ID

10081

Descrição

CALGB: 40101 ON-STUDY FORM Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer NCT00041119 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4E097B4-CDDD-18B4-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4E097B4-CDDD-18B4-E034-080020C9C0E0

Palavras-chave

Versões (2)
  1. 26/08/2012 26/08/2012 -
  2. 23/03/2015 23/03/2015 - Martin Dugas
Transferido a

23 de março de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00041119

Inglês

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1 Formulários  
  1. StudyEvent: CALGB: 40101 ON-STUDY FORM
    1. Continue to next page
Header
Descrição

Header

Alias
UMLS CUI-1
C1320722
CALGB Form
Descrição

CALGBForm

Tipo de dados

text

CALGB Study No
Descrição

CALGBStudyNo

Tipo de dados

text

CALGB Patient ID (Prior Systemic Therapy)
Descrição

CALGBPatientID

Tipo de dados

text

Amended data?
Descrição

Amendeddata?

Tipo de dados

text

Patient's Name
Descrição

Patient'sName

Tipo de dados

text

Participating Group
Descrição

ParticipatingGroup

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Descrição

PatientHospitalNumber

Tipo de dados

text

Participating Group Protocol No.
Descrição

ParticipatingGroupProtocolNo.

Tipo de dados

text

Main Member Institution/Adjunct
Descrição

MainMemberInstitution/Adjunct

Tipo de dados

text

Participating Group Patient No.
Descrição

ParticipatingGroupPatientNo.

Tipo de dados

text

Completed By (Print or Type Name)
Descrição

CompletedBy

Tipo de dados

text

Date Completed (M)
Descrição

DateCompleted

Tipo de dados

date

Patient data
Descrição

Patient data

Alias
UMLS CUI-1
C2707520
Menopausal Status
Descrição

Menopausal Status

Tipo de dados

text

Alias
UMLS CUI-1
C0455962
Tumor Laterality (mark one with an X)
Descrição

PrimaryTumorLaterality

Tipo de dados

text

Alias
UMLS CUI-1
C0441987
UMLS CUI-2
C0475445
Receptor Status, ER (If measured in fmols/mg cytosol protein >= 10 is positive. If other measures are used apply institutional standards; borderline results should be reported as positive)
Descrição

ERStatus

Tipo de dados

text

Receptor Status, PgR (mark one with an X)
Descrição

PgRStatus

Tipo de dados

text

Histologic Grade (combined histologic grade is used according to SBR/ELSTON classification.)
Descrição

HistologicGrade

Tipo de dados

text

HER-2 neu Status
Descrição

HER-2 neu Status

Tipo de dados

text

Alias
UMLS CUI-1
C0069515
Pathologic primary tumor size
Descrição

PathologicPrimaryTumorSize

Tipo de dados

float

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0475440
cm
T (disease stage, pathology report)
Descrição

T(diseasestage,pathologyreport)

Tipo de dados

text

N (disease stage, pathology report)
Descrição

N(diseasestage,pathologyreport)

Tipo de dados

text

M (disease stage, pathology report) (Disease stage pathology report)
Descrição

M(diseasestage,pathologyreport)

Tipo de dados

text

Prior hormonal therapy? (do not include steroids given with chemotherapy)
Descrição

PriorHormonalTherapyInd

Tipo de dados

boolean

Tamoxifen
Descrição

Tamoxifen

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0039286
Raloxifene
Descrição

Raloxifene

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0244404
Other, specify (prior hormonal therapy)
Descrição

Other,specify(priorhormonaltherapy)

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Prior adjuvant chemotherapy for this malignancy? (include pre-op chemotherapy at diagnosis)
Descrição

Prioradjuvantchemotherapyforthismalignancy?

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
specify (prior adjuvant chemotherapy for this malignancy)
Descrição

specify(prioradjuvantchemotherapyforthismalignancy)

Tipo de dados

text

WBC
Descrição

Lab,Hematology,WBC

Tipo de dados

float

Alias
UMLS CUI-1
C0023508
ANC
Descrição

ANC

Tipo de dados

float

Alias
UMLS CUI-1
C0948762
Platelets
Descrição

Platelets

Tipo de dados

float

Alias
UMLS CUI-1
C0005821
Serum Creatinine
Descrição

Serum Creatinine

Tipo de dados

float

Unidades de medida
  • mg/dl
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0201976
mg/dl
Bilirubin
Descrição

Lab,Hepatic,Bilirubin

Tipo de dados

float

Unidades de medida
  • mg/dl
Alias
UMLS CUI-1
C1278039
mg/dl
Bilirubin (upper limit of normal)
Descrição

Bilirubin (upper limit of normal)

Tipo de dados

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0201913
UMLS CUI-2
C1519815
Date of first positive biopsy (M)
Descrição

Dateoffirstpositivebiopsy

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Type of biopsy (mark one with an X)
Descrição

Typeofbiopsy

Tipo de dados

text

Most extensive primary surgery (mark one with an X)
Descrição

Mostextensiveprimarysurgery

Tipo de dados

text

Date of most extensive primary surgery (if required, use date of last re-excision)
Descrição

PrimarySurgeryDate

Tipo de dados

date

Sentinel node biopsy
Descrição

Sentinelnodebiopsy

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0796693
date (sentinel node biopsy) (M)
Descrição

date(sentinelnodebiopsy)

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
If done, sentinel node biopsy results (per protocol)
Descrição

Ifdone,sentinelnodebiopsyresults

Tipo de dados

text

Was axillary dissection performed?
Descrição

AxillaryDissectionInd

Tipo de dados

boolean

Alias
UMLS CUI-1
C0193867
date (axillary dissection performed) (M)
Descrição

date(axillarydissectionperformed)

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Total number of axillary lymph nodes examined
Descrição

