ID
41489
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)
- 27.10.20 27.10.20 -
- 17.09.21 17.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. Oktober 2020
DOI
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Lizenz
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)
Beschreibung
MAGE-A3 Expression Test
Alias
- UMLS CUI-1
- C0962473
- UMLS CUI-2
- C0017262
- UMLS CUI-3
- C0022885
Beschreibung
Has the fresh sample been sent?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2827486
Beschreibung
If the fresh sample has been sent, record date of sending
Datentyp
date
Alias
- UMLS CUI [1]
- C2827486
- UMLS CUI [2]
- C0011008
Beschreibung
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0242356
Beschreibung
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0421451
Beschreibung
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Datentyp
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
Beschreibung
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Datentyp
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
Beschreibung
MAGE-A3 expression test result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C1274040
Beschreibung
Tumor Sample (For Re-Test)
Alias
- UMLS CUI-1
- C0475358
Beschreibung
Has a new fresh biopsy been collected?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C2827486
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
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
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
Beschreibung
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C2711483
Beschreibung
Date of biopsy (FFPE):
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C2711483
Beschreibung
Requisition number (FFPE):
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C2711483
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
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
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
Beschreibung
FFPE sample type:
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2711483
- UMLS CUI [1,2]
- C0456204
Beschreibung
MAGE-A3 Expression Re-Test
Alias
- UMLS CUI-1
- C0962473
- UMLS CUI-2
- C0017262
- UMLS CUI-3
- C0022885
Beschreibung
Has the fresh sample been sent?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2827486
Beschreibung
If the fresh sample has been sent, record date of sending
Datentyp
date
Alias
- UMLS CUI [1]
- C2827486
- UMLS CUI [2]
- C0011008
Beschreibung
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0242356
Beschreibung
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0475358
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [3]
- C0421451
Beschreibung
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Datentyp
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
Beschreibung
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Datentyp
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
Beschreibung
MAGE-A3 expression test result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C1274040
Beschreibung
Prior Surgery
Alias
- UMLS CUI-1
- C0744961
Beschreibung
Prior Surgery Type
Alias
- UMLS CUI-1
- C0744961
- UMLS CUI-2
- C0332307
Beschreibung
Prior Surgery Type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0744961
- UMLS CUI [1,2]
- C0332307
Beschreibung
Date of last surgery
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
Beschreibung
Prior Surgery
Alias
- UMLS CUI-1
- C0744961
Beschreibung
Prior Therapy
Alias
- UMLS CUI-1
- C1514463
Beschreibung
1) Prior adjuvant treatment with Interferon?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1522673
- UMLS CUI [2]
- C0021747
Beschreibung
Date of last dose (Interferon):
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0021747
Beschreibung
Did the patient receive more than one treatment line?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1522541
Beschreibung
2) Prior treatment with cancer vaccine?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1514463
- UMLS CUI [2,1]
- C0920425
- UMLS CUI [2,2]
- C0042210
Beschreibung
Date of last dose (cancer vaccine):
Datentyp
date
Alias
- UMLS CUI [1]
- C1762893
- UMLS CUI [2,1]
- C0920425
- UMLS CUI [2,2]
- C0042210
Beschreibung
3) Prior treatment with anti-CTL-A4 based therapy?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C4289973
Beschreibung
Date of last dose (anti-CTL-A4):
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C4289973
Beschreibung
4) Prior treatment with radiotherapy?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0279134
Beschreibung
Date of last dose (radiotherapy):
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0279134
Beschreibung
5) Prior isolated limb perfusion?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0396670
Beschreibung
Date of last dose (isolated limb perfusion):
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C0396670
Beschreibung
6) Prior treatment with systemic chemotherapy?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C1883256
Beschreibung
Date of last dose (systemic chemotherapy):
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C1883256
Beschreibung
7) Prior treatment with systemic immunosuppressants within 6 months?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0021079
- UMLS CUI [1,3]
- C0205373
Beschreibung
Prior treatment with systemic immunosuppressants
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0021079
- UMLS CUI-3
- C0205373
Beschreibung
Trade/ Generic Name
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Beschreibung
Other immunosuppressant
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205394
Beschreibung
Max. daily dose
Datentyp
float
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0806909
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Immunosuppressant start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0808070
Beschreibung
Immunosuppressant stop date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0806020
Beschreibung
Immunosuppressant ongoing?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0549178
Ähnliche Modelle
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])