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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
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- 24.10.20 24.10.20 -
- 03.11.20 03.11.20 -
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GlaxoSmithKline
Hochgeladen am
24. Oktober 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
Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature
Ähnliche Modelle
Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Centre
Item
Centre
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
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])
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])
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])
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])
C1514721 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
CL Item
Years (1)
CL Item
Month (2)
CL Item
Weeks (3)
CL Item
Days (4)
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)
C0018941 (UMLS CUI-2)
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])
C1519795 (UMLS CUI [1,2])
Haematology - Low Reference Value
Item
Haematology - Low Reference Value
float
C0018941 (UMLS CUI [1])
C1272773 (UMLS CUI [2])
C1272773 (UMLS CUI [2])
Haematology - High Reference Value
Item
Haematology - High Reference Value
float
C0018941 (UMLS CUI [1])
C1299400 (UMLS CUI [2])
C1299400 (UMLS CUI [2])
Item Group
Laboratory Reference Ranges - Biochemistry
C0883335 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
C0005477 (UMLS CUI-2)
CL Item
LDH (1)
Biochemistry - Unit
Item
Biochemistry - Unit
text
C0005477 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Biochemistry - Low Reference Value
Item
Biochemistry - Low Reference Value
float
C0005477 (UMLS CUI [1])
C1272773 (UMLS CUI [2])
C1272773 (UMLS CUI [2])
Biochemistry - High Reference Value
Item
Biochemistry - High Reference Value
float
C0005477 (UMLS CUI [1])
C1299400 (UMLS CUI [2])
C1299400 (UMLS CUI [2])
Item Group
Laboratory Reference Ranges - Hepatic Function
C0883335 (UMLS CUI-1)
C0232741 (UMLS CUI-2)
C0232741 (UMLS CUI-2)
Item
Hepatic function - Test
integer
C0232741 (UMLS CUI [1])
C0022885 (UMLS CUI [2])
C0022885 (UMLS CUI [2])
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])
C1519795 (UMLS CUI [2])
Hepatic function - Low Reference Value
Item
Hepatic function - Low Reference Value
float
C0232741 (UMLS CUI [1])
C1272773 (UMLS CUI [2])
C1272773 (UMLS CUI [2])
Hepatic function - High Reference Value
Item
Hepatic function - High Reference Value
float
C0232741 (UMLS CUI [1])
C1299400 (UMLS CUI [2])
C1299400 (UMLS CUI [2])
Item Group
Laboratory Reference Ranges - Renal Function
C0883335 (UMLS CUI-1)
C0232804 (UMLS CUI-2)
C0232804 (UMLS CUI-2)
Item
Renal function - Test
integer
C0232804 (UMLS CUI [1])
C0022885 (UMLS CUI [2])
C0022885 (UMLS CUI [2])
CL Item
Creatinine (1)
Renal function - Unit
Item
Renal function - Unit
text
C0232804 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Renal function - Low Reference Value
Item
Renal function - Low Reference Value
float
C0232804 (UMLS CUI [1])
C1272773 (UMLS CUI [2])
C1272773 (UMLS CUI [2])
Renal function - High Reference Value
Item
Renal function - High Reference Value
float
C0232804 (UMLS CUI [1])
C1299400 (UMLS CUI [2])
C1299400 (UMLS CUI [2])
Item Group
Use of human samples by GSK
C2347026 (UMLS CUI-1)
C0086418 (UMLS CUI-2)
C0457083 (UMLS CUI-3)
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])
C0086418 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,3])
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])
C0449238 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
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])
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])
C0009797 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])