ID

41532

Descripción

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Palabras clave

Versiones (2)
  1. 26/10/20 26/10/20 -
  2. 2/11/20 2/11/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

2 de noviembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

Inglés

Laboratory (Report Final and Annex Report 2 Final)

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Centre number
Descripción

Centre number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
MAGE-A3 Expression Test: Screening
Descripción

MAGE-A3 Expression Test: Screening

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0220908
Was a fresh tumor sample received for MAGE-A3 expression?
Descripción

Was a fresh tumor sample received for MAGE-A3 expression?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2827486
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
Date of reception
Descripción

Date of reception

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0544683
UMLS CUI [1,2]
C0011008
Date of patient’s birth
Descripción

Date of patient’s birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Requisition number
Descripción

Requisition number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0237753
Date of result
Descripción

Date of result

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0011008
Sample not valid
Descripción

Sample not valid

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1519941
Specify other reason for sample not valid
Descripción

Specify other reason for sample not valid

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1519941
UMLS CUI [2]
C3840932
Quantity RNA
Descripción

Quantity RNA

Tipo de datos

float

Unidades de medida
  • ug
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0035668
ug
Quality of RNA
Descripción

Quality of RNA

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0035668
UMLS CUI [1,2]
C0332306
Biopsy amount
Descripción

Biopsy amount

Tipo de datos

integer

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1561574
mg
MAGE-A3 Expression Test: Screening - Result
Descripción

MAGE-A3 Expression Test: Screening - Result

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0220908
UMLS CUI-5
C1274040
Biopsy - Ct Mage-A3 Result 1
Descripción

Biopsy - Ct Mage-A3 Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0962473
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Mage-A3 Result 2
Descripción

Biopsy - Ct Mage-A3 Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0962473
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Beta Actin Result 1
Descripción

Biopsy - Ct Beta Actin Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0005186
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Beta Actin Result 2
Descripción

Biopsy - Ct Beta Actin Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0005186
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Positive Control (diluted 100x) - Ct Mage A3 Result 1
Descripción

Positive Control (diluted 100x) - Ct Mage A3 Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0962473
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 100x) - Ct Mage A3 Result 2
Descripción

Positive Control (diluted 100x) - Ct Mage A3 Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0962473
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 1x) - Ct Beta Actin Result 1
Descripción

Positive Control (diluted 1x) - Ct Beta Actin Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0005186
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 1x) - Ct Beta Actin Result 2
Descripción

Positive Control (diluted 1x) - Ct Beta Actin Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0005186
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
MAGE-A3 Expression Test: Screening - Result
Descripción

MAGE-A3 Expression Test: Screening - Result

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0220908
UMLS CUI-5
C1274040
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Percentage of Positive Control
Descripción

Percentage of Positive Control

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0439165
UMLS CUI [2]
C1883676
%
Mage-A3 Result
Descripción

Mage-A3 Result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0962473
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C1274040
Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening)
Descripción

Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening)

Alias
UMLS CUI-1
C1550483
UMLS CUI-2
C0022877
UMLS CUI-3
C0962473
UMLS CUI-4
C0017262
UMLS CUI-5
C0022885
UMLS CUI-6
C0220908
Investigator's signature
Descripción

I confirm that I have reviewed the data in this Case Report Form for this Patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature date
Descripción

Investigator's signature date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
MAGE-A3 Expression Test: Screening (Re-Test)
Descripción

MAGE-A3 Expression Test: Screening (Re-Test)

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0220908
UMLS CUI-5
C0205341
Was a fresh tumor sample received for MAGE-A3 expression?
Descripción

Was a fresh tumor sample received for MAGE-A3 expression?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2827486
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
Date of reception
Descripción

Date of reception

Tipo de datos

date

Alias
UMLS CUI [1]
C0544683
UMLS CUI [2]
C0011008
Date of patient’s birth
Descripción

Date of patient’s birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Requisition number
Descripción

Requisition number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0237753
Date of result
Descripción

Date of result

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0011008
Sample not valid
Descripción

Sample not valid

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1519941
Specify other reason for sample not valid
Descripción

