ID

41487

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 (1)
  1. 10/27/20 10/27/20 -
Copyright Holder

GlaxoSmithKline

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October 27, 2020

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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

English

Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics (Annex Report 2 Final)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date for Study Participation (ICF Model A)
Description

I certify that Informed Consent has been obtained for full study participation.

Data type

date

Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C2348568
Did the patient allow a new biopsy to collect some more cancer tissue in the rare case the analysis of the first specimen biopsy would give an inconclusive result?
Description

Did the patient allow a new biopsy to collect some more cancer tissue in the rare case the analysis of the first specimen biopsy would give an inconclusive result?

Data type

boolean

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2,1]
C0040300
UMLS CUI [2,2]
C1516225
UMLS CUI [3]
C1629507
Optional Translational Research and other Research
Description

Optional Translational Research and other Research

Alias
UMLS CUI-1
C3494163
UMLS CUI-2
C1518600
UMLS CUI-3
C0035168
UMLS CUI-4
C0205394
Did the patient agree that her/his blood and tumor samples may be used by GSK Biologicals for “translational research”?
Description

Did the patient agree that her/his blood and tumor samples may be used by GSK Biologicals for “translational research”?

Data type

text

Alias
UMLS CUI [1]
C3641827
UMLS CUI [2]
C0178913
UMLS CUI [3]
C0475358
UMLS CUI [4]
C0457083
UMLS CUI [5]
C3494163
Did the patient agree that her/his blood samples may be used by GSK Biologicals for “additional research on the MAGE-A3 ASCI product and melanoma”, if new developments make this desirable? Testing on the heredity or testing for AIDS or HIV infection will not be done.
Description

Blood specimen | research; Additional | MAGEA3 gene | melanoma

Data type

text

Alias
UMLS CUI [1]
C3641827
UMLS CUI [2]
C0178913
UMLS CUI [3,1]
C0035168
UMLS CUI [3,2]
C1524062
UMLS CUI [4]
C0677907
UMLS CUI [5]
C0025202
UMLS CUI [6]
C0220848
UMLS CUI [7]
C0001175
UMLS CUI [8]
C0019693
Did the patient agree that her/his blood samples may be used by GSK Biologicals for further research that is NOT RELATED to the MAGE-A3 ASCI product or melanoma? This will be done on an anonymous basis (meaning that any identification linking the patient to the sample is destroyed). Testing on the heredity or testing for AIDS or HIV infection will not be done.
Description

Agree | Blood specimen | research; Additional | MAGEA3 gene | melanoma | Anonymous | Heredity aspects | Acquired Immunodeficiency Syndrome

Data type

text

Alias
UMLS CUI [1]
C3641827
UMLS CUI [2]
C0178913
UMLS CUI [3,1]
C0035168
UMLS CUI [3,2]
C1524062
UMLS CUI [4]
C0677907
UMLS CUI [5]
C0025202
UMLS CUI [6]
C2346787
UMLS CUI [7]
C0220848
UMLS CUI [8]
C0001175
UMLS CUI [9]
C0019693
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
If female, is the patient of childbearing potential?
Description

If female, is the patient of childbearing potential?

Data type

boolean

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
If other race, specify
Description

If other race, specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Cutaneous Melanoma: Disease chracteristics
Description

Cutaneous Melanoma: Disease chracteristics

Alias
UMLS CUI-1
C0151779
UMLS CUI-2
C0012634
UMLS CUI-3
C1521970
Date of diagnosis of metastatic disease
Description

Date of diagnosis of metastatic disease

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027627
Pathological disease stage (pTNM)
Description

Pathological disease stage (pTNM)

Data type

integer

Alias
UMLS CUI [1]
C1319019
If N3: In-transit metastasis?
Description

If N3: In-transit metastasis?

Data type

boolean

Alias
UMLS CUI [1]
C1319019
UMLS CUI [2]
C2985554
Pathological disease stage (AJCC)
Description

Pathological disease stage (AJCC)

Data type

integer

Alias
UMLS CUI [1]
C0441915
Is disease amenable to curative treatment with surgery?
Description

Is disease amenable to curative treatment with surgery?

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1880198
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Similar models

Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics (Annex Report 2 Final)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date for Study Participation (ICF Model A)
Item
Informed Consent Date for Study Participation (ICF Model A)
date
C2985782 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Did the patient allow a new biopsy to collect some more cancer tissue in the rare case the analysis of the first specimen biopsy would give an inconclusive result?
Item
Did the patient allow a new biopsy to collect some more cancer tissue in the rare case the analysis of the first specimen biopsy would give an inconclusive result?
boolean
C0005558 (UMLS CUI [1])
C0040300 (UMLS CUI [2,1])
C1516225 (UMLS CUI [2,2])
C1629507 (UMLS CUI [3])
Item Group
Optional Translational Research and other Research
C3494163 (UMLS CUI-1)
C1518600 (UMLS CUI-2)
C0035168 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
Did the patient agree that her/his blood and tumor samples may be used by GSK Biologicals for “translational research”?
text
C3641827 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C0475358 (UMLS CUI [3])
C0457083 (UMLS CUI [4])
C3494163 (UMLS CUI [5])
Did the patient agree that her/his blood and tumor samples may be used by GSK Biologicals for “translational research”?
Code List
Did the patient agree that her/his blood and tumor samples may be used by GSK Biologicals for “translational research”?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
NA (NA)
Item
Did the patient agree that her/his blood samples may be used by GSK Biologicals for “additional research on the MAGE-A3 ASCI product and melanoma”, if new developments make this desirable? Testing on the heredity or testing for AIDS or HIV infection will not be done.
text
C3641827 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C0035168 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0677907 (UMLS CUI [4])
C0025202 (UMLS CUI [5])
C0220848 (UMLS CUI [6])
C0001175 (UMLS CUI [7])
C0019693 (UMLS CUI [8])
undefined item
Code List
Did the patient agree that her/his blood samples may be used by GSK Biologicals for “additional research on the MAGE-A3 ASCI product and melanoma”, if new developments make this desirable? Testing on the heredity or testing for AIDS or HIV infection will not be done.
CL Item
Yes (Y)
CL Item
No (N)
CL Item
NA (NA)
Item
Did the patient agree that her/his blood samples may be used by GSK Biologicals for further research that is NOT RELATED to the MAGE-A3 ASCI product or melanoma? This will be done on an anonymous basis (meaning that any identification linking the patient to the sample is destroyed). Testing on the heredity or testing for AIDS or HIV infection will not be done.
text
C3641827 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C0035168 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0677907 (UMLS CUI [4])
C0025202 (UMLS CUI [5])
C2346787 (UMLS CUI [6])
C0220848 (UMLS CUI [7])
C0001175 (UMLS CUI [8])
C0019693 (UMLS CUI [9])
undefined item
Code List
Did the patient agree that her/his blood samples may be used by GSK Biologicals for further research that is NOT RELATED to the MAGE-A3 ASCI product or melanoma? This will be done on an anonymous basis (meaning that any identification linking the patient to the sample is destroyed). Testing on the heredity or testing for AIDS or HIV infection will not be done.
CL Item
Yes (Y)
CL Item
No (N)
CL Item
NA (NA)
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
If female, is the patient of childbearing potential?
Item
If female, is the patient of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify (10)
If other race, specify
Item
If other race, specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Cutaneous Melanoma: Disease chracteristics
C0151779 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C1521970 (UMLS CUI-3)
Date of diagnosis of metastatic disease
Item
Date of diagnosis of metastatic disease
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Item
Pathological disease stage (pTNM)
integer
C1319019 (UMLS CUI [1])
Pathological disease stage (pTNM)
Code List
Pathological disease stage (pTNM)
CL Item
TX (1)
CL Item
T0 (2)
CL Item
T1 (3)
CL Item
T1a (4)
CL Item
T1b (5)
CL Item
T1 Unknown (6)
CL Item
T2 (7)
CL Item
T2a (8)
CL Item
T2b (9)
CL Item
T2 Unknown (10)
CL Item
T3 (11)
CL Item
T3a (12)
CL Item
T3b (13)
CL Item
T3 Unknown (14)
CL Item
T4 (15)
CL Item
T4a (16)
CL Item
T4b (17)
CL Item
T4 Unknown (18)
CL Item
NX (19)
CL Item
N0 (20)
CL Item
N1 (21)
CL Item
N1a (22)
CL Item
N1b (23)
CL Item
N1 Unknown (24)
CL Item
N2 (25)
CL Item
N2a (26)
CL Item
N2b (27)
CL Item
N2c (28)
CL Item
N2 Unknown (29)
CL Item
N3 (30)
CL Item
MX (31)
CL Item
M0 (32)
CL Item
M1 (33)
CL Item
M1a (34)
CL Item
M1b (35)
CL Item
M1c (36)
CL Item
M1 Unknown (37)
If N3: In-transit metastasis?
Item
If N3: In-transit metastasis?
boolean
C1319019 (UMLS CUI [1])
C2985554 (UMLS CUI [2])
Item
Pathological disease stage (AJCC)
integer
C0441915 (UMLS CUI [1])
Pathological disease stage (AJCC)
Code List
Pathological disease stage (AJCC)
CL Item
Stage 0 (1)
CL Item
Stage IA (2)
CL Item
Stage IB (3)
CL Item
Stage IIA (4)
CL Item
Stage IIB (5)
CL Item
Stage IIC (6)
CL Item
Stage IIIA (7)
CL Item
Stage IIIB (8)
CL Item
Stage IIIC (9)
CL Item
Stage IV (10)
Is disease amenable to curative treatment with surgery?
Item
Is disease amenable to curative treatment with surgery?
boolean
C0012634 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1880198 (UMLS CUI [1,3])
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