ID

10478

Beschreibung

NSABP PROTOCOL B-35 ON-STUDY FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A051F12F-A237-0456-E034-080020C9C0E0 NCT00053898

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A051F12F-A237-0456-E034-080020C9C0E0

Stichworte

Versionen (3)
  1. 18.12.14 18.12.14 - Martin Dugas
  2. 02.06.15 02.06.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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NSABP PROTOCOL B-35 ON-STUDY FORM NCT00053898

Englisch

Form ON (04-30-2002) Submit within 30 days of registration. Attach All applicable Operative Reports and Pathology Reports.

1 Formulare  
NSABP administration data
Beschreibung

NSABP administration data

First Three Letters of Patient's Last Name
Beschreibung

FirstThreeLettersofPatient'sLastName

Datentyp

text

Patient Study ID
Beschreibung

PatientStudyID

Datentyp

text

Institution Name
Beschreibung

InstitutionName

Datentyp

text

Affiliate Name
Beschreibung

AffiliateName

Datentyp

text

Person Completing Form Last Name
Beschreibung

PersonCompletingForm,LastName

Datentyp

text

Person Completing Form First Name
Beschreibung

PersonCompletingForm,FirstName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Person Completing Form Phone
Beschreibung

PersonCompletingForm,Phone

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Are data amended? (If Yes, circle the amended items in red.)
Beschreibung

AmendedDataInd

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Biopsy results
Beschreibung

Biopsy results

Fine Needle Aspiration Cytology (Circle Y or N for Yes, No)
Beschreibung

FineNeedleAspirationCytology

Datentyp

text

Core (or Tru Cut) Needle Biopsy (Circle Y or N for Yes, No)
Beschreibung

Core(orTruCut)NeedleBiopsy

Datentyp

text

Incisional Biopsy (Circle Y or N for Yes, No)
Beschreibung

IncisionalBiopsy

Datentyp

text

Excisional Biopsy or Lumpectomy (Circle Y or N for Yes, No)
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 (Circle Y or N for Yes, No)
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
Sentinel Node Biopsy (Circle Y or N for Yes, No)
Beschreibung

SentinelNodeBiopsyInd

Datentyp

text

Axillary Dissection (Circle Y or N for Yes, No)
Beschreibung

AxillaryDissectionInd

Datentyp

text

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

AccessionNumber

Datentyp

float

Disease Description
Beschreibung

Disease Description

Tumor Laterality
Beschreibung

PrimaryTumorLaterality

Datentyp

text

Was the tumor or microcalcification evident on mammogram?
Beschreibung

Wasthetumorormicrocalcificationevidentonmammogram?

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Was the tumor evident by ultrasound?
Beschreibung

Wasthetumorevidentbyultrasound?

Datentyp

text

Was the tumor palpable?
Beschreibung

PalpableTumorPresentIndicator

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass-2
C25606
UMLS 2011AA ObjectClass-2
C0522499
Were there any breast symptoms? (e.g., pain, nipple discharge or retraction, skin dimpling)
Beschreibung

Werethereanybreastsymptoms?

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Receptor Status (by Ihc)
Beschreibung

Receptor Status (by Ihc)

ER Status
Beschreibung

ERStatus

Datentyp

text

PgR
Beschreibung

PgRStatus

Datentyp

text

If unknown, please explain:
Beschreibung

Ifunknown,pleaseexplain:

Datentyp

text

Quality Of Life
Beschreibung

Quality Of Life

Did the patient complete the Quality of Life baseline form?
Beschreibung

DidthepatientcompletetheQualityofLifebaselineform?

