ID

10081

Description

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

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 3/23/15 3/23/15 - Martin Dugas
Uploaded on

March 23, 2015

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00041119

English

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1 forms  
  1. StudyEvent: CALGB: 40101 ON-STUDY FORM
    1. Continue to next page
Header
Description

Header

Alias
UMLS CUI-1
C1320722
CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID (Prior Systemic Therapy)
Description

CALGBPatientID

Data type

text

Amended data?
Description

Amendeddata?

Data type

text

Patient's Name
Description

Patient'sName

Data type

text

Participating Group
Description

ParticipatingGroup

Data type

text

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

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

MainMemberInstitution/Adjunct

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientNo.

Data type

text

Completed By (Print or Type Name)
Description

CompletedBy

Data type

text

Date Completed (M)
Description

DateCompleted

Data type

date

Patient data
Description

Patient data

Alias
UMLS CUI-1
C2707520
Menopausal Status
Description

Menopausal Status

Data type

text

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

PrimaryTumorLaterality

Data type

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)
Description

ERStatus

Data type

text

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

PgRStatus

Data type

text

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

HistologicGrade

Data type

text

HER-2 neu Status
Description

HER-2 neu Status

Data type

text

Alias
UMLS CUI-1
C0069515
Pathologic primary tumor size
Description

PathologicPrimaryTumorSize

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0475440
cm
T (disease stage, pathology report)
Description

T(diseasestage,pathologyreport)

Data type

text

N (disease stage, pathology report)
Description

N(diseasestage,pathologyreport)

Data type

text

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

M(diseasestage,pathologyreport)

Data type

text

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

PriorHormonalTherapyInd

Data type

boolean

Tamoxifen
Description

Tamoxifen

Data type

boolean

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

Raloxifene

Data type

boolean

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

Other,specify(priorhormonaltherapy)

Data type

text

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

Prioradjuvantchemotherapyforthismalignancy?

Data type

boolean

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

specify(prioradjuvantchemotherapyforthismalignancy)

Data type

text

WBC
Description

Lab,Hematology,WBC

Data type

float

Alias
UMLS CUI-1
C0023508
ANC
Description

ANC

Data type

float

Alias
UMLS CUI-1
C0948762
Platelets
Description

Platelets

Data type

float

Alias
UMLS CUI-1
C0005821
Serum Creatinine
Description

Serum Creatinine

Data type

float

Measurement units
  • mg/dl
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0201976
mg/dl
Bilirubin
Description

Lab,Hepatic,Bilirubin

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI-1
C1278039
mg/dl
Bilirubin (upper limit of normal)
Description

Bilirubin (upper limit of normal)

Data type

float

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

Dateoffirstpositivebiopsy

Data type

date

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

Typeofbiopsy

Data type

text

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

Mostextensiveprimarysurgery

Data type

text

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

PrimarySurgeryDate

Data type

date

Sentinel node biopsy
Description

Sentinelnodebiopsy

Data type

boolean

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

date(sentinelnodebiopsy)

Data type

date

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

Ifdone,sentinelnodebiopsyresults

Data type

text

Was axillary dissection performed?
Description

AxillaryDissectionInd

Data type

boolean

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

date(axillarydissectionperformed)

Data type

date

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

Totalnumberofaxillarylymphnodesexamined

Data type

float

Number of positive axillary lymph nodes
Description

Numberofpositiveaxillarylymphnodes

Data type

float

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1 forms
  1. StudyEvent: CALGB: 40101 ON-STUDY FORM
    1. Continue to next page
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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