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ID

41542

Descrizione

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

versioni (2)
  1. 24/10/20 24/10/20 -
  2. 03/11/20 03/11/20 -
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GlaxoSmithKline

Caricato su

3 novembre 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

    Inglese

    Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature (Report Final and Annex Report 2 Final)

    1 moduli  
    Administrative
    Descrizione

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Centre
    Descrizione

    Centre

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Laboratory Reference Ranges
    Descrizione

    Laboratory Reference Ranges

    Alias
    UMLS CUI-1
    C0883335
    Laboratory Name
    Descrizione

    Laboratory Name

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C3258037
    Lab Code
    Descrizione

    Lab Code

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0805701
    Date these reference ranges became effective
    Descrizione

    Date these reference ranges became effective

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0883335
    UMLS CUI [1,2]
    C0011008
    Age range low
    Descrizione

    Age range low

    Tipo di dati

    float

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1514721
    UMLS CUI [1,3]
    C0205251
    Age range high
    Descrizione

    Age range high

    Tipo di dati

    float

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1514721
    UMLS CUI [1,3]
    C0205250
    Age units
    Descrizione

    Age units

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1519795
    Sex
    Descrizione

    Sex

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0079399
    Laboratory Reference Ranges - Haematology
    Descrizione

    Laboratory Reference Ranges - Haematology

    Alias
    UMLS CUI-1
    C0883335
    UMLS CUI-2
    C0018941
    Haematology - Test
    Descrizione

    Haematology - Test

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Haematology - Unit
    Descrizione

    Haematology - Unit

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1519795
    Haematology - Low Reference Value
    Descrizione

    Haematology - Low Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0018941
    UMLS CUI [2]
    C1272773
    Haematology - High Reference Value
    Descrizione

    Haematology - High Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0018941
    UMLS CUI [2]
    C1299400
    Laboratory Reference Ranges - Biochemistry
    Descrizione

    Laboratory Reference Ranges - Biochemistry

    Alias
    UMLS CUI-1
    C0883335
    UMLS CUI-2
    C0005477
    Biochemistry - Test
    Descrizione

    Biochemistry - Test

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1655775
    Biochemistry - Unit
    Descrizione

    Biochemistry - Unit

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0005477
    UMLS CUI [2]
    C1519795
    Biochemistry - Low Reference Value
    Descrizione

    Biochemistry - Low Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0005477
    UMLS CUI [2]
    C1272773
    Biochemistry - High Reference Value
    Descrizione

    Biochemistry - High Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0005477
    UMLS CUI [2]
    C1299400
    Laboratory Reference Ranges - Hepatic Function
    Descrizione

    Laboratory Reference Ranges - Hepatic Function

    Alias
    UMLS CUI-1
    C0883335
    UMLS CUI-2
    C0232741
    Hepatic function - Test
    Descrizione

    Hepatic function - Test

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0022885
    Hepatic function - Unit
    Descrizione

    Hepatic function - Unit

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1519795
    Hepatic function - Low Reference Value
    Descrizione

    Hepatic function - Low Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1272773
    Hepatic function - High Reference Value
    Descrizione

    Hepatic function - High Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1299400
    Laboratory Reference Ranges - Renal Function
    Descrizione

    Laboratory Reference Ranges - Renal Function

    Alias
    UMLS CUI-1
    C0883335
    UMLS CUI-2
    C0232804
    Renal function - Test
    Descrizione

    Renal function - Test

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0022885
    Renal function - Unit
    Descrizione

    Renal function - Unit

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C1519795
    Renal function - Low Reference Value
    Descrizione

    Renal function - Low Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C1272773
    Renal function - High Reference Value
    Descrizione

    Renal function - High Reference Value

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C1299400
    Use of human samples by GSK
    Descrizione

    Use of human samples by GSK

    Alias
    UMLS CUI-1
    C2347026
    UMLS CUI-2
    C0086418
    UMLS CUI-3
    C0457083
    Use of human samples by GSK
    Descrizione

    Use of human samples by GSK

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2347026
    UMLS CUI [1,2]
    C0086418
    UMLS CUI [1,3]
    C0457083
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    Descrizione

    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1698986
    UMLS CUI [2]
    C0449238
    UMLS CUI [3]
    C0021430
    Specify other storage period
    Descrizione

    Specify other storage period

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1698986
    UMLS CUI [2]
    C0449238
    UMLS CUI [3]
    C0205394
    ICF Effective date
    Descrizione

    Complete and submit a new form for each change during the study.

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0009797
    Investigator's Signature
    Descrizione

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's Signature
    Descrizione

    Investigator's Signature

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2346576
    Printed Investigator's name
    Descrizione

    Printed Investigator's name

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator's signature date
    Descrizione

    Investigator's signature date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Ritorna all'inizio della pagina

    Similar models

    Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature (Report Final and Annex Report 2 Final)

