ID

11125

Beschreibung

CALGB-10501 Chronic Lymphocytic Leukemia (CLL) Immunophenotype Form NCT00513747 Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=340EF355-2CB3-21DF-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=340EF355-2CB3-21DF-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 18.06.15 18.06.15 -
Hochgeladen am

18. Juni 2015

DOI

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Lizenz

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CALGB-10501 Chronic Lymphocytic Leukemia (CLL) Immunophenotype Form NCT00513747

Englisch

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 Formulare  
Header
Beschreibung

Header

CALGB Form
Beschreibung

Form ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Date immunophenotyping performed (MM DD YYYY)
Beschreibung

ImmunophenotypeAntigenDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20072
UMLS 2011AA ObjectClass
C0079611
NCI Metathesaurus Property
C0003320
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Beschreibung

Patient demographics

Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Immunophenotype
Beschreibung

Immunophenotype

Source of Cells used for Analysis
Beschreibung

LeukemiaSpecimenCellSourceType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C12508
UMLS 2011AA Property
C0007634
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Marrow Leukemic Cells (%)
Beschreibung

LaboratoryProcedureBoneMarrowLeukemicCellOutcomePercentageValue

Datentyp

float

Maßeinheiten
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25553
UMLS 2011AA Property-3
C1517806
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Peripheral Leukemic Cells (%)
Beschreibung

LaboratoryProcedureLeukemicCellOutcomePercentageValue

Datentyp

float

Maßeinheiten
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25553
UMLS 2011AA Property-2
C1517806
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Leukemic Cells in Other Tissue (%)
Beschreibung

LaboratoryProcedureTissueLeukemicCellOutcomePercentageValue

Datentyp

float

Maßeinheiten
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25553
UMLS 2011AA Property-3
C1517806
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
B-cell Lineage
Beschreibung

B-cell Lineage

Antigen
Beschreibung

ImmunophenotypeAntigenType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20072
UMLS 2011AA ObjectClass
C0079611
NCI Metathesaurus Property
C0003320
Other specify
Beschreibung

ImmunophenotypeAntigenSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20072
UMLS 2011AA ObjectClass
C0079611
NCI Metathesaurus Property
C0003320
Test not done
Beschreibung

Laboratory Procedure Not Performed

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Antigen percent positivity
Beschreibung

LaboratoryProcedureAntigenResultPercentageValue

Datentyp

float

Maßeinheiten
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C268
UMLS 2011AA Property-2
C0003320
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Antigen Status
Beschreibung

LaboratoryProcedureAntigenIntensityResultScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C268
UMLS 2011AA Property-2
C0003320
NCI Thesaurus Property-3
C25539
UMLS 2011AA Property-3
C0522510
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Comments
Beschreibung

Comments

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Completed by (print or type name)
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Ähnliche Modelle

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
ImmunophenotypeAntigenDate
Item
Date immunophenotyping performed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20072 (NCI Thesaurus ObjectClass)
C0079611 (UMLS 2011AA ObjectClass)
C0003320 (NCI Metathesaurus Property)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Immunophenotype
Item
Source of Cells used for Analysis
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Source of Cells used for Analysis
CL Item
Bone Marrow (Bone marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
CL Item
Peripheral Blood (Peripheral blood)
C0229664 (NCI Metathesaurus)
CL Item
Lymph Node (Lymph node)
C12745 (NCI Thesaurus)
C0024204 (UMLS 2011AA)
CL Item
Other Specify (Other)
LaboratoryProcedureBoneMarrowLeukemicCellOutcomePercentageValue
Item
Marrow Leukemic Cells (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25553 (NCI Thesaurus Property-3)
C1517806 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureLeukemicCellOutcomePercentageValue
Item
Peripheral Leukemic Cells (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25553 (NCI Thesaurus Property-2)
C1517806 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureTissueLeukemicCellOutcomePercentageValue
Item
Leukemic Cells in Other Tissue (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25553 (NCI Thesaurus Property-3)
C1517806 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Antigen
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20072 (NCI Thesaurus ObjectClass)
C0079611 (UMLS 2011AA ObjectClass)
C0003320 (NCI Metathesaurus Property)
CL.3
Code List
Antigen
CL Item
Cd10 (CD10)
CL Item
Cd19 (CD19)
CL Item
Cd20 (CD20)
CL Item
Cd21 (CD21)
CL Item
Cd22 Surface (CD22 surface)
CL Item
Cd23 (CD23)
CL Item
Cd25 (CD25)
CL Item
Cd38 (CD38)
CL Item
Cd52 (CD52)
CL Item
Cd79a Intracytoplasmic (CD79a intracytoplasmic)
CL Item
Ig-kappa Surface (Ig-kappa surface)
CL Item
Ig-lambda Surface (Ig-lambda surface)
CL Item
Igm Surface (IgM surface)
CL Item
Igd Surface (IgD surface)
CL Item
Igg Surface (IgG surface)
CL Item
Fmc-7 (FMC-7)
CL Item
Cd1a (CD1a)
CL Item
Cd2 (CD2)
CL Item
Cd3 Surface (CD3 surface)
CL Item
Cd4 (CD4)
CL Item
Cd5 (CD5)
CL Item
Cd7 (CD7)
CL Item
Cd8 (CD8)
CL Item
Cd3 Intracytoplasmic (CD3 intracytoplasmic)
CL Item
Cd4+/cd8+ (CD4+/CD8+)
CL Item
Cd11b (CD11b)
CL Item
Cd13 (CD13)
CL Item
Cd14 (CD14)
CL Item
Cd15 (CD15)
CL Item
Cd33 (CD33)
CL Item
Cd41 (CD41)
CL Item
Cd61 (CD61)
CL Item
Cd65 (CD65)
CL Item
Cd117 (CD117)
CL Item
Myeloperoxidase (Myeloperoxidase)
C0027021 (NCI Metathesaurus)
CL Item
Cd34 (CD34)
CL Item
Cd45 (CD45)
CL Item
Cd56 (CD56)
CL Item
Hla-dr (HLA-DR)
CL Item
Terminal Transferase (tdt) (Terminal Transferase (TdT))
ImmunophenotypeAntigenSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20072 (NCI Thesaurus ObjectClass)
C0079611 (UMLS 2011AA ObjectClass)
C0003320 (NCI Metathesaurus Property)
Laboratory Procedure Not Performed
Item
Test not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureAntigenResultPercentageValue
Item
Antigen percent positivity
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C268 (NCI Thesaurus Property-2)
C0003320 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Antigen Status
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C268 (NCI Thesaurus Property-2)
C0003320 (UMLS 2011AA Property-2)
C25539 (NCI Thesaurus Property-3)
C0522510 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL.4
Code List
Antigen Status
CL Item
Antigen Intensity Lab Performed, Result Negative (negative)
CL Item
Antigen Intensity Lab Performed, Result Faintly Positive (faintly positive)
CL Item
Antigen Intensity Lab Performed, Result Moderately Positive (moderately positive)
CL Item
Antigen Intensity Lab Performed, Result Strongly Positive (strongly positive)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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