Specify other reason for sample not valid

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1519941
UMLS CUI [2]
C3840932
Quantity RNA
Descripción

Quantity RNA

Tipo de datos

float

Unidades de medida
  • ug
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0035668
ug
Quality of RNA
Descripción

Quality of RNA

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0035668
UMLS CUI [1,2]
C0332306
Biopsy amount
Descripción

Biopsy amount

Tipo de datos

integer

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1561574
mg
MAGE-A3 Expression Test: Screening (Re-Test) - Result
Descripción

MAGE-A3 Expression Test: Screening (Re-Test) - Result

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0220908
UMLS CUI-5
C0205341
UMLS CUI-6
C1274040
Biopsy - Ct Mage-A3 Result 1
Descripción

Biopsy - Ct Mage-A3 Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0962473
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Mage-A3 Result 2
Descripción

Biopsy - Ct Mage-A3 Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0962473
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Beta Actin Result 1
Descripción

Biopsy - Ct Beta Actin Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0005186
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Beta Actin Result 2
Descripción

Biopsy - Ct Beta Actin Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0005186
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Positive Control (diluted 100x) - Ct Mage A3 Result 1
Descripción

Positive Control (diluted 100x) - Ct Mage A3 Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0962473
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 100x) - Ct Mage A3 Result 2
Descripción

Positive Control (diluted 100x) - Ct Mage A3 Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0962473
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 1x) - Ct Beta Actin Result 1
Descripción

Positive Control (diluted 1x) - Ct Beta Actin Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0005186
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 1x) - Ct Beta Actin Result 2
Descripción

Positive Control (diluted 1x) - Ct Beta Actin Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0005186
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
MAGE-A3 Expression Test: Screening (Re-Test) - Result
Descripción

MAGE-A3 Expression Test: Screening (Re-Test) - Result

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0220908
UMLS CUI-5
C0205341
UMLS CUI-6
C1274040
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Percentage of Positive Control
Descripción

Percentage of Positive Control

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0439165
UMLS CUI [2]
C1883676
%
Mage-A3 Result
Descripción

Mage-A3 Result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0962473
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C1274040
Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening (Re-Test))
Descripción

Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening (Re-Test))

Alias
UMLS CUI-1
C1550483
UMLS CUI-2
C0022877
UMLS CUI-3
C0962473
UMLS CUI-4
C0017262
UMLS CUI-5
C0022885
UMLS CUI-6
C0205341
UMLS CUI-7
C0220908
Investigator's signature
Descripción

I confirm that I have reviewed the data in this Case Report Form for this Patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature date
Descripción

Investigator's signature date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Gene Profiling: Screening
Descripción

Gene Profiling: Screening

Alias
UMLS CUI-1
C0752248
UMLS CUI-2
C0220908
Requisition number
Descripción

Requisition number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0237753
Has the fresh tumor sample been tested for gene profiling?
Descripción

Has the fresh tumor sample been tested for gene profiling?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
If the fresh tumor sample has not been tested for gene profiling, specify reason
Descripción

If the fresh tumor sample has not been tested for gene profiling, specify reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
UMLS CUI [4]
C0392360
If the fresh tumor sample has not been tested for gene profiling, specify other reason
Descripción

If the fresh tumor sample has not been tested for gene profiling, specify other reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
UMLS CUI [4]
C3840932
If the fresh tumor sample has been tested for gene profiling, record date of result
Descripción

If the fresh tumor sample has been tested for gene profiling, record date of result

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
UMLS CUI [4,1]
C1274040
UMLS CUI [4,2]
C0011008
Gene Profiling: Screening
Descripción

Gene Profiling: Screening

Alias
UMLS CUI-1
C0752248
UMLS CUI-2
C0220908
Gene list
Descripción

Gene list

Tipo de datos

text

Alias
UMLS CUI [1]
C0017337
Classifier
Descripción

Classifier

Tipo de datos

text

Alias
UMLS CUI [1]
C4291659
Result
Descripción

Result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Index
Descripción

Index

Tipo de datos

integer

Alias
UMLS CUI [1]
C0918012
Laboratory Responsible Signature (Gene Profiling: Screening)
Descripción