Totalnumberofaxillarylymphnodesexamined

Tipo de dados

float

Number of positive axillary lymph nodes
Descrição

Numberofpositiveaxillarylymphnodes

Tipo de dados

float

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1 Formulários
  1. StudyEvent: CALGB: 40101 ON-STUDY FORM
    1. Continue to next page
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID (Prior Systemic Therapy)
text
Item
Amended data?
text
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed (M)
date
Item Group
Patient data
C2707520 (UMLS CUI-1)
Item
Menopausal Status
text
C0455962 (UMLS CUI-1)
CL.2
Code List
Menopausal Status
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre)
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post)
CL Item
Above Categories Not Applicable And Age < 50 (Above categories not applicable AND Age <50)
CL Item
50 (Above categories not applicable AND Age >)
Item
Tumor Laterality (mark one with an X)
text
C0441987 (UMLS CUI-1)
C0475445 (UMLS CUI-2)
CL.3
Code List
Tumor Laterality (mark one with an X)
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
Item
Receptor Status, ER (If measured in fmols/mg cytosol protein >= 10 is positive. If other measures are used apply institutional standards; borderline results should be reported as positive)
text
CL.4
Code List
Receptor Status, ER (If measured in fmols/mg cytosol protein >= 10 is positive. If other measures are used apply institutional standards; borderline results should be reported as positive)
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
Receptor Status, PgR (mark one with an X)
text
CL.5
Code List
Receptor Status, PgR (mark one with an X)
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
Histologic Grade (combined histologic grade is used according to SBR/ELSTON classification.)
text
CL.6
Code List
Histologic Grade (combined histologic grade is used according to SBR/ELSTON classification.)
CL Item
Well Differentiated (Low)
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderately Differentiated (Intermediate)
C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)
CL Item
Poorly Differentiated (High)
C14167 (NCI Thesaurus)
C0205617 (UMLS 2011AA)
Item
HER-2 neu Status
text
C0069515 (UMLS CUI-1)
CL.7
Code List
HER-2 neu Status
CL Item
Dako Herceptest 3+ (Dako Herceptest 3+)
CL Item
Dako Herceptest <3+/fish+ (Dako Herceptest <3+/FISH+)
CL Item
Unknown (Unknown)
CL Item
Not done (Not done)
CL Item
Fish+ (ihc Not Done) (FISH+ (IHC not done))
CL Item
Ihc (non-dako Herceptest) Strong Positive (IHC (non-Dako Herceptest) strong positive)
CL Item
Negative (Negative)
Tumor size
Item
Pathologic primary tumor size
float
C25209 (NCI Thesaurus ValueDomain)
C0475440 (UMLS CUI-1)
T(diseasestage,pathologyreport)
Item
T (disease stage, pathology report)
text
N(diseasestage,pathologyreport)
Item
N (disease stage, pathology report)
text
M(diseasestage,pathologyreport)
Item
M (disease stage, pathology report) (Disease stage pathology report)
text
PriorHormonalTherapyInd
Item
Prior hormonal therapy? (do not include steroids given with chemotherapy)
boolean
Tamoxifen
Item
Tamoxifen
boolean
C25180 (NCI Thesaurus ValueDomain)
C0039286 (UMLS CUI-1)
Raloxifene
Item
Raloxifene
boolean
C25180 (NCI Thesaurus ValueDomain)
C0244404 (UMLS CUI-1)
Other,specify(priorhormonaltherapy)
Item
Other, specify (prior hormonal therapy)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Prioradjuvantchemotherapyforthismalignancy?
Item
Prior adjuvant chemotherapy for this malignancy? (include pre-op chemotherapy at diagnosis)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
prior adjuvant chemotherapy, specify
Item
specify (prior adjuvant chemotherapy for this malignancy)
text
WBC
Item
WBC
float
C0023508 (UMLS CUI-1)
ANC
Item
ANC
float
C0948762 (UMLS CUI-1)
Platelets
Item
Platelets
float
C0005821 (UMLS CUI-1)
SerumCreatinine
Item
Serum Creatinine
float
C25209 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI-1)
Bilirubin
Item
Bilirubin
float
C1278039 (UMLS CUI-1)
Bilirubin ULN
Item
Bilirubin (upper limit of normal)
float
C25209 (NCI Thesaurus ValueDomain)
C0201913 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Dateoffirstpositivebiopsy
Item
Date of first positive biopsy (M)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Type of biopsy (mark one with an X)
text
CL.13
Code List
Type of biopsy (mark one with an X)
CL Item
Core Needle (Core needle)
CL Item
Incisional (Incisional)
CL Item
Excisional (Excisional)
Item
Most extensive primary surgery (mark one with an X)
text
CL.14
Code List
Most extensive primary surgery (mark one with an X)
CL Item
Partial Mastectomy/lumpectomy/excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
PrimarySurgeryDate
Item
Date of most extensive primary surgery (if required, use date of last re-excision)
date
Sentinel node biopsy
Item
Sentinel node biopsy
boolean
C25180 (NCI Thesaurus ValueDomain)
C0796693 (UMLS CUI-1)
date(sentinelnodebiopsy)
Item
date (sentinel node biopsy) (M)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
If done, sentinel node biopsy results (per protocol)
text
CL.16
Code List
If done, sentinel node biopsy results (per protocol)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Axillary Dissection
Item
Was axillary dissection performed?
boolean
C0193867 (UMLS CUI-1)
date(axillarydissectionperformed)
Item
date (axillary dissection performed) (M)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Totalnumberofaxillarylymphnodesexamined
Item
Total number of axillary lymph nodes examined
float
Numberofpositiveaxillarylymphnodes
Item
Number of positive axillary lymph nodes
float
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