ID
44143
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 (3)
- 10/27/20 10/27/20 -
- 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 20, 2021
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
Screening - Primary Tumor Characteristics; Regional Lymph Node Status; Tumor Sample (Annex Report 2 Final Annex Report 2 Final)
Description
Primary Tumor Characteristics
Alias
- UMLS CUI-1
- C0027651
- UMLS CUI-2
- C1521970
Description
Has the primary tumor been identified?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C0205396
Description
Date of initial diagnosis of primary tumor:
Data type
date
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C2316983
Description
Primary site
Data type
integer
Alias
- UMLS CUI [1]
- C0475447
Description
If other primary site, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0475447
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Status of Primary Tumor:
Data type
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0475752
Description
Is there a recurrence of the primary tumor?
Data type
boolean
Alias
- UMLS CUI [1]
- C0677930
- UMLS CUI [2]
- C0034897
Description
If there is a recurrence of the primary tumor, record status
Data type
integer
Alias
- UMLS CUI [1]
- C0677930
- UMLS CUI [2]
- C0034897
- UMLS CUI [3]
- C0475752
Description
Breslow thickness (mm) :
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C1511325
Description
Regional Lymph Node Status
Alias
- UMLS CUI-1
- C1272833
Description
Was the regional lymph node invaded?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1269955
- UMLS CUI [1,2]
- C0024204
Description
If the regional lymph node was invaded, enter number of regional lymph node
Data type
integer
Alias
- UMLS CUI [1]
- C1269955
- UMLS CUI [2]
- C0729852
- UMLS CUI [3]
- C0237753
Description
If the regional lymph node was invaded, enter status of regional lymph node
Data type
integer
Alias
- UMLS CUI [1,1]
- C1269955
- UMLS CUI [1,2]
- C0729852
- UMLS CUI [2]
- C0449438
Description
If partially resected or resected, enter site of lymphadenectomy:
Data type
integer
Alias
- UMLS CUI [1,1]
- C0024203
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0024203
- UMLS CUI [1,4]
- C0441987
Description
If other site of lymphadenectomy, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0024203
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
Description
Was there a loco-regional recurrence in the lymph node?
Data type
boolean
Alias
- UMLS CUI [1]
- C0034897
- UMLS CUI [2,1]
- C0205147
- UMLS CUI [2,2]
- C0205276
- UMLS CUI [3]
- C0024204
Description
If there was there a loco-regional recurrence in the lymph node, record status of recurrence
Data type
integer
Alias
- UMLS CUI [1]
- C0034897
- UMLS CUI [2,1]
- C0205147
- UMLS CUI [2,2]
- C0205276
- UMLS CUI [3]
- C0024204
- UMLS CUI [4,1]
- C0034897
- UMLS CUI [4,2]
- C0449438
Description
Tumor Sample
Alias
- UMLS CUI-1
- C0475358
Description
Has a fresh biopsy been collected for Mage-A3 Expression test?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0677862
- UMLS CUI [1,2]
- C2827486
- UMLS CUI [2,1]
- C0677907
- UMLS CUI [2,2]
- C0017262
- UMLS CUI [2,3]
- C0022885
Description
Date of biopsy (fresh biopsy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0677862
- UMLS CUI [2,2]
- C2827486
Description
Requisition number (fresh biopsy):
Data type
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0677862
- UMLS CUI [2,2]
- C2827486
Description
Tumor biopsy type (fresh biopsy):
Data type
integer
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C0005558
- UMLS CUI [1,3]
- C0332307
- UMLS CUI [2,1]
- C0677862
- UMLS CUI [2,2]
- C2827486
Description
Has Formalin fixed Paraffin embedded (FFPE) been collected?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C2711483
Description
Date of biopsy (FFPE)
Data type
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C2711483
Description
Requisition number (FFPE):
Data type
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C2711483
Description
Tumor block or tumor slides? (FFPE)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [1,3]
- C2317347
- UMLS CUI [2,1]
- C0027651
- UMLS CUI [2,2]
- C1705201
- UMLS CUI [3]
- C2711483
Description
Number of tumor slides sent (FFPE)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C1705201
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [2]
- C2711483
Description
Does the FFPE come from the same lesion as the fresh biopsy?
Data type
boolean
Alias
- UMLS CUI [1]
- C2711483
- UMLS CUI [2,1]
- C0677862
- UMLS CUI [2,2]
- C2827486
- UMLS CUI [3,1]
- C0221198
- UMLS CUI [3,2]
- C0445247
Description
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
Data type
integer
Alias
- UMLS CUI [1]
- C2711483
- UMLS CUI [2,1]
- C0677862
- UMLS CUI [2,2]
- C2827486
- UMLS CUI [3,1]
- C0221198
- UMLS CUI [3,2]
- C0445247
- UMLS CUI [4]
- C2347029
Similar models
Screening - Primary Tumor Characteristics; Regional Lymph Node Status; Tumor Sample (Annex Report 2 Final Annex Report 2 Final)
C1521970 (UMLS CUI-2)
C0205396 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0475752 (UMLS CUI [1,2])
C0034897 (UMLS CUI [2])
C0034897 (UMLS CUI [2])
C0475752 (UMLS CUI [3])
C1511325 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
C0729852 (UMLS CUI [2])
C0237753 (UMLS CUI [3])
C0729852 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
C1515974 (UMLS CUI [1,2])
C0024203 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0205147 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0024204 (UMLS CUI [3])
C0205147 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0024204 (UMLS CUI [3])
C0034897 (UMLS CUI [4,1])
C0449438 (UMLS CUI [4,2])
C2827486 (UMLS CUI [1,2])
C0677907 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C2711483 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C1265611 (UMLS CUI [1,2])
C2317347 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1705201 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
C1705201 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2711483 (UMLS CUI [2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
C2347029 (UMLS CUI [4])