ID

10285

Descrizione

E2100 On-Study Form (E2100) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC34564B-C2DB-255C-E034-0003BA12F5E7

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC34564B-C2DB-255C-E034-0003BA12F5E7

Keywords

versioni (2)
  1. 27/08/12 27/08/12 -
  2. 23/05/15 23/05/15 -
Caricato su

23 maggio 2015

DOI

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E2100 On-Study Form (E2100)

Inglese

Form No. 1575

1 moduli  
  1. StudyEvent: E2100 On-Study Form (E2100)
    1. Form No. 1575
ECOG Clinical trial administrative data
Descrizione

ECOG Clinical trial administrative data

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C16154
UMLS 2011AA ValueDomain-2
C1704379
Patient's Name
Descrizione

Patient'sName

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Participating Group Patient ID
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

Institution/Affiliate
Descrizione

MainMemberInstitution/Affiliate

Tipo di dati

text

Are data amended?
Descrizione

AmendedDataInd

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient Characteristics
Descrizione

Patient Characteristics

Menopausal Status (Choose one:)
Descrizione

MenopausalStatus

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Advanced Disease Description
Descrizione

Advanced Disease Description

ER Status (most recent)
Descrizione

ERStatus

Tipo di dati

text

Receptor Status Timing (most recent)
Descrizione

ReceptorStatusTiming

Tipo di dati

text

ER Timing, Other, Specify
Descrizione

ERTiming,Other

Tipo di dati

text

PgR Status (most recent)
Descrizione

PgRStatus

Tipo di dati

text

PgR Timing, Other, Specify
Descrizione

PgRTiming,Other

Tipo di dati

text

Her2/Neu expression status by immunohistochemistry (Choose one:)
Descrizione

Her2/Neuexpressionstatusbyimmunohistochemistry

Tipo di dati

text

Her2/Neu expression status by FISH (Choose one:)
Descrizione

Her2/NeuexpressionstatusbyFISH

Tipo di dati

text

Date of Initial Diagnosis of Primary Tumor (M D Y)
Descrizione

FirstPositiveBiopsyDate

Tipo di dati

date

Date Recurrent, Progressive, or Metastatic Disease First Diagnosed (M D Y)
Descrizione

DateRecurrent,Progressive,orMetastaticDiseaseFirstDiagnosed

Tipo di dati

date

Site(s) Of Involvement
Descrizione

Site(s) Of Involvement

Local-regional (sites of involvement) (Circle the involved local-regional sites listed in below:)
Descrizione

Local-regional(sitesofinvolvement)

Tipo di dati

text

Ipsilateral supraclavicular nodes (sites of involvement)
Descrizione

Ipsilateralsupraclavicularnodes(sitesofinvolvement)

Tipo di dati

boolean

Opposite breast (sites of involvement)
Descrizione

Oppositebreast(sitesofinvolvement)

Tipo di dati

boolean

Distant nodes (sites of involvement)
Descrizione

Distantnodes(sitesofinvolvement)

Tipo di dati

boolean

Distant skin/subcutaneous tissue (sites of involvement)
Descrizione

Distantskin/subcutaneoustissue(sitesofinvolvement)

Tipo di dati

boolean

Bone (sites of involvement)
Descrizione

Bone(sitesofinvolvement)

Tipo di dati

boolean

Bone marrow (sites of involvement)
Descrizione

Bonemarrow(sitesofinvolvement)

Tipo di dati

boolean

Lung (sites of involvement)
Descrizione

Lung(sitesofinvolvement)

Tipo di dati

boolean

Liver (sites of involvement)
Descrizione

Liver(sitesofinvolvement)

Tipo di dati

boolean

Pleura (sites of involvement)
Descrizione

Pleura(sitesofinvolvement)

Tipo di dati

boolean

Brain (sites of involvement)
Descrizione

Brain(sitesofinvolvement)

Tipo di dati

boolean

Other CNS (sites of involvement)
Descrizione

OtherCNS(sitesofinvolvement)

Tipo di dati

boolean

First Other, specify (sites of involvement)
Descrizione

FirstOther,specify(sitesofinvolvement)

Tipo di dati

boolean

Second Other, specify (sites of involvement)
Descrizione

SecondOther,specify(sitesofinvolvement)

Tipo di dati

boolean

First Other, specify
Descrizione

FirstOther,specify

Tipo di dati

text

Second Other, specify
Descrizione

SecondOther,specify

Tipo di dati

text

Prior Systemic Therapy
Descrizione

Prior Systemic Therapy

Prior Adjuvant Hormonal Therapy? (do not include steroids given with chemotherapy)
Descrizione

