ID

41379

Beschreibung

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

Stichworte

Versionen (2)
  1. 17.09.20 17.09.20 -
  2. 30.10.20 30.10.20 -
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GlaxoSmithKline

Hochgeladen am

17. September 2020

DOI

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

Englisch

Best overall response assessment; New tumor biopsy/ sample

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Best overall response assessment
Beschreibung

Best overall response assessment

Alias
UMLS CUI-1
C2986560
UMLS CUI-2
C1516048
What is the best overall response assessed during the study?
Beschreibung

* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable

Datentyp

integer

Alias
UMLS CUI [1,1]
C2986560
UMLS CUI [1,2]
C1516048
If CR, was there a suspicion of residual disease?
Beschreibung

If CR, was there a suspicion of residual disease?

Datentyp

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C0543478
If suspicion of residual disease, was CR status been confirmed by cytology?
Beschreibung

If suspicion of residual disease, was CR status been confirmed by cytology?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543478
UMLS CUI [1,2]
C0242114
UMLS CUI [2]
C0677874
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C0010819
Date of first documented [ CR ], [ PR ] response
Beschreibung

Date of first documented [ CR ], [ PR ] response

Datentyp

date

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3,1]
C0011008
UMLS CUI [3,2]
C0920316
UMLS CUI [3,3]
C0205435
Date of best response confirmation [ CR ], [ PR ]:
Beschreibung

Date of best response confirmation [ CR ], [ PR ]:

Datentyp

date

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2,1]
C2986560
UMLS CUI [2,2]
C0750484
UMLS CUI [3]
C0677874
UMLS CUI [4]
C1521726
If [ SD ], [SD/PR*]: Date of last documented stable disease:
Beschreibung

If [ SD ], [SD/PR*]: Date of last documented stable disease:

Datentyp

date

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2]
C1521726
UMLS CUI [3,1]
C1517741
UMLS CUI [3,2]
C1301725
UMLS CUI [3,3]
C0011008
Has the patient developed a recurrence / Progressive disease?
Beschreibung

Has the patient developed a recurrence / Progressive disease?

Datentyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0277556
Recurrence / Progressive disease date
Beschreibung

Recurrence / Progressive disease date

Datentyp

date

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0011008
Has the recurrence / progressive disease been histologically or cytologically confirmed?
Beschreibung

Has the recurrence / progressive disease been histologically or cytologically confirmed?

Datentyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0679254
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C0205462
UMLS CUI [4,1]
C0750484
UMLS CUI [4,2]
C0205471
Please specify the method used to confirm the recurrence / progressive disease:
Beschreibung

(tick only one box)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0750484
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0750484
UMLS CUI [3,1]
C2348235
UMLS CUI [3,2]
C0871511
Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
Beschreibung

Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression

Datentyp

text

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [2,3]
C0022885
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C0205314
UMLS CUI [3,3]
C0027651
UMLS CUI [4]
C0242656
Informed Consent Date
Beschreibung

Informed Consent Date

Datentyp

date

Alias
UMLS CUI [1]
C2985782
New tumor biopsy/ sample
Beschreibung

New tumor biopsy/ sample

Alias
UMLS CUI-1
C0475358
UMLS CUI-2
C0005558
UMLS CUI-3
C0205314
Has a new fresh biopsy been collected?
Beschreibung

Has a new fresh biopsy been collected?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C2827486
UMLS CUI [1,3]
C1516698
Date of biopsy (fresh biopsy)
Beschreibung

Date of biopsy (fresh biopsy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2827486
Requisition number (fresh biopsy)
Beschreibung

Requisition number (fresh biopsy)

Datentyp

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2827486
Tumor biopsy type (fresh biopsy)
Beschreibung

Tumor biopsy type (fresh biopsy)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0332307
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2827486
If other tumor biopsy type, specify (fresh biopsy)
Beschreibung

If other tumor biopsy type, specify (fresh biopsy)

