ID
42772
Beschrijving
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
Trefwoorden
Versies (2)
- 20-08-20 20-08-20 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
MAGE-A3 Expression Test
Alias
- UMLS CUI-1
- C0962473
- UMLS CUI-2
- C0017262
- UMLS CUI-3
- C0022885
Beschrijving
Has the fresh sample been sent?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2827486
Beschrijving
If the fresh sample has been sent, record date of sending
Datatype
date
Alias
- UMLS CUI [1]
- C2827486
- UMLS CUI [2]
- C0011008
Beschrijving
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0242356
Beschrijving
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Datatype
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0421451
Beschrijving
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Datatype
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
Beschrijving
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Datatype
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
Beschrijving
MAGE-A3 expression test result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C1274040
Beschrijving
Tumor Sample (For Re-Test)
Alias
- UMLS CUI-1
- C0475358
Beschrijving
Has a new fresh biopsy been collected?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C2827486
Beschrijving
Date of biopsy (fresh biopsy):
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0005558
- UMLS CUI [2,2]
- C2827486
Beschrijving
Requisition number (fresh biopsy):
Datatype
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0005558
- UMLS CUI [2,2]
- C2827486
Beschrijving
Tumor biopsy type (fresh biopsy):
Datatype
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
Beschrijving
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C2711483
Beschrijving
Date of biopsy (FFPE):
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C2711483
Beschrijving
Requisition number (FFPE):
Datatype
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C2711483
Beschrijving
Tumor block or tumor slides (FFPE)?
Datatype
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]
- C1705201
- UMLS CUI [3]
- C2711483
Beschrijving
Number of tumor slides sent (FFPE)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C1705201
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [2]
- C2711483
Beschrijving
Does the FFPE come from the same lesion as the fresh biopsy?
Datatype
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
Beschrijving
FFPE sample type:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2711483
- UMLS CUI [1,2]
- C0456204
Beschrijving
MAGE-A3 Expression Re-Test
Alias
- UMLS CUI-1
- C0962473
- UMLS CUI-2
- C0017262
- UMLS CUI-3
- C0022885
Beschrijving
Has the fresh sample been sent?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2827486
Beschrijving
If the fresh sample has been sent, record date of sending
Datatype
date
Alias
- UMLS CUI [1]
- C2827486
- UMLS CUI [2]
- C0011008
Beschrijving
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0242356
Beschrijving
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Datatype
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0421451
Beschrijving
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Datatype
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
Beschrijving
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Datatype
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
Beschrijving
MAGE-A3 expression test result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C1274040
Beschrijving
Prior Surgery
Alias
- UMLS CUI-1
- C0744961
Beschrijving
Prior Surgery Type
Alias
- UMLS CUI-1
- C0744961
- UMLS CUI-2
- C0332307
Beschrijving
Prior Surgery Type
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0744961
- UMLS CUI [1,2]
- C0332307
Beschrijving
Date of last surgery
Datatype
date
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
Beschrijving
Prior Therapy
Alias
- UMLS CUI-1
- C1514463
Beschrijving
1) Prior adjuvant treatment with Interferon?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1522673
- UMLS CUI [2]
- C0021747
Beschrijving
Date of last dose (Interferon):
Datatype
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0021747
Beschrijving
Did the patient receive more than one treatment line?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1522541
Beschrijving
2) Prior treatment with cancer vaccine?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1514463
- UMLS CUI [2,1]
- C0920425
- UMLS CUI [2,2]
- C0042210
Beschrijving
Date of last dose (cancer vaccine):
Datatype
date
Alias
- UMLS CUI [1]
- C1762893
- UMLS CUI [2,1]
- C0920425
- UMLS CUI [2,2]
- C0042210
Beschrijving
3) Prior treatment with anti-CTL-A4 based therapy?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C4289973
Beschrijving
Date of last dose (anti-CTL-A4):
Datatype
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C4289973
Beschrijving
4) Prior treatment with radiotherapy?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0279134
Beschrijving
Date of last dose (radiotherapy):
Datatype
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0279134
Beschrijving
5) Prior isolated limb perfusion?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0396670
Beschrijving
Date of last dose (isolated limb perfusion):
Datatype
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0396670
Beschrijving
6) Prior treatment with systemic chemotherapy?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C1883256
Beschrijving
Date of last dose (systemic chemotherapy):
Datatype
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C1883256
Beschrijving
7) Prior treatment with systemic immunosuppressants within 6 months?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0021079
- UMLS CUI [1,3]
- C0205373
Beschrijving
Prior treatment with systemic immunosuppressants
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0021079
- UMLS CUI-3
- C0205373
Beschrijving
Trade/ Generic Name
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Beschrijving
Other immunosuppressant
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205394
Beschrijving
Max. daily dose
Datatype
float
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0806909
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Immunosuppressant start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0808070
Beschrijving
Immunosuppressant stop date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0806020
Beschrijving
Immunosuppressant ongoing?
Datatype
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
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])
C1705201 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
C1705201 (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])
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])