical Procedures

Core Needle Biopsy (1.)
Beschreibung

SurgicalProcedureCoreBiopsyPerformedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15680
UMLS 2011AA Property
C1318309
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
Excisional Biopsy or Lumpectomy (2.)
Beschreibung

SurgicalProcedureLumpectomyExcisionalBiopsyPerformed

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15755
UMLS 2011AA Property
C0024885
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C15385
UMLS 2011AA Property-3
C0184921
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Resection of Lumpectomy Margins (3.)
Beschreibung

SurgicalProcedureLumpectomySurgicalMarginExcisionPerformedInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15755
UMLS 2011AA Property
C0024885
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C15232
UMLS 2011AA Property-3
C0728940
NCI Thesaurus Property-4
C41227
UMLS 2011AA Property-4
C0229985
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total Mastectomy (4.)
Beschreibung

TotalMastectomy

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
Sentinel Node Biopsy (5.)
Beschreibung

SentinelNodeBiopsyInd-3

Datentyp

text

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
Axillary Dissection or Axillary Sampling (6.)
Beschreibung

AxillaSamplingInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12674
UMLS 2011AA ObjectClass
C0004454
NCI Thesaurus Property
C25662
UMLS 2011AA Property
C0441621
DATE OF PROCEDURE (Month, Day, Year)
Beschreibung

SurgicalProcedurePerformedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
ACCESSION NUMBER (Pathology Specimen Number)
Beschreibung

SpecimenAccessionNumber

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25402
UMLS 2011AA Property
C1510755
Patient status
Beschreibung

Patient status

Menopausal Status (per protocol criteria)
Beschreibung

MenopausalStatus

Datentyp

text

Date Baseline QOL Completed by Patient (0=not applicable)
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Date Celecoxib/Placebo Began (0=not begun)
Beschreibung

Medication Start Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent
Beschreibung

Agent

Datentyp

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
UMLS CUI-1
C1521826
Disease Description
Beschreibung

Disease Description

Tumor Laterality
Beschreibung

PrimaryTumorLateralityType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
ER (Receptor Status)
Beschreibung

ERLevelTumorStatus

Datentyp

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 (Receptor Status)
Beschreibung

PgRStatus

Datentyp

text

Pathologic Primary Tumor Size (cm)
Beschreibung

PathologicTumorPrimarySizeMeasurement

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25610
UMLS 2011AA ObjectClass-2
C1521733
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus Property-2
C25681
UMLS 2011AA Property-2
C0456389
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Histologic Grade (Use combined histologic grade SBR/Elston classification)
Beschreibung

HistologicGrade

Datentyp

text

Ccrr Module For Nsabp Protocol B-36: On-study Form
Beschreibung

Ccrr Module For Nsabp Protocol B-36: On-study Form

Ähnliche Modelle

No Instruction available.

  1. StudyEvent: NSABP PROTOCOL B-36: ON-STUDY FORM
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
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)
Affiliate Name
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Surgery
Item
Most Extensive Primary Surgery
text
Code List
Most Extensive Primary Surgery
CL Item
Partial Mastectomy/lumpectomy/excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Total Mastectomy (Total Mastectomy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
Item
Were margins histologically free of invasive tumor and DCIS? (If partial mastectomy/lumpectomy/excisional biopsy:)
text
C25508 (NCI Thesaurus ObjectClass)
C0205088 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus ObjectClass-2)
C0205284 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Were margins histologically free of invasive tumor and DCIS? (If partial mastectomy/lumpectomy/excisional biopsy:)
CL Item
Free (Free)
CL Item
Not free (Not free)
Item Group
Surgical Procedures
Item
Core Needle Biopsy (1.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
Code List
Core Needle Biopsy (1.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Excisional Biopsy or Lumpectomy (2.)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15385 (NCI Thesaurus Property-3)
C0184921 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Excisional Biopsy or Lumpectomy (2.)
CL Item
Y (Y)
CL Item
N (N)
Item
Resection of Lumpectomy Margins (3.)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15232 (NCI Thesaurus Property-3)
C0728940 (UMLS 2011AA Property-3)
C41227 (NCI Thesaurus Property-4)
C0229985 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Resection of Lumpectomy Margins (3.)
CL Item
Y (Y)
CL Item
N (N)
Item
Total Mastectomy (4.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
Code List
Total Mastectomy (4.)
CL Item
Y (Y)
CL Item
N (N)
Item
Sentinel Node Biopsy (5.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Code List
Sentinel Node Biopsy (5.)
CL Item
Y (Y)
CL Item
N (N)
Item
Axillary Dissection or Axillary Sampling (6.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12674 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C25662 (NCI Thesaurus Property)
C0441621 (UMLS 2011AA Property)
Code List
Axillary Dissection or Axillary Sampling (6.)
CL Item
Y (Y)
CL Item
N (N)
SurgicalProcedurePerformedDate
Item
DATE OF PROCEDURE (Month, Day, Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
SpecimenAccessionNumber
Item
ACCESSION NUMBER (Pathology Specimen Number)
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25402 (NCI Thesaurus Property)
C1510755 (UMLS 2011AA Property)
Item Group
Patient status
Item
Menopausal Status (per protocol criteria)
text
Code List
Menopausal Status (per protocol criteria)
CL Item
Premenopausal (Premenopausal)
CL Item
Postmenopausal (Postmenopausal)
Date Form Completed
Item
Date Baseline QOL Completed by Patient (0=not applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Medication Start Date
Item
Date Celecoxib/Placebo Began (0=not begun)
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
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
Item Group
Disease Description
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
Code List
Tumor Laterality
CL Item
Left (Left breast)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right breast)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
Item
ER (Receptor 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)
Code List
ER (Receptor Status)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
PgR (Receptor Status)
text
Code List
PgR (Receptor Status)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PathologicTumorPrimarySizeMeasurement
Item
Pathologic Primary Tumor Size (cm)
float
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS 2011AA ObjectClass-2)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property-2)
C0456389 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item
Histologic Grade (Use combined histologic grade SBR/Elston classification)
text
Code List
Histologic Grade (Use combined histologic grade SBR/Elston classification)
CL Item
Low Grade (Low)
C14161 (NCI Thesaurus)
C1282907 (UMLS 2011AA)
CL Item
Intermediate (Intermediate)
CL Item
High Grade (High)
C14158 (NCI Thesaurus)
C0205082 (UMLS 2011AA)
Item Group
Ccrr Module For Nsabp Protocol B-36: On-study Form

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