PriorAdjuvantHormonalTherapyInd

Tipo di dati

boolean

Prior Metastatic/Recurrent Hormonal Therapy? (do not include steroids given with chemotherapy)
Descrizione

PriorMetastatic/RecurrentHormonalTherapyInd

Tipo di dati

boolean

Prior Adjuvant Chemotherapy? (include pre-op chemotherapy at diagnosis)
Descrizione

PriorAdjuvantChemotherapyInd

Tipo di dati

boolean

Prior Chemotherapy for Metastasis or Recurrence?
Descrizione

PriorMetastatic/RecurrentChemotherapyInd

Tipo di dati

boolean

Prior Adjuvant High Dose Chemotherapy/Autologous Stem Cell Transplant?
Descrizione

PriorAdjuvantHighDoseChemotherapy/AutologousStemCellTransplant?

Tipo di dati

boolean

Prior High Dose Chemotherapy/Autologous Stem Cell Transplant for Metastasis or Recurrence?
Descrizione

PriorHighDoseChemotherapy/AutologousStemCellTransplantforMetastasisorRecurrence?

Tipo di dati

boolean

Prior Adjuvant Immunotherapy?
Descrizione

PriorAdjuvantImmunotherapyInd

Tipo di dati

boolean

Prior Immunotherapy for Metastasis or Recurrence?
Descrizione

PriorMetastatic/RecurrentImmunotherapyInd

Tipo di dati

boolean

Prior Adjuvant Other Therapy?
Descrizione

PriorAdjuvantOtherTherapyInd

Tipo di dati

boolean

Prior Metastatic/Recurrent Other Therapy?
Descrizione

PriorMetastatic/RecurrentOtherTherapyInd

Tipo di dati

boolean

Prior Systemic Regimens
Descrizione

Prior Systemic Regimens

Prior Treatment Regimen Name(s)
Descrizione

PriorTreatmentRegimenName(s)

Tipo di dati

text

Prior Treatment Regimen Start Date (M/D/Y)
Descrizione

PriorTreatmentRegimenBeginDate

Tipo di dati

date

Prior Treatment Regimen End Date (M/D/Y)
Descrizione

PriorTreatmentRegimenEndDate

Tipo di dati

date

Prior Treatment Regimen Type
Descrizione

PriorTreatmentRegimenType

Tipo di dati

text

Comments
Descrizione

Comments

Comments
Descrizione

Comments

Tipo di dati

text

Investigator Signature
Descrizione

InvestigatorSignature

Tipo di dati

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Descrizione

Date

Tipo di dati

text

Ccrr Module For E2100 On-study Form (e2100)
Descrizione

Ccrr Module For E2100 On-study Form (e2100)