Datentyp

text

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0332307
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
UMLS CUI [4,1]
C0005558
UMLS CUI [4,2]
C2827486
What is the status of the lesion resected? (fresh biopsy)
Beschreibung

What is the status of the lesion resected? (fresh biopsy)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C0449438
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C2827486
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Beschreibung

Has a new Formalin fixed Paraffin embedded (FFPE) been collected?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2711483
UMLS CUI [2]
C1516698
UMLS CUI [3]
C0205314
Date of biopsy (FFPE)
Beschreibung

Date of biopsy (FFPE)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C2711483
Requisition number (FFPE):
Beschreibung

Requisition number (FFPE):

Datentyp

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C2711483
Tumor block or tumor slides? (FFPE)
Beschreibung

Tumor block or tumor slides? (FFPE)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2317347
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0026017
UMLS CUI [3]
C2711483
Number of tumor slides sent (FFPE)
Beschreibung

Number of tumor slides sent (FFPE)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0026017
UMLS CUI [1,3]
C0237753
UMLS CUI [2]
C2711483
Does the FFPE come from the same lesion as the fresh biopsy?
Beschreibung

Does the FFPE come from the same lesion as the fresh biopsy?

Datentyp

boolean

Alias
UMLS CUI [1]
C2711483
UMLS CUI [2,1]
C0677862
UMLS CUI [2,2]
C2827486
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0445247
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
Beschreibung

If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type

Datentyp

integer

Alias
UMLS CUI [1]
C2711483
UMLS CUI [2,1]
C0677862
UMLS CUI [2,2]
C2827486
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0445247
UMLS CUI [4]
C2347029
Other FFPE sample type
Beschreibung

Other FFPE sample type

Datentyp

text

Alias
UMLS CUI [1]
C2711483
UMLS CUI [2]
C2347029
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
What is the status of the lesion resected? (FFPE)
Beschreibung

What is the status of the lesion resected? (FFPE)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C0449438
UMLS CUI [3]
C2711483
Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
Beschreibung

Yes → Please complete Anti-cancer therapy section

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C0949266
UMLS CUI [3,2]
C0205394
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Ähnliche Modelle