Laboratory Responsible Signature (Gene Profiling: Screening)

Alias
UMLS CUI-1
C1550483
UMLS CUI-2
C0022877
UMLS CUI-3
C0752248
UMLS CUI-4
C0220908
Investigator's signature
Descripción

I confirm that I have reviewed the data in this Case Report Form for this Patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature date
Descripción

Investigator's signature date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
MAGE-A3 Expression Test: Recurrence
Descripción

MAGE-A3 Expression Test: Recurrence

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0034897
Was a fresh tumor sample received for MAGE-A3 expression?
Descripción

Was a fresh tumor sample received for MAGE-A3 expression?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2827486
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
Date of reception
Descripción

Date of reception

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0544683
UMLS CUI [1,2]
C0011008
Date of patient’s birth
Descripción

Date of patient’s birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Requisition number
Descripción

Requisition number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0237753
Date of result
Descripción

Date of result

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0011008
Sample not valid
Descripción

Sample not valid

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1519941
Specify other reason for sample not valid
Descripción

Specify other reason for sample not valid

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1519941
UMLS CUI [2]
C3840932
Quantity RNA
Descripción

Quantity RNA

Tipo de datos

float

Unidades de medida
  • ug
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0035668
ug
Quality of RNA
Descripción

Quality of RNA

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0035668
UMLS CUI [1,2]
C0332306
Biopsy amount
Descripción

Biopsy amount

Tipo de datos

integer

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1561574
mg
MAGE-A3 Expression Test: Recurrence - Result
Descripción

MAGE-A3 Expression Test: Recurrence - Result

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0034897
UMLS CUI-5
C1274040
Biopsy - Ct Mage-A3 Result 1
Descripción

Biopsy - Ct Mage-A3 Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0962473
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Mage-A3 Result 2
Descripción

Biopsy - Ct Mage-A3 Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0962473
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Beta Actin Result 1
Descripción

Biopsy - Ct Beta Actin Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0005186
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Biopsy - Ct Beta Actin Result 2
Descripción

Biopsy - Ct Beta Actin Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0005186
UMLS CUI [3]
C5203074
UMLS CUI [4]
C1274040
Positive Control (diluted 100x) - Ct Mage A3 Result 1
Descripción

Positive Control (diluted 100x) - Ct Mage A3 Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0962473
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 100x) - Ct Mage A3 Result 2
Descripción

Positive Control (diluted 100x) - Ct Mage A3 Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0962473
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 1x) - Ct Beta Actin Result 1
Descripción

Positive Control (diluted 1x) - Ct Beta Actin Result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0005186
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
Positive Control (diluted 1x) - Ct Beta Actin Result 2
Descripción

Positive Control (diluted 1x) - Ct Beta Actin Result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C1883676
UMLS CUI [2]
C4281604
UMLS CUI [3]
C0005186
UMLS CUI [4]
C5203074
UMLS CUI [5]
C1274040
MAGE-A3 Expression Test: Recurrence - Result
Descripción

MAGE-A3 Expression Test: Recurrence - Result

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
UMLS CUI-4
C0034897
UMLS CUI-5
C1274040
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Percentage of Positive Control
Descripción

Percentage of Positive Control

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0439165
UMLS CUI [2]
C1883676
%
Mage-A3 Result
Descripción

Mage-A3 Result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0962473
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C1274040
Gene Profiling: Recurrence
Descripción

Gene Profiling: Recurrence

Alias
UMLS CUI-1
C0752248
UMLS CUI-2
C0034897
Requisition number
Descripción

Requisition number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0237753
Has the fresh tumor sample been tested for gene profiling?
Descripción

Has the fresh tumor sample been tested for gene profiling?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
If the fresh tumor sample has not been tested for gene profiling, specify reason
Descripción

If the fresh tumor sample has not been tested for gene profiling, specify reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
UMLS CUI [4]
C0392360
If the fresh tumor sample has not been tested for gene profiling, specify other reason
Descripción