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Centre
    Item
    Centre
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Laboratory Reference Ranges
    C0883335 (UMLS CUI-1)
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Lab Code
    Item
    Lab Code
    text
    C0022885 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Date these reference ranges became effective
    Item
    Date these reference ranges became effective
    date
    C0883335 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Age range low
    Item
    Age range low
    float
    C0001779 (UMLS CUI [1,1])
    C1514721 (UMLS CUI [1,2])
    C0205251 (UMLS CUI [1,3])
    Age range high
    Item
    Age range high
    float
    C0001779 (UMLS CUI [1,1])
    C1514721 (UMLS CUI [1,2])
    C0205250 (UMLS CUI [1,3])
    Item
    Age units
    integer
    C0001779 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Age units
    Code List
    Age units
    CL Item
    Years (1)
    CL Item
    Month (2)
    CL Item
    Weeks (3)
    CL Item
    Days (4)
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Male reference range (M)
    CL Item
    Female reference range (F)
    CL Item
    Male and Female reference range (B)
    Item Group
    Laboratory Reference Ranges - Haematology
    C0883335 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    Item
    Haematology - Test
    integer
    C0018941 (UMLS CUI [1])
    Haematology - Test
    Code List
    Haematology - Test
    CL Item
    Hemoglobin (1)
    CL Item
    Platelets (2)
    CL Item
    White Blood Cells (3)
    CL Item
    Neutrophils (4)
    CL Item
    Lymphocytes (5)
    Haematology - Unit
    Item
    Haematology - Unit
    text
    C0018941 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Haematology - Low Reference Value
    Item
    Haematology - Low Reference Value
    float
    C0018941 (UMLS CUI [1])
    C1272773 (UMLS CUI [2])
    Haematology - High Reference Value
    Item
    Haematology - High Reference Value
    float
    C0018941 (UMLS CUI [1])
    C1299400 (UMLS CUI [2])
    Item Group
    Laboratory Reference Ranges - Biochemistry
    C0883335 (UMLS CUI-1)
    C0005477 (UMLS CUI-2)
    Item
    Biochemistry - Test
    integer
    C1655775 (UMLS CUI [1])
    Biochemistry - Test
    Code List
    Biochemistry - Test
    CL Item
    LDH (1)
    Biochemistry - Unit
    Item
    Biochemistry - Unit
    text
    C0005477 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Biochemistry - Low Reference Value
    Item
    Biochemistry - Low Reference Value
    float
    C0005477 (UMLS CUI [1])
    C1272773 (UMLS CUI [2])
    Biochemistry - High Reference Value
    Item
    Biochemistry - High Reference Value
    float
    C0005477 (UMLS CUI [1])
    C1299400 (UMLS CUI [2])
    Item Group
    Laboratory Reference Ranges - Hepatic Function
    C0883335 (UMLS CUI-1)
    C0232741 (UMLS CUI-2)
    Item
    Hepatic function - Test
    integer
    C0232741 (UMLS CUI [1])
    C0022885 (UMLS CUI [2])
    Hepatic function - Test
    Code List
    Hepatic function - Test
    CL Item
    Total bilirubin (1)
    CL Item
    Aspartate transaminase (ASAT) (2)
    CL Item
    Alanine transaminase (ALAT) (3)
    CL Item
    Alkaline phosphatase (4)
    Hepatic function - Unit
    Item
    Hepatic function - Unit
    text
    C0232741 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Hepatic function - Low Reference Value
    Item
    Hepatic function - Low Reference Value
    float
    C0232741 (UMLS CUI [1])
    C1272773 (UMLS CUI [2])
    Hepatic function - High Reference Value
    Item
    Hepatic function - High Reference Value
    float
    C0232741 (UMLS CUI [1])
    C1299400 (UMLS CUI [2])
    Item Group
    Laboratory Reference Ranges - Renal Function
    C0883335 (UMLS CUI-1)
    C0232804 (UMLS CUI-2)
    Item
    Renal function - Test
    integer
    C0232804 (UMLS CUI [1])
    C0022885 (UMLS CUI [2])
    Renal function - Test
    Code List
    Renal function - Test
    CL Item
    Creatinine (1)
    Renal function - Unit
    Item
    Renal function - Unit
    text
    C0232804 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Renal function - Low Reference Value
    Item
    Renal function - Low Reference Value
    float
    C0232804 (UMLS CUI [1])
    C1272773 (UMLS CUI [2])
    Renal function - High Reference Value
    Item
    Renal function - High Reference Value
    float
    C0232804 (UMLS CUI [1])
    C1299400 (UMLS CUI [2])
    Item Group
    Use of human samples by GSK
    C2347026 (UMLS CUI-1)
    C0086418 (UMLS CUI-2)
    C0457083 (UMLS CUI-3)
    Item
    Use of human samples by GSK
    text
    C2347026 (UMLS CUI [1,1])
    C0086418 (UMLS CUI [1,2])
    C0457083 (UMLS CUI [1,3])
    Use of human samples by GSK
    Code List
    Use of human samples by GSK
    CL Item
    Quality Assurance of tests described in the protocol  (2)
    CL Item
    This may include the management of the quality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably. (This may include the management of the quality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably.)
    CL Item
    Further investigation by GSK Biologicals into the ability of the ASCI to protect people if any findings from related studies require it and further research in the melanoma. These investigation exclude genetics and HIV testing.  (3a)
    CL Item
    Further investigation by GSK Biologicals into the ability of the ASCI to protect people if any findings from related studies require it and further research in the melanoma. These investigations excludes genetic and HIV testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed. (3b)
    CL Item
    Further research by GSK Biologicals that is NOT RELATED to the ASCI or the melanoma done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic and HIV testing and does not affect subject participation in the study.  (4)
    CL Item
    Translational research by GSK Biologicals. This research does not affect subject participation in the study. (6)
    Item
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    integer
    C1698986 (UMLS CUI [1])
    C0449238 (UMLS CUI [2])
    C0021430 (UMLS CUI [3])
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    Code List
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    CL Item
    At least 15 years storage period by GSK Biologicals (1)
    CL Item
    Other, specify (2)
    Specify other storage period
    Item
    Specify other storage period
    text
    C1698986 (UMLS CUI [1])
    C0449238 (UMLS CUI [2])
    C0205394 (UMLS CUI [3])
    ICF Effective date
    Item
    ICF Effective date
    date
    C0011008 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Printed Investigator's name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Investigator's signature date
    Item
    Investigator's signature date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Ritorna all'inizio della pagina 

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