ID

41495

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. 10/28/20 10/28/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 28, 2020

DOI

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License

Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

English

Screening - Tumor Assessment; Baseline Melanoma Evaluation (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
Tumor Assessment
Description

Tumor Assessment

Alias
UMLS CUI-1
C3889740
Has the baseline tumor assessment been performed?
Description

Yes → Please specify if any of the following assessment have been performed.

Data type

boolean

Alias
UMLS CUI [1,1]
C3889740
UMLS CUI [1,2]
C1442488
Tumor Assessment
Description

Tumor Assessment

Alias
UMLS CUI-1
C3889740
Examination
Description

Examination

Data type

integer

Alias
UMLS CUI [1]
C4321457
Test Done
Description

Test Done

Data type

boolean

Alias
UMLS CUI [1]
C0039593
Test Date
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Baseline Melanoma Evaluation
Description

Baseline Melanoma Evaluation

Alias
UMLS CUI-1
C0025202
UMLS CUI-2
C0220825
UMLS CUI-3
C1442488
Date of evaluation
Description

Date of evaluation

Data type

date

Alias
UMLS CUI [1]
C2985720
Site and non-target lesions baseline evaluation
Description

Site and non-target lesions baseline evaluation

Alias
UMLS CUI-1
C1515974
UMLS CUI-2
C1518389
UMLS CUI-3
C0221198
UMLS CUI-4
C0220825
UMLS CUI-5
C1442488
Site
Description

Site

Data type

integer

Alias
UMLS CUI [1]
C1515974
Method of evaluation
Description

Method of evaluation

Data type

integer

Alias
UMLS CUI [1]
C2911685
Other method of evaluation
Description

Other method of evaluation

Data type

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0205394
Involvement
Description

Involvement

Data type

boolean

Alias
UMLS CUI [1]
C1314939
Non-target lesion
Description

Non-target lesion

Data type

boolean

Alias
UMLS CUI [1]
C2986547
Target lesion(s) baseline evaluation
Description

Target lesion(s) baseline evaluation

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1521840
UMLS CUI-3
C0220825
UMLS CUI-4
C1442488
Lesion No
Description

Lesion No

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0221198
Site target lesion
Description

Site target lesion

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
Other site target lesion
Description

Other site target lesion

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0205394
Method of evaluation
Description

Method of evaluation

Data type

integer

Alias
UMLS CUI [1]
C2911685
Other method of evaluation
Description

Other method of evaluation

Data type

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0205394
Longest Diameter
Description

Longest Diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1522425
mm
Target lesions
Description

Target lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1521840
Please specify the target lesions category:
Description

(only one box must be ticked)

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521840
UMLS CUI [2]
C0683312
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Similar models

Screening - Tumor Assessment; Baseline Melanoma Evaluation (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
Tumor Assessment
C3889740 (UMLS CUI-1)
Has the baseline tumor assessment been performed?
Item
Has the baseline tumor assessment been performed?
boolean
C3889740 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Tumor Assessment
C3889740 (UMLS CUI-1)
Item
Examination
integer
C4321457 (UMLS CUI [1])
Examination
Code List
Examination
CL Item
Clinical examination (1)
CL Item
Chest CT Scan (2)
CL Item
Complete Abdomen CT Scan (3)
CL Item
Contrast-Enhanced CT Scan of the brain (4)
CL Item
Brain MRI (5)
CL Item
Ultrasound of lymph node lesions (6)
CL Item
Ultrasound of subcutaneous lesions (7)
CL Item
Photography of superficial cutaneous lesions (with metrics notation) (8)
CL Item
Other, specify (9)
Test Done
Item
Test Done
boolean
C0039593 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Item Group
Baseline Melanoma Evaluation
C0025202 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1442488 (UMLS CUI-3)
Date of evaluation
Item
Date of evaluation
date
C2985720 (UMLS CUI [1])
Item Group
Site and non-target lesions baseline evaluation
C1515974 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
C0221198 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C1442488 (UMLS CUI-5)
Item
Site
integer
C1515974 (UMLS CUI [1])
Site
Code List
Site
CL Item
Primary tumor/recurrence (1)
CL Item
Lymphnode regional (2)
CL Item
Lymphnode distant (3)
CL Item
Cutaneous/subcutaneous regional (4)
CL Item
Cutaneous/subcutaneous distant (5)
CL Item
Confluent skin lesions regional (6)
CL Item
Confluent skin lesions distant (7)
CL Item
Lung (9)
CL Item
Brain (10)
CL Item
Other site (99)
Item
Method of evaluation
integer
C2911685 (UMLS CUI [1])
Method of evaluation
Code List
Method of evaluation
CL Item
Photography (1)
CL Item
X-ray (2)
CL Item
Ultrasound (3)
CL Item
Conventional CT-scan (4)
CL Item
Spiral CT-scan (5)
CL Item
MRI (6)
CL Item
Other (7)
CL Item
Clinical examination (8)
CL Item
Not done (9)
Other method of evaluation
Item
Other method of evaluation
text
C2911685 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Involvement
Item
Involvement
boolean
C1314939 (UMLS CUI [1])
Non-target lesion
Item
Non-target lesion
boolean
C2986547 (UMLS CUI [1])
Item Group
Target lesion(s) baseline evaluation
C0221198 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1442488 (UMLS CUI-4)
Lesion No
Item
Lesion No
integer
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Site target lesion
integer
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
Site target lesion
Code List
Site target lesion
CL Item
Primary tumor/recurrence (1)
CL Item
Lymphnode regional (2)
CL Item
Lymphnode distant (3)
CL Item
Cutaneous/subcutaneous regional (4)
CL Item
Cutaneous/subcutaneous distant (5)
CL Item
Confluent skin lesions regional (6)
CL Item
Confluent skin lesions distant (7)
CL Item
Other site (99)
Other site target lesion
Item
Other site target lesion
text
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Method of evaluation
integer
C2911685 (UMLS CUI [1])
Method of evaluation
Code List
Method of evaluation
CL Item
Photography (1)
CL Item
X-ray (2)
CL Item
Ultrasound (3)
CL Item
Conventional CT-scan (4)
CL Item
Spiral CT-scan (5)
CL Item
MRI (6)
CL Item
Other (7)
CL Item
Clinical examination (8)
CL Item
Not done (9)
Other method of evaluation
Item
Other method of evaluation
text
C2911685 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Longest Diameter
Item
Longest Diameter
integer
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1522425 (UMLS CUI [1,3])
Item Group
Target lesions
C0221198 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
Item
Please specify the target lesions category:
integer
C0221198 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0683312 (UMLS CUI [2])
Please specify the target lesions category: (only one box must be ticked)
Code List
Please specify the target lesions category:
CL Item
All target lesions >= 20 mm (≥ 10 mm with spiral CT-scan) (1)
CL Item
All target lesions < 20 mm (< 10 mm with spiral CT-scan) (2)
CL Item
Both target lesions >= 20 mm and < 20 mm (3)
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