If the fresh tumor sample has not been tested for gene profiling, specify other reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
UMLS CUI [4]
C3840932
If the fresh tumor sample has been tested for gene profiling, record date of result
Descripción

If the fresh tumor sample has been tested for gene profiling, record date of result

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2827486
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
UMLS CUI [3]
C0752248
UMLS CUI [4,1]
C1274040
UMLS CUI [4,2]
C0011008
Gene Profiling: Recurrence
Descripción

Gene Profiling: Recurrence

Alias
UMLS CUI-1
C0752248
UMLS CUI-2
C0034897
Gene list
Descripción

Gene list

Tipo de datos

text

Alias
UMLS CUI [1]
C0017337
Classifier
Descripción

Classifier

Tipo de datos

text

Alias
UMLS CUI [1]
C4291659
Result
Descripción

Result

Tipo de datos

text

Alias
UMLS CUI [1]
C1274040
Index
Descripción

Index

Tipo de datos

integer

Alias
UMLS CUI [1]
C0918012
Laboratory Responsible Signature (Gene Profiling: Recurrence)
Descripción

Laboratory Responsible Signature (Gene Profiling: Recurrence)

Alias
UMLS CUI-1
C1550483
UMLS CUI-2
C0022877
UMLS CUI-3
C0752248
UMLS CUI-4
C0034897
Investigator's signature
Descripción

I confirm that I have reviewed the data in this Case Report Form for this Patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature date
Descripción

