ID
41489
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)
- 10/27/20 10/27/20 -
- 9/17/21 9/17/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 27, 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
Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)
Description
MAGE-A3 Expression Test
Alias
- UMLS CUI-1
- C0962473
- UMLS CUI-2
- C0017262
- UMLS CUI-3
- C0022885
Description
Has the fresh sample been sent?
Data type
boolean
Alias
- UMLS CUI [1]
- C2827486
Description
If the fresh sample has been sent, record date of sending
Data type
date
Alias
- UMLS CUI [1]
- C2827486
- UMLS CUI [2]
- C0011008
Description
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Data type
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0242356
Description
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Data type
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0421451
Description
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Data type
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3,1]
- C0544683
- UMLS CUI [3,2]
- C0011008
Description
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Data type
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3,1]
- C1274040
- UMLS CUI [3,2]
- C0011008
Description
MAGE-A3 expression test result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C1274040
Description
Tumor Sample (For Re-Test)
Alias
- UMLS CUI-1
- C0475358
Description
Has a new fresh biopsy been collected?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C2827486
Description
Date of biopsy (fresh biopsy):
Data type
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0005558
- UMLS CUI [2,2]
- C2827486
Description
Requisition number (fresh biopsy):
Data type
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0005558
- UMLS CUI [2,2]
- C2827486
Description
Tumor biopsy type (fresh biopsy):
Data type
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
Description
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C2711483
Description
Date of biopsy (FFPE):
Data type
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C2711483
Description
Requisition number (FFPE):
Data type
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C2711483
Description
Tumor block or tumor slides (FFPE)?
Data type
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
Description
Number of tumor slides sent (FFPE)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C0026017
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [2]
- C2711483
Description
Does the FFPE come from the same lesion as the fresh biopsy?
Data type
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
Description
FFPE sample type:
Data type
integer
Alias
- UMLS CUI [1,1]
- C2711483
- UMLS CUI [1,2]
- C0456204
Description
MAGE-A3 Expression Re-Test
Alias
- UMLS CUI-1
- C0962473
- UMLS CUI-2
- C0017262
- UMLS CUI-3
- C0022885
Description
Has the fresh sample been sent?
Data type
boolean
Alias
- UMLS CUI [1]
- C2827486
Description
If the fresh sample has been sent, record date of sending
Data type
date
Alias
- UMLS CUI [1]
- C2827486
- UMLS CUI [2]
- C0011008
Description
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Data type
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0242356
Description
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Data type
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0421451
Description
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Data type
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3,1]
- C0544683
- UMLS CUI [3,2]
- C0011008
Description
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Data type
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3,1]
- C1274040
- UMLS CUI [3,2]
- C0011008
Description
MAGE-A3 expression test result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C1274040
Description
Prior Surgery
Alias
- UMLS CUI-1
- C0744961
Description
Prior Surgery Type
Alias
- UMLS CUI-1
- C0744961
- UMLS CUI-2
- C0332307
Description
Prior Surgery Type
Data type
integer
Alias
- UMLS CUI [1,1]
- C0744961
- UMLS CUI [1,2]
- C0332307
Description
Date of last surgery
Data type
date
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
Description
Prior Surgery
Alias
- UMLS CUI-1
- C0744961
Description
Prior Therapy
Alias
- UMLS CUI-1
- C1514463
Description
1) Prior adjuvant treatment with Interferon?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1522673
- UMLS CUI [2]
- C0021747
Description
Date of last dose (Interferon):
Data type
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0021747
Description
Did the patient receive more than one treatment line?
Data type
boolean
Alias
- UMLS CUI [1]
- C1522541
Description
2) Prior treatment with cancer vaccine?
Data type
boolean
Alias
- UMLS CUI [1]
- C1514463
- UMLS CUI [2,1]
- C0920425
- UMLS CUI [2,2]
- C0042210
Description
Date of last dose (cancer vaccine):
Data type
date
Alias
- UMLS CUI [1]
- C1762893
- UMLS CUI [2,1]
- C0920425
- UMLS CUI [2,2]
- C0042210
Description
3) Prior treatment with anti-CTL-A4 based therapy?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C4289973
Description
Date of last dose (anti-CTL-A4):
Data type
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C4289973
Description
4) Prior treatment with radiotherapy?
Data type
boolean
Alias
- UMLS CUI [1]
- C0279134
Description
Date of last dose (radiotherapy):
Data type
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0279134
Description
5) Prior isolated limb perfusion?
Data type
boolean
Alias
- UMLS CUI [1]
- C0396670
Description
Date of last dose (isolated limb perfusion):
Data type
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0396670
Description
6) Prior treatment with systemic chemotherapy?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C1883256
Description
Date of last dose (systemic chemotherapy):
Data type
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C1883256
Description
7) Prior treatment with systemic immunosuppressants within 6 months?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0021079
- UMLS CUI [1,3]
- C0205373
Description
Prior treatment with systemic immunosuppressants
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0021079
- UMLS CUI-3
- C0205373
Description
Trade/ Generic Name
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Description
Other immunosuppressant
Data type
text
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205394
Description
Max. daily dose
Data type
float
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0806909
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Immunosuppressant start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0808070
Description
Immunosuppressant stop date
Data type
date
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0806020
Description
Immunosuppressant ongoing?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0549178
Similar models
Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0011008 (UMLS CUI [2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0242356 (UMLS CUI [3])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0421451 (UMLS CUI [3])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0544683 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
C2827486 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C2711483 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C1265611 (UMLS CUI [1,2])
C2317347 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0026017 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
C0026017 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2711483 (UMLS CUI [2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
C0456204 (UMLS CUI [1,2])
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0011008 (UMLS CUI [2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0242356 (UMLS CUI [3])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0421451 (UMLS CUI [3])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0544683 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C2826210 (UMLS CUI [1,2])
C1522673 (UMLS CUI [1,2])
C0021747 (UMLS CUI [2])
C0021747 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0920425 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C4289973 (UMLS CUI [1,2])
C4289973 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,2])
C0396670 (UMLS CUI [1,2])
C1883256 (UMLS CUI [1,2])
C1883256 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0021079 (UMLS CUI-2)
C0205373 (UMLS CUI-3)
C2360065 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])