Best overall response assessment; New tumor biopsy/ sample

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Best overall response assessment
C2986560 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Item
What is the best overall response assessed during the study?
integer
C2986560 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
What is the best overall response assessed during the study?
Code List
What is the best overall response assessed during the study?
CL Item
CR (1)
CL Item
PR (2)
CL Item
SD (3)
CL Item
SD / PR (4)
CL Item
PD (5)
CL Item
NE** (6)
If CR, was there a suspicion of residual disease?
Item
If CR, was there a suspicion of residual disease?
boolean
C0677874 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
If suspicion of residual disease, was CR status been confirmed by cytology?
Item
If suspicion of residual disease, was CR status been confirmed by cytology?
boolean
C0543478 (UMLS CUI [1,1])
C0242114 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2])
C0750484 (UMLS CUI [3,1])
C0010819 (UMLS CUI [3,2])
Date of first documented [ CR ], [ PR ] response
Item
Date of first documented [ CR ], [ PR ] response
date
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C0011008 (UMLS CUI [3,1])
C0920316 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
Date of best response confirmation [ CR ], [ PR ]:
Item
Date of best response confirmation [ CR ], [ PR ]:
date
C0011008 (UMLS CUI [1])
C2986560 (UMLS CUI [2,1])
C0750484 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3])
C1521726 (UMLS CUI [4])
If [ SD ], [SD/PR*]: Date of last documented stable disease:
Item
If [ SD ], [SD/PR*]: Date of last documented stable disease:
date
C0677946 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C1517741 (UMLS CUI [3,1])
C1301725 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Has the patient developed a recurrence / Progressive disease?
Item
Has the patient developed a recurrence / Progressive disease?
boolean
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Recurrence / Progressive disease date
Item
Recurrence / Progressive disease date
date
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
Has the recurrence / progressive disease been histologically or cytologically confirmed?
Item
Has the recurrence / progressive disease been histologically or cytologically confirmed?
boolean
C1335499 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0750484 (UMLS CUI [3,1])
C0205462 (UMLS CUI [3,2])
C0750484 (UMLS CUI [4,1])
C0205471 (UMLS CUI [4,2])
Item
Please specify the method used to confirm the recurrence / progressive disease:
integer
C0277556 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0750484 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3,1])
C0871511 (UMLS CUI [3,2])
Please specify the method used to confirm the recurrence / progressive disease:
Code List
Please specify the method used to confirm the recurrence / progressive disease:
CL Item
Cytology  (1)
CL Item
Histology → Please complete ICF section for MAGE-A3 Expression testing and for gene profiling of newly resected tumors in case of disease progression.  (2)
CL Item
Cytology and histology → Please complete ICF section for MAGE-A3 Expression testing and for gene profiling of newly resected tumors in case of disease progression. (3)
Item
Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
text
C0021430 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
Code List
Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
CL Item
Yes (Y)
CL Item
No (N)
CL Item
NA (NA)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
New tumor biopsy/ sample
C0475358 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
C0205314 (UMLS CUI-3)
Has a new fresh biopsy been collected?
Item
Has a new fresh biopsy been collected?
boolean
C0005558 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
Date of biopsy (fresh biopsy)
Item
Date of biopsy (fresh biopsy)
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Requisition number (fresh biopsy)
Item
Requisition number (fresh biopsy)
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Item
Tumor biopsy type (fresh biopsy)
integer
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Tumor biopsy type:
Code List
Tumor biopsy type (fresh biopsy)
CL Item
Skin (1)
CL Item
Subcutaneous (2)
CL Item
Lymphnode (3)
CL Item
Other, specify (4)
If other tumor biopsy type, specify (fresh biopsy)
Item
If other tumor biopsy type, specify (fresh biopsy)
text
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0005558 (UMLS CUI [4,1])
C2827486 (UMLS CUI [4,2])
Item
What is the status of the lesion resected? (fresh biopsy)
integer
C0728940 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C2827486 (UMLS CUI [3,2])
What is the status of the lesion resected?
Code List
What is the status of the lesion resected? (fresh biopsy)
CL Item
New lesion (1)
CL Item
Progressive target lesion (2)
CL Item
Progressive non-target lesion (3)
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Item
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C1516698 (UMLS CUI [2])
C0205314 (UMLS CUI [3])
Date of biopsy (FFPE)
Item
Date of biopsy (FFPE)
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Requisition number (FFPE):
Item
Requisition number (FFPE):
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Item
Tumor block or tumor slides? (FFPE)
integer
C0475358 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2317347 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0026017 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
Tumor block or tumor slides? (FFPE)
Code List
Tumor block or tumor slides? (FFPE)
CL Item
Tumor block  (1)
CL Item
Tumor slides (2)
Number of tumor slides sent (FFPE)
Item
Number of tumor slides sent (FFPE)
integer
C0027651 (UMLS CUI [1,1])
C0026017 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2711483 (UMLS CUI [2])
Does the FFPE come from the same lesion as the fresh biopsy?
Item
Does the FFPE come from the same lesion as the fresh biopsy?
boolean
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
Item
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
integer
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
C2347029 (UMLS CUI [4])
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
Code List
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
CL Item
Skin  (1)
CL Item
Subcutaneous  (2)
CL Item
Lymphnode (3)
CL Item
Other, please specify (4)
Other FFPE sample type
Item
Other FFPE sample type
text
C2711483 (UMLS CUI [1])
C2347029 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
What is the status of the lesion resected? (FFPE)
integer
C0728940 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
C2711483 (UMLS CUI [3])
What is the status of the lesion resected? (FFPE)
Code List
What is the status of the lesion resected? (FFPE)
CL Item
New lesion  (1)
CL Item
Progressive target lesion  (2)
CL Item
Progressive non-target lesion (3)
Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
Item
Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
boolean
C0920425 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
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