Investigator's signature date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Laboratory (Report Final and Annex Report 2 Final)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
MAGE-A3 Expression Test: Screening
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
Was a fresh tumor sample received for MAGE-A3 expression?
Item
Was a fresh tumor sample received for MAGE-A3 expression?
boolean
C0475358 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
Date of reception
Item
Date of reception
date
C0544683 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of patient’s birth
Item
Date of patient’s birth
date
C0421451 (UMLS CUI [1])
Requisition number
Item
Requisition number
text
C0022877 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of result
Item
Date of result
date
C1254595 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Sample not valid
integer
C0370003 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
Sample not valid
Code List
Sample not valid
CL Item
Absence or not enough tissue (1)
CL Item
Not enough RNA for both MAGE-A3 and gene profile testing (2)
CL Item
Invalid negative controls (3)
CL Item
Positive controls out of range (4)
CL Item
B-Actin-MAGE-A3 replicates not acceptable (5)
CL Item
Gerl Ct out of range (6)
CL Item
Gerl replicates not acceptable (7)
CL Item
gDNA MAGE-A3 positive control out of range (8)
CL Item
gDNA contamination (9)
CL Item
Other, specify (10)
Specify other reason for sample not valid
Item
Specify other reason for sample not valid
text
C0370003 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
C3840932 (UMLS CUI [2])
Quantity RNA
Item
Quantity RNA
float
C1265611 (UMLS CUI [1,1])
C0035668 (UMLS CUI [1,2])
Item
Quality of RNA
integer
C0035668 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Quality of RNA
Code List
Quality of RNA
CL Item
Good (1)
CL Item
Intermediate (2)
CL Item
Lost (3)
Biopsy amount
Item
Biopsy amount
integer
C0005558 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Item Group
MAGE-A3 Expression Test: Screening - Result
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
Biopsy - Ct Mage-A3 Result 1
Item
Biopsy - Ct Mage-A3 Result 1
float
C0005558 (UMLS CUI [1])
C0962473 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Mage-A3 Result 2
Item
Biopsy - Ct Mage-A3 Result 2
float
C0005558 (UMLS CUI [1])
C0962473 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Beta Actin Result 1
Item
Biopsy - Ct Beta Actin Result 1
float
C0005558 (UMLS CUI [1])
C0005186 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Beta Actin Result 2
Item
Biopsy - Ct Beta Actin Result 2
float
C0005558 (UMLS CUI [1])
C0005186 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Positive Control (diluted 100x) - Ct Mage A3 Result 1
Item
Positive Control (diluted 100x) - Ct Mage A3 Result 1
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0962473 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 100x) - Ct Mage A3 Result 2
Item
Positive Control (diluted 100x) - Ct Mage A3 Result 2
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0962473 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 1x) - Ct Beta Actin Result 1
Item
Positive Control (diluted 1x) - Ct Beta Actin Result 1
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0005186 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 1x) - Ct Beta Actin Result 2
Item
Positive Control (diluted 1x) - Ct Beta Actin Result 2
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0005186 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Item Group
MAGE-A3 Expression Test: Screening - Result
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Percentage of Positive Control
Item
Percentage of Positive Control
float
C0439165 (UMLS CUI [1])
C1883676 (UMLS CUI [2])
Item
Mage-A3 Result
integer
C0962473 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Mage-A3 Result
Code List
Mage-A3 Result
CL Item
Negative (< 1% Gerl) (1)
CL Item
Positive (> = 1% Gerl) (2)
Item Group
Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening)
C1550483 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
C0962473 (UMLS CUI-3)
C0017262 (UMLS CUI-4)
C0022885 (UMLS CUI-5)
C0220908 (UMLS CUI-6)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
MAGE-A3 Expression Test: Screening (Re-Test)
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
C0205341 (UMLS CUI-5)
Was a fresh tumor sample received for MAGE-A3 expression?
Item
Was a fresh tumor sample received for MAGE-A3 expression?
boolean
C0475358 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
Date of reception
Item
Date of reception
date
C0544683 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Date of patient’s birth
Item
Date of patient’s birth
date
C0421451 (UMLS CUI [1])
Requisition number
Item
Requisition number
text
C0022877 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of result
Item
Date of result
date
C1254595 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Sample not valid
integer
C0370003 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
Sample not valid
Code List
Sample not valid
CL Item
Absence or not enough tissue (1)
CL Item
Not enough RNA for both MAGE-A3 and gene profile testing (2)
CL Item
Invalid negative controls (3)
CL Item
Positive controls out of range (4)
CL Item
B-Actin-MAGE-A3 replicates not acceptable (5)
CL Item
Gerl Ct out of range (6)
CL Item
Gerl replicates not acceptable (7)
CL Item
gDNA MAGE-A3 positive control out of range (8)
CL Item
gDNA contamination (9)
CL Item
Other, specify (10)
Specify other reason for sample not valid
