ID

41532

Description

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

Keywords

Versions (2)
  1. 10/26/20 10/26/20 -
  2. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 2, 2020

DOI

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License

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

English

Laboratory (Report Final and Annex Report 2 Final)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Centre number
Description

Centre number

Data type

text

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

Patient Number

Data type

text

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

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?
Description

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

Data type

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
Description

Date of reception

Data type

date

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

Date of patient’s birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Requisition number
Description

Requisition number

Data type

text

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

Date of result

Data type

date

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

Sample not valid

Data type

integer

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

Specify other reason for sample not valid

Data type

text

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

Quantity RNA

Data type

float

Measurement units
  • ug
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0035668
ug
Quality of RNA
Description

Quality of RNA

Data type

integer

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

Biopsy amount

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1561574
mg
MAGE-A3 Expression Test: Screening - Result
Description

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
Description

Biopsy - Ct Mage-A3 Result 1

Data type

float

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

Biopsy - Ct Mage-A3 Result 2

Data type

float

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

Biopsy - Ct Beta Actin Result 1

Data type

float

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

Biopsy - Ct Beta Actin Result 2

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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
Description

Comments

Data type

text

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

Percentage of Positive Control

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0439165
UMLS CUI [2]
C1883676
%
Mage-A3 Result
Description

Mage-A3 Result

Data type

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)
Description

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
Description

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.

Data type

text

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

Printed Investigator's name

Data type

text

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

Investigator's signature date

Data type

date

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

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?
Description

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

Data type

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
Description

Date of reception

Data type

date

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

Date of patient’s birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Requisition number
Description

Requisition number

Data type

text

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

Date of result

Data type

date

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

Sample not valid

Data type

integer

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

Specify other reason for sample not valid

Data type

text

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

Quantity RNA

Data type

float

Measurement units
  • ug
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0035668
ug
Quality of RNA
Description

Quality of RNA

Data type

integer

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

Biopsy amount

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1561574
mg
MAGE-A3 Expression Test: Screening (Re-Test) - Result
Description

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
Description

Biopsy - Ct Mage-A3 Result 1

Data type

float

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

Biopsy - Ct Mage-A3 Result 2

Data type

float

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

Biopsy - Ct Beta Actin Result 1

Data type

float

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

Biopsy - Ct Beta Actin Result 2

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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
Description

Comments

Data type

text

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

Percentage of Positive Control

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0439165
UMLS CUI [2]
C1883676
%
Mage-A3 Result
Description

Mage-A3 Result

Data type

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))
Description

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
Description

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.

Data type

text

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

Printed Investigator's name

Data type

text

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

Investigator's signature date

Data type

date

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

Gene Profiling: Screening

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

Requisition number

Data type

text

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

Has the fresh tumor sample been tested for gene profiling?

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Gene Profiling: Screening

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

Gene list

Data type

text

Alias
UMLS CUI [1]
C0017337
Classifier
Description

Classifier

Data type

text

Alias
UMLS CUI [1]
C4291659
Result
Description

Result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Index
Description

Index

Data type

integer

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

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
Description

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.

Data type

text

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

Printed Investigator's name

Data type

text

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

Investigator's signature date

Data type

date

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

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?
Description

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

Data type

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
Description

Date of reception

Data type

date

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

Date of patient’s birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Requisition number
Description

Requisition number

Data type

text

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

Date of result

Data type

date

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

Sample not valid

Data type

integer

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

Specify other reason for sample not valid

Data type

text

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

Quantity RNA

Data type

float

Measurement units
  • ug
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0035668
ug
Quality of RNA
Description

Quality of RNA

Data type

integer

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

Biopsy amount

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1561574
mg
MAGE-A3 Expression Test: Recurrence - Result
Description

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
Description

Biopsy - Ct Mage-A3 Result 1

Data type

float

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

Biopsy - Ct Mage-A3 Result 2

Data type

float

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

Biopsy - Ct Beta Actin Result 1

Data type

float

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

Biopsy - Ct Beta Actin Result 2

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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
Description

Comments

Data type

text

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

Percentage of Positive Control

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0439165
UMLS CUI [2]
C1883676
%
Mage-A3 Result
Description

Mage-A3 Result

Data type

integer

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

Gene Profiling: Recurrence

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

Requisition number

Data type

text

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

Has the fresh tumor sample been tested for gene profiling?

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Gene Profiling: Recurrence

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

Gene list

Data type

text

Alias
UMLS CUI [1]
C0017337
Classifier
Description

Classifier

Data type

text

Alias
UMLS CUI [1]
C4291659
Result
Description

Result

Data type

text

Alias
UMLS CUI [1]
C1274040
Index
Description

Index

Data type

integer

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

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
Description

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.

Data type

text

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

Printed Investigator's name

Data type

text

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

Investigator's signature date

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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