ID

41495

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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  1. 28.10.20 28.10.20 -
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GlaxoSmithKline

Hochgeladen am

28. Oktober 2020

DOI

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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

Englisch

Screening - Tumor Assessment; Baseline Melanoma Evaluation (Annex Report 2 Final)

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Tumor Assessment
Beschreibung

Tumor Assessment

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

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

Datentyp

boolean

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

Tumor Assessment

Alias
UMLS CUI-1
C3889740
Examination
Beschreibung

Examination

Datentyp

integer

Alias
UMLS CUI [1]
C4321457
Test Done
Beschreibung

Test Done

Datentyp

boolean

Alias
UMLS CUI [1]
C0039593
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Baseline Melanoma Evaluation
Beschreibung

Baseline Melanoma Evaluation

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

Date of evaluation

Datentyp

date

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

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
Beschreibung

Site

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
Method of evaluation
Beschreibung

Method of evaluation

Datentyp

integer

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

Other method of evaluation

Datentyp

text

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

Involvement

Datentyp

boolean

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

Non-target lesion

Datentyp

boolean

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

Target lesion(s) baseline evaluation

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

Lesion No

Datentyp

integer

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

Site target lesion

Datentyp

integer

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

Other site target lesion

Datentyp

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
Beschreibung

Method of evaluation

Datentyp

integer

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

Other method of evaluation

Datentyp

text

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

Longest Diameter

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1522425
mm
Target lesions
Beschreibung

Target lesions

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

(only one box must be ticked)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521840
UMLS CUI [2]
C0683312
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Ähnliche Modelle

Screening - Tumor Assessment; Baseline Melanoma Evaluation (Annex Report 2 Final)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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