Item
Specify other reason for sample not valid
text
C0370003 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
C3840932 (UMLS CUI [2])
Quantity RNA
Item
Quantity RNA
float
C1265611 (UMLS CUI [1,1])
C0035668 (UMLS CUI [1,2])
Item
Quality of RNA
integer
C0035668 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Quality of RNA
Code List
Quality of RNA
CL Item
Good  (1)
CL Item
Intermediate  (2)
CL Item
Lost (3)
Biopsy amount
Item
Biopsy amount
integer
C0005558 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Item Group
MAGE-A3 Expression Test: Screening (Re-Test) - Result
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
C0205341 (UMLS CUI-5)
C1274040 (UMLS CUI-6)
Biopsy - Ct Mage-A3 Result 1
Item
Biopsy - Ct Mage-A3 Result 1
float
C0005558 (UMLS CUI [1])
C0962473 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Mage-A3 Result 2
Item
Biopsy - Ct Mage-A3 Result 2
float
C0005558 (UMLS CUI [1])
C0962473 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Beta Actin Result 1
Item
Biopsy - Ct Beta Actin Result 1
float
C0005558 (UMLS CUI [1])
C0005186 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Beta Actin Result 2
Item
Biopsy - Ct Beta Actin Result 2
float
C0005558 (UMLS CUI [1])
C0005186 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Positive Control (diluted 100x) - Ct Mage A3 Result 1
Item
Positive Control (diluted 100x) - Ct Mage A3 Result 1
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0962473 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 100x) - Ct Mage A3 Result 2
Item
Positive Control (diluted 100x) - Ct Mage A3 Result 2
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0962473 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 1x) - Ct Beta Actin Result 1
Item
Positive Control (diluted 1x) - Ct Beta Actin Result 1
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0005186 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 1x) - Ct Beta Actin Result 2
Item
Positive Control (diluted 1x) - Ct Beta Actin Result 2
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0005186 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Item Group
MAGE-A3 Expression Test: Screening (Re-Test) - Result
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
C0205341 (UMLS CUI-5)
C1274040 (UMLS CUI-6)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Percentage of Positive Control
Item
Percentage of Positive Control
float
C0439165 (UMLS CUI [1])
C1883676 (UMLS CUI [2])
Item
Mage-A3 Result
integer
C0962473 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Mage-A3 Result
Code List
Mage-A3 Result
CL Item
Negative (< 1% Gerl)  (1)
CL Item
Positive (>=1% Gerl) (2)
Item Group
Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening (Re-Test))
C1550483 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
C0962473 (UMLS CUI-3)
C0017262 (UMLS CUI-4)
C0022885 (UMLS CUI-5)
C0205341 (UMLS CUI-6)
C0220908 (UMLS CUI-7)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Gene Profiling: Screening
C0752248 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Requisition number
Item
Requisition number
text
C0022877 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Has the fresh tumor sample been tested for gene profiling?
Item
Has the fresh tumor sample been tested for gene profiling?
boolean
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
Item
If the fresh tumor sample has not been tested for gene profiling, specify reason
integer
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
C0392360 (UMLS CUI [4])
If the fresh tumor sample has not been tested for gene profiling, specify reason
Code List
If the fresh tumor sample has not been tested for gene profiling, specify reason
CL Item
Absence or not enough tissue (1)
CL Item
Not enough RNA (2)
CL Item
Bad RNA quality (3)
CL Item
QC controls not acceptable (4)
CL Item
Other, specify (5)
If the fresh tumor sample has not been tested for gene profiling, specify other reason
Item
If the fresh tumor sample has not been tested for gene profiling, specify other reason
text
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
C3840932 (UMLS CUI [4])
If the fresh tumor sample has been tested for gene profiling, record date of result
Item
If the fresh tumor sample has been tested for gene profiling, record date of result
date
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
C1274040 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
Item Group
Gene Profiling: Screening
C0752248 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Gene list
Item
Gene list
text
C0017337 (UMLS CUI [1])
Classifier
Item
Classifier
text
C4291659 (UMLS CUI [1])
Item
Result
integer
C1274040 (UMLS CUI [1])
Result
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Index
Item
Index
integer
C0918012 (UMLS CUI [1])
Item Group
Laboratory Responsible Signature (Gene Profiling: Screening)
C1550483 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
C0752248 (UMLS CUI-3)
C0220908 (UMLS CUI-4)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
MAGE-A3 Expression Test: Recurrence
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0034897 (UMLS CUI-4)
Was a fresh tumor sample received for MAGE-A3 expression?
Item
Was a fresh tumor sample received for MAGE-A3 expression?
boolean
C0475358 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
Date of reception
Item
Date of reception
date
C0544683 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of patient’s birth
Item
Date of patient’s birth
date
C0421451 (UMLS CUI [1])
Requisition number
Item
Requisition number
text
