ID

41513

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. 17-09-20 17-09-20 -
  2. 30-10-20 30-10-20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

30 oktober 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

Best overall response assessment; New tumor biopsy/ sample (Report Final and Annex Report 2 Final)

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient Number

Tipo de datos

text

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

Best overall response assessment

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

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

Tipo de datos

integer

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

If CR, was there a suspicion of residual disease?

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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 ]:
Descripción

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

Tipo de datos

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:
Descripción

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

Tipo de datos

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?
Descripción

Has the patient developed a recurrence / Progressive disease?

Tipo de datos

boolean

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

Recurrence / Progressive disease date

Tipo de datos

date

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

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

Tipo de datos

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:
Descripción

(tick only one box)

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Informed Consent Date

Tipo de datos

date

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

New tumor biopsy/ sample

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

Has a new fresh biopsy been collected?

Tipo de datos

boolean

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

Date of biopsy (fresh biopsy)

Tipo de datos

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)
Descripción

Requisition number (fresh biopsy)

Tipo de datos

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)
Descripción

Tumor biopsy type (fresh biopsy)

Tipo de datos

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)
Descripción

If other tumor biopsy type, specify (fresh biopsy)

Tipo de datos

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)
Descripción

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

Tipo de datos

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?
Descripción

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

Tipo de datos

boolean

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

Date of biopsy (FFPE)

Tipo de datos

date

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

Requisition number (FFPE):

Tipo de datos

text

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

Tumor block or tumor slides? (FFPE)

Tipo de datos

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)
Descripción

Number of tumor slides sent (FFPE)

Tipo de datos

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?
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Other FFPE sample type

Tipo de datos

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)
Descripción

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

Tipo de datos

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)?
Descripción

Yes → Please complete Anti-cancer therapy section

Tipo de datos

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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Similar models

Best overall response assessment; New tumor biopsy/ sample (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)
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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