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If the baseline QOL form was not completed, indicate the reason below. (Protocol Approved Reasons)
Beschreibung

BaselineQOLIncompleteFormReason

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus ObjectClass-2
C25213
UMLS 2011AA ObjectClass-2
C1442488
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other Reason (if applicable)
Beschreibung

OtherReason(ifapplicable)

Datentyp

text

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Ähnliche Modelle

Form ON (04-30-2002) Submit within 30 days of registration. Attach All applicable Operative Reports and Pathology Reports.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
NSABP administration data
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patient's Last Name
text
PatientStudyID
Item
Patient Study ID
text
InstitutionName
Item
Institution Name
text
AffiliateName
Item
Affiliate Name
text
PersonCompletingForm,LastName
Item
Person Completing Form Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PersonCompletingForm,Phone
Item
Person Completing Form Phone
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
AmendedDataInd
Item
Are data amended? (If Yes, circle the amended items in red.)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Biopsy results
Item
Fine Needle Aspiration Cytology (Circle Y or N for Yes, No)
text
CL.2
Code List
Fine Needle Aspiration Cytology (Circle Y or N for Yes, No)
CL Item
Y (Y)
CL Item
N (N)
C14562 (NCI Thesaurus)
Item
Core (or Tru Cut) Needle Biopsy (Circle Y or N for Yes, No)
text
CL.3
Code List
Core (or Tru Cut) Needle Biopsy (Circle Y or N for Yes, No)
CL Item
Y (Y)
CL Item
N (N)
C14562 (NCI Thesaurus)
Item
Incisional Biopsy (Circle Y or N for Yes, No)
text
CL.4
Code List
Incisional Biopsy (Circle Y or N for Yes, No)
CL Item
Y (Y)
CL Item
N (N)
C14562 (NCI Thesaurus)
Item
Excisional Biopsy or Lumpectomy (Circle Y or N for Yes, No)
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)
CL.5
Code List
Excisional Biopsy or Lumpectomy (Circle Y or N for Yes, No)
CL Item
Y (Y)
CL Item
N (N)
Item
Resection of Lumpectomy Margins (Circle Y or N for Yes, No)
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)
CL.6
Code List
Resection of Lumpectomy Margins (Circle Y or N for Yes, No)
CL Item
Y (Y)
CL Item
N (N)
Item
Sentinel Node Biopsy (Circle Y or N for Yes, No)
text
CL.7
Code List
Sentinel Node Biopsy (Circle Y or N for Yes, No)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Axillary Dissection (Circle Y or N for Yes, No)
text
CL.8
Code List
Axillary Dissection (Circle Y or N for Yes, No)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
AccessionNumber
Item
ACCESSION NUMBER (Pathology Specimen Number)
float
Item Group
Disease Description
Item
Tumor Laterality
text
CL.9
Code List
Tumor Laterality
CL Item
Left Breast (Left Breast)
CL Item
Right Breast (Right Breast)
Wasthetumorormicrocalcificationevidentonmammogram?
Item
Was the tumor or microcalcification evident on mammogram?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Was the tumor evident by ultrasound?
text
CL.11
Code List
Was the tumor evident by ultrasound?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
PalpableTumorPresentIndicator
Item
Was the tumor palpable?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25606 (NCI Thesaurus ObjectClass-2)
C0522499 (UMLS 2011AA ObjectClass-2)
Werethereanybreastsymptoms?
Item
Were there any breast symptoms? (e.g., pain, nipple discharge or retraction, skin dimpling)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item Group
Receptor Status (by Ihc)
Item
ER Status
text
CL.14
Code List
ER Status
CL Item
Negative (Negative by IHC)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive by IHC)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
PgR
text
CL.15
Code List
PgR
CL Item
Negative (Negative by IHC)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive by IHC)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Ifunknown,pleaseexplain:
Item
If unknown, please explain:
text
Item Group
Quality Of Life
DidthepatientcompletetheQualityofLifebaselineform?
Item
Did the patient complete the Quality of Life baseline form?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
If the baseline QOL form was not completed, indicate the reason below. (Protocol Approved Reasons)
text
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.17
Code List
If the baseline QOL form was not completed, indicate the reason below. (Protocol Approved Reasons)
CL Item
Patient Does Not Speak English, French, Or Spanish (Patient does not speak English, French, or Spanish)
CL Item
Patient Refused (Patient refused)
CL Item
Other Reason (Other reason)
OtherReason(ifapplicable)
Item
Other Reason (if applicable)
text
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