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Similar models

Form No. 1575

1 moduli
  1. StudyEvent: E2100 On-Study Form (E2100)
    1. Form No. 1575
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
ECOG Clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16154 (NCI Thesaurus ValueDomain-2)
C1704379 (UMLS 2011AA ValueDomain-2)
Patient'sName
Item
Patient's Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Patient Characteristics
Item
Menopausal Status (Choose one:)
text
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.2
Code List
Menopausal Status (Choose one:)
CL Item
Pre (Pre)
CL Item
Post (Post)
C38008 (NCI Thesaurus)
C0687676 (UMLS 2011AA)
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 Group
Advanced Disease Description
Item
ER Status (most recent)
text
CL.3
Code List
ER Status (most recent)
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 Timing (most recent)
text
CL.6
Code List
Receptor Status Timing (most recent)
CL Item
Initial Diagnosis (Initial Diagnosis)
CL Item
At Recurrence (At Recurrence)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ERTiming,Other
Item
ER Timing, Other, Specify
text
Item
PgR Status (most recent)
text
CL.5
Code List
PgR Status (most recent)
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)
PgRTiming,Other
Item
PgR Timing, Other, Specify
text
Item
Her2/Neu expression status by immunohistochemistry (Choose one:)
text
CL.7
Code List
Her2/Neu expression status by immunohistochemistry (Choose one:)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
Item
Her2/Neu expression status by FISH (Choose one:)
text
CL.8
Code List
Her2/Neu expression status by FISH (Choose one:)
CL Item
Non-amplified (Non-amplified)
CL Item
Amplified (Amplified)
CL Item
8 (8)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
FirstPositiveBiopsyDate
Item
Date of Initial Diagnosis of Primary Tumor (M D Y)
date
DateRecurrent,Progressive,orMetastaticDiseaseFirstDiagnosed
Item
Date Recurrent, Progressive, or Metastatic Disease First Diagnosed (M D Y)
date
Item Group
Site(s) Of Involvement
Item
Local-regional (sites of involvement) (Circle the involved local-regional sites listed in below:)
text
CL.23
Code List
Local-regional (sites of involvement) (Circle the involved local-regional sites listed in below:)
CL Item
ipsilateraly breast (ipsilateraly breast)
CL Item
chest wall (chest wall)
CL Item
axillary, internal mammary and infraclavicular nodes (axillary, internal mammary and infraclavicular nodes)
CL Item
local regional skin and subcutaneous tissue (local regional skin and subcutaneous tissue)
Ipsilateralsupraclavicularnodes(sitesofinvolvement)
Item
Ipsilateral supraclavicular nodes (sites of involvement)
boolean
Oppositebreast(sitesofinvolvement)
Item
Opposite breast (sites of involvement)
boolean
Distantnodes(sitesofinvolvement)
Item
Distant nodes (sites of involvement)
boolean
Distantskin/subcutaneoustissue(sitesofinvolvement)
Item
Distant skin/subcutaneous tissue (sites of involvement)
boolean
Bone(sitesofinvolvement)
Item
Bone (sites of involvement)
boolean
Bonemarrow(sitesofinvolvement)
Item
Bone marrow (sites of involvement)
boolean
Lung(sitesofinvolvement)
Item
Lung (sites of involvement)
boolean
Liver(sitesofinvolvement)
Item
Liver (sites of involvement)
boolean
Pleura(sitesofinvolvement)
Item
Pleura (sites of involvement)
boolean
Brain(sitesofinvolvement)
Item
Brain (sites of involvement)
boolean
OtherCNS(sitesofinvolvement)
Item
Other CNS (sites of involvement)
boolean
FirstOther,specify(sitesofinvolvement)
Item
First Other, specify (sites of involvement)
boolean
SecondOther,specify(sitesofinvolvement)
Item
Second Other, specify (sites of involvement)
boolean
FirstOther,specify
Item
First Other, specify
text
SecondOther,specify
Item
Second Other, specify
text
Item Group
Prior Systemic Therapy
PriorAdjuvantHormonalTherapyInd
Item
Prior Adjuvant Hormonal Therapy? (do not include steroids given with chemotherapy)
boolean
PriorMetastatic/RecurrentHormonalTherapyInd
Item
Prior Metastatic/Recurrent Hormonal Therapy? (do not include steroids given with chemotherapy)
boolean
PriorAdjuvantChemotherapyInd
Item
Prior Adjuvant Chemotherapy? (include pre-op chemotherapy at diagnosis)
boolean
PriorMetastatic/RecurrentChemotherapyInd
Item
Prior Chemotherapy for Metastasis or Recurrence?
boolean
PriorAdjuvantHighDoseChemotherapy/AutologousStemCellTransplant?
Item
Prior Adjuvant High Dose Chemotherapy/Autologous Stem Cell Transplant?
boolean
PriorHighDoseChemotherapy/AutologousStemCellTransplantforMetastasisorRecurrence?
Item
Prior High Dose Chemotherapy/Autologous Stem Cell Transplant for Metastasis or Recurrence?
boolean
PriorAdjuvantImmunotherapyInd
Item
Prior Adjuvant Immunotherapy?
boolean
PriorMetastatic/RecurrentImmunotherapyInd
Item
Prior Immunotherapy for Metastasis or Recurrence?
boolean
PriorAdjuvantOtherTherapyInd
Item
Prior Adjuvant Other Therapy?
boolean
PriorMetastatic/RecurrentOtherTherapyInd
Item
Prior Metastatic/Recurrent Other Therapy?
boolean
Item Group
Prior Systemic Regimens
PriorTreatmentRegimenName(s)
Item
Prior Treatment Regimen Name(s)
text
PriorTreatmentRegimenBeginDate
Item
Prior Treatment Regimen Start Date (M/D/Y)
date
PriorTreatmentRegimenEndDate
Item
Prior Treatment Regimen End Date (M/D/Y)
date
Item
Prior Treatment Regimen Type
text
CL.34
Code List
Prior Treatment Regimen Type
CL Item
Adjuvant (adjuvant)
C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)
CL Item
Neoadjuvant (neoadjuvant)
CL Item
Advanced (advanced)
C25411 (NCI Thesaurus)
C0205179 (UMLS 2011AA)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Date
Item
Date
text
Item Group
Ccrr Module For E2100 On-study Form (e2100)
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