C0022877 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of result
Item
Date of result
date
C1254595 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Sample not valid
integer
C0370003 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
Sample not valid
Code List
Sample not valid
CL Item
Absence or not enough tissue (1)
CL Item
Not enough RNA (2)
CL Item
Invalid negative controls (3)
CL Item
Positive controls out of range (4)
CL Item
B-Actin-MAGE-A3 replicates not acceptable (5)
CL Item
Gerl Ct out of range (6)
CL Item
Gerl replicates not acceptable (7)
CL Item
gDNA MAGE-A3 positive control out of range (8)
CL Item
gDNA contamination (9)
CL Item
Other, specify (10)
Specify other reason for sample not valid
Item
Specify other reason for sample not valid
text
C0370003 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
C3840932 (UMLS CUI [2])
Quantity RNA
Item
Quantity RNA
float
C1265611 (UMLS CUI [1,1])
C0035668 (UMLS CUI [1,2])
Item
Quality of RNA
integer
C0035668 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Quality of RNA
Code List
Quality of RNA
CL Item
Good  (1)
CL Item
Intermediate  (2)
CL Item
Lost (3)
Biopsy amount
Item
Biopsy amount
integer
C0005558 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Item Group
MAGE-A3 Expression Test: Recurrence - Result
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0034897 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
Biopsy - Ct Mage-A3 Result 1
Item
Biopsy - Ct Mage-A3 Result 1
float
C0005558 (UMLS CUI [1])
C0962473 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Mage-A3 Result 2
Item
Biopsy - Ct Mage-A3 Result 2
float
C0005558 (UMLS CUI [1])
C0962473 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Beta Actin Result 1
Item
Biopsy - Ct Beta Actin Result 1
float
C0005558 (UMLS CUI [1])
C0005186 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Biopsy - Ct Beta Actin Result 2
Item
Biopsy - Ct Beta Actin Result 2
float
C0005558 (UMLS CUI [1])
C0005186 (UMLS CUI [2])
C5203074 (UMLS CUI [3])
C1274040 (UMLS CUI [4])
Positive Control (diluted 100x) - Ct Mage A3 Result 1
Item
Positive Control (diluted 100x) - Ct Mage A3 Result 1
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0962473 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 100x) - Ct Mage A3 Result 2
Item
Positive Control (diluted 100x) - Ct Mage A3 Result 2
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0962473 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 1x) - Ct Beta Actin Result 1
Item
Positive Control (diluted 1x) - Ct Beta Actin Result 1
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0005186 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Positive Control (diluted 1x) - Ct Beta Actin Result 2
Item
Positive Control (diluted 1x) - Ct Beta Actin Result 2
float
C1883676 (UMLS CUI [1])
C4281604 (UMLS CUI [2])
C0005186 (UMLS CUI [3])
C5203074 (UMLS CUI [4])
C1274040 (UMLS CUI [5])
Item Group
MAGE-A3 Expression Test: Recurrence - Result
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0034897 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Percentage of Positive Control
Item
Percentage of Positive Control
float
C0439165 (UMLS CUI [1])
C1883676 (UMLS CUI [2])
Item
Mage-A3 Result
integer
C0962473 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Mage-A3 Result
Code List
Mage-A3 Result
CL Item
Negative (< 1% Gerl)  (1)
CL Item
Positive (>=1% Gerl) (2)
Item Group
Gene Profiling: Recurrence
C0752248 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
Requisition number
Item
Requisition number
text
C0022877 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Has the fresh tumor sample been tested for gene profiling?
Item
Has the fresh tumor sample been tested for gene profiling?
boolean
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
Item
If the fresh tumor sample has not been tested for gene profiling, specify reason
integer
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
C0392360 (UMLS CUI [4])
If the fresh tumor sample has not been tested for gene profiling, specify reason
Code List
If the fresh tumor sample has not been tested for gene profiling, specify reason
CL Item
Absence or not enough tissue  (1)
CL Item
Not enough RNA  (2)
CL Item
Bad RNA quality  (3)
CL Item
QC controls not acceptable  (4)
CL Item
Other, specify (5)
If the fresh tumor sample has not been tested for gene profiling, specify other reason
Item
If the fresh tumor sample has not been tested for gene profiling, specify other reason
text
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
C3840932 (UMLS CUI [4])
If the fresh tumor sample has been tested for gene profiling, record date of result
Item
If the fresh tumor sample has been tested for gene profiling, record date of result
date
C2827486 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
C0752248 (UMLS CUI [3])
C1274040 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
Item Group
Gene Profiling: Recurrence
C0752248 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
Gene list
Item
Gene list
text
C0017337 (UMLS CUI [1])
Classifier
Item
Classifier
text
C4291659 (UMLS CUI [1])
Item
Result
text
C1274040 (UMLS CUI [1])
Result
Code List
Result
CL Item
Positive  (1)
CL Item
Negative (2)
Index
Item
Index
integer
C0918012 (UMLS CUI [1])
Item Group
Laboratory Responsible Signature (Gene Profiling: Recurrence)
C1550483 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
C0752248 (UMLS CUI-3)
C0034897 (UMLS CUI-4)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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