ID

753

Beschrijving

CALGB: 40101 ON-STUDY FORM Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer 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

Trefwoorden

Versies (2)
  1. 26-08-12 26-08-12 -
  2. 23-03-15 23-03-15 - Martin Dugas
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26 augustus 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00041119 On-Study - CALGB: 40101 ON-STUDY FORM - 2040995v3.0

Engels

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1 Formulieren  
  1. StudyEvent: CALGB: 40101 ON-STUDY FORM
    1. Continue to next page
Unnamed1
Beschrijving

Unnamed1

CALGB Form
Beschrijving

CALGBForm

Datatype

text

CALGB Study No
Beschrijving

CALGBStudyNo

Datatype

text

CALGB Patient ID (Prior Systemic Therapy)
Beschrijving

CALGBPatientID

Datatype

text

Amended data?
Beschrijving

Amendeddata?

Datatype

text

Unnamed2
Beschrijving

Unnamed2

Patient's Name
Beschrijving

Patient'sName

Datatype

text

Participating Group
Beschrijving

ParticipatingGroup

Datatype

text

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

PatientHospitalNumber

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Main Member Institution/Adjunct
Beschrijving

MainMemberInstitution/Adjunct

Datatype

text

Participating Group Patient No.
Beschrijving

ParticipatingGroupPatientNo.

Datatype

text

Unnamed3
Beschrijving

Unnamed3

Menopausal Status (mark one with an X)
Beschrijving

MenopausalStatus

Datatype

text

Tumor Laterality (mark one with an X)
Beschrijving

PrimaryTumorLaterality

Datatype

text

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)
Beschrijving

ERStatus

Datatype

text

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

PgRStatus

Datatype

text

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

HistologicGrade

Datatype

text

HER-2 neu Status (mark one with an X)
Beschrijving

HER-2neuStatus

Datatype

text

Pathologic primary tumor size (cm)
Beschrijving

PathologicPrimaryTumorSize

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
T (disease stage, pathology report)
Beschrijving

T(diseasestage,pathologyreport)

Datatype

text

N (disease stage, pathology report)
Beschrijving

N(diseasestage,pathologyreport)

Datatype

text

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

M(diseasestage,pathologyreport)

Datatype

text

Unnamed4
Beschrijving

Unnamed4

Patient's Name
Beschrijving

Patient'sName

Datatype

text

CALGB Form
Beschrijving

CALGBForm

Datatype

text

CALGB Study No
Beschrijving

CALGBStudyNo

Datatype

text

CALGB Patient ID (Prior Systemic Therapy)
Beschrijving

CALGBPatientID

Datatype

text

Unnamed5
Beschrijving

Unnamed5

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

PriorHormonalTherapyInd

Datatype

text

Tamoxifen
Beschrijving

Tamoxifen

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Raloxifene
Beschrijving

Raloxifene

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Other, specify (prior hormonal therapy)
Beschrijving

Other,specify(priorhormonaltherapy)

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Other, specify (prior hormonal therapy)
Beschrijving

Other,specify(priorhormonaltherapy)

Datatype

text

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

Prioradjuvantchemotherapyforthismalignancy?

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
specify (prior adjuvant chemotherapy for this malignancy) (Required Pre-Study Laboratory Values)
Beschrijving

specify(prioradjuvantchemotherapyforthismalignancy)

Datatype

text

WBC
Beschrijving

Lab,Hematology,WBC

Datatype

double

ANC
Beschrijving

ANC

Datatype

double

Platelets
Beschrijving

PlATELETS

Datatype

text

Serum Creatinine (mg/dl)
Beschrijving

SerumCreatinine

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Bilirubin (mg/dl)
Beschrijving

Lab,Hepatic,Bilirubin

Datatype

double

Bilirubin (upper limit of normal)
Beschrijving

Bilirubin

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Unnamed6
Beschrijving

Unnamed6

Date of first positive biopsy (M)
Beschrijving

Dateoffirstpositivebiopsy

Datatype

date

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

Typeofbiopsy

Datatype

text

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

Mostextensiveprimarysurgery

Datatype

text

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

PrimarySurgeryDate

Datatype

date

Sentinel node biopsy
Beschrijving

Sentinelnodebiopsy

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
date (sentinel node biopsy) (M)
Beschrijving

date(sentinelnodebiopsy)

Datatype

date

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

Ifdone,sentinelnodebiopsyresults

Datatype

text

Was axillary dissection performed?
Beschrijving

AxillaryDissectionInd

Datatype

text

date (axillary dissection performed) (M)
Beschrijving

date(axillarydissectionperformed)

Datatype

date

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

Totalnumberofaxillarylymphnodesexamined

Datatype

double

Number of positive axillary lymph nodes
Beschrijving

Numberofpositiveaxillarylymphnodes

Datatype

double

Completed By (Print or Type Name)
Beschrijving

CompletedBy

Datatype

text

Date Completed (M)
Beschrijving

DateCompleted

Datatype

date

Ccrr Module For Calgb: 40101 On-study Form
Beschrijving

Ccrr Module For Calgb: 40101 On-study Form

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1 Formulieren
  1. StudyEvent: CALGB: 40101 ON-STUDY FORM
    1. Continue to next page
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
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)
Item Group
Unnamed2
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
Item Group
Unnamed3
Item
Menopausal Status (mark one with an X)
text
CL.2
Code List
Menopausal Status (mark one with an X)
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
Above Categories Not Applicable And Age => 50 (Above categories not applicable AND Age >=50)
Item
Tumor Laterality (mark one with an X)
text
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 (mark one with an X)
text
CL.7
Code List
HER-2 neu Status (mark one with an X)
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)
PathologicPrimaryTumorSize
Item
Pathologic primary tumor size (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
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
Item Group
Unnamed4
Patient'sName
Item
Patient's Name
text
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID (Prior Systemic Therapy)
text
Item Group
Unnamed5
Item
Prior hormonal therapy? (do not include steroids given with chemotherapy)
text
CL.8
Code List
Prior hormonal therapy? (do not include steroids given with chemotherapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Tamoxifen
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.9
Code List
Tamoxifen
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Raloxifene
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.10
Code List
Raloxifene
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Other,specify(priorhormonaltherapy)
Item
Other, specify (prior hormonal therapy)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Other,specify(priorhormonaltherapy)
Item
Other, specify (prior hormonal therapy)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Prior adjuvant chemotherapy for this malignancy? (include pre-op chemotherapy at diagnosis)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
Code List
Prior adjuvant chemotherapy for this malignancy? (include pre-op chemotherapy at diagnosis)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
specify(prioradjuvantchemotherapyforthismalignancy)
Item
specify (prior adjuvant chemotherapy for this malignancy) (Required Pre-Study Laboratory Values)
text
Lab,Hematology,WBC
Item
WBC
double
ANC
Item
ANC
double
PlATELETS
Item
Platelets
text
SerumCreatinine
Item
Serum Creatinine (mg/dl)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Lab,Hepatic,Bilirubin
Item
Bilirubin (mg/dl)
double
Bilirubin
Item
Bilirubin (upper limit of normal)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item Group
Unnamed6
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
Item
Sentinel node biopsy
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.15
Code List
Sentinel node biopsy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
Item
Was axillary dissection performed?
text
CL.17
Code List
Was axillary dissection performed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
double
Numberofpositiveaxillarylymphnodes
Item
Number of positive axillary lymph nodes
double
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed (M)
date
Item Group
Ccrr Module For Calgb: 40101 On-study Form
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