ID

44143

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

Stichworte

Versionen (3)
  1. 27.10.20 27.10.20 -
  2. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  3. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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

Englisch

Screening - Primary Tumor Characteristics; Regional Lymph Node Status; Tumor Sample (Annex Report 2 Final 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
Primary Tumor Characteristics
Beschreibung

Primary Tumor Characteristics

Alias
UMLS CUI-1
C0027651
UMLS CUI-2
C1521970
Has the primary tumor been identified?
Beschreibung

Has the primary tumor been identified?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205396
Date of initial diagnosis of primary tumor:
Beschreibung

Date of initial diagnosis of primary tumor:

Datentyp

date

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2316983
Primary site
Beschreibung

Primary site

Datentyp

integer

Alias
UMLS CUI [1]
C0475447
If other primary site, please specify
Beschreibung

If other primary site, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0475447
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Status of Primary Tumor:
Beschreibung

Status of Primary Tumor:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0475752
Is there a recurrence of the primary tumor?
Beschreibung

Is there a recurrence of the primary tumor?

Datentyp

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2]
C0034897
If there is a recurrence of the primary tumor, record status
Beschreibung

If there is a recurrence of the primary tumor, record status

Datentyp

integer

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2]
C0034897
UMLS CUI [3]
C0475752
Breslow thickness (mm) :
Beschreibung

Breslow thickness (mm) :

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C1511325
Regional Lymph Node Status
Beschreibung

Regional Lymph Node Status

Alias
UMLS CUI-1
C1272833
Was the regional lymph node invaded?
Beschreibung

Was the regional lymph node invaded?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0024204
If the regional lymph node was invaded, enter number of regional lymph node
Beschreibung

If the regional lymph node was invaded, enter number of regional lymph node

Datentyp

integer

Alias
UMLS CUI [1]
C1269955
UMLS CUI [2]
C0729852
UMLS CUI [3]
C0237753
If the regional lymph node was invaded, enter status of regional lymph node
Beschreibung

If the regional lymph node was invaded, enter status of regional lymph node

Datentyp

integer

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0729852
UMLS CUI [2]
C0449438
If partially resected or resected, enter site/side of lymphadenectomy:
Beschreibung

If partially resected or resected, enter site of lymphadenectomy:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024203
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0024203
UMLS CUI [1,4]
C0441987
If other site of lymphadenectomy, specify
Beschreibung

If other site of lymphadenectomy, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0024203
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Was there a loco-regional recurrence in the lymph node?
Beschreibung

Was there a loco-regional recurrence in the lymph node?

Datentyp

boolean

Alias
UMLS CUI [1]
C0034897
UMLS CUI [2,1]
C0205147
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0024204
If there was there a loco-regional recurrence in the lymph node, record status of recurrence
Beschreibung

If there was there a loco-regional recurrence in the lymph node, record status of recurrence

Datentyp

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
Tumor Sample
Beschreibung

Tumor Sample

Alias
UMLS CUI-1
C0475358
Has a fresh biopsy been collected for Mage-A3 Expression test?
Beschreibung

Has a fresh biopsy been collected for Mage-A3 Expression test?

Datentyp

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
Date of biopsy (fresh biopsy)
Beschreibung

Date of biopsy (fresh biopsy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0677862
UMLS CUI [2,2]
C2827486
Requisition number (fresh biopsy):
Beschreibung

Requisition number (fresh biopsy):

Datentyp

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0677862
UMLS CUI [2,2]
C2827486
Tumor biopsy type (fresh biopsy):
Beschreibung

Tumor biopsy type (fresh biopsy):

Datentyp

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
Has Formalin fixed Paraffin embedded (FFPE) been collected?
Beschreibung

Has Formalin fixed Paraffin embedded (FFPE) been collected?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2711483
Date of biopsy (FFPE)
Beschreibung

Date of biopsy (FFPE)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C2711483
Requisition number (FFPE):
Beschreibung

Requisition number (FFPE):

Datentyp

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C2711483
Tumor block or tumor slides? (FFPE)
Beschreibung

Tumor block or tumor slides? (FFPE)

Datentyp

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
Number of tumor slides sent (FFPE)
Beschreibung

Number of tumor slides sent (FFPE)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1705201
UMLS CUI [1,3]
C0237753
UMLS CUI [2]
C2711483
Does the FFPE come from the same lesion as the fresh biopsy?
Beschreibung

Does the FFPE come from the same lesion as the fresh biopsy?

Datentyp

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
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
Beschreibung

If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type

Datentyp

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
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Ähnliche Modelle

Screening - Primary Tumor Characteristics; Regional Lymph Node Status; Tumor Sample (Annex Report 2 Final 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
Primary Tumor Characteristics
C0027651 (UMLS CUI-1)
C1521970 (UMLS CUI-2)
Has the primary tumor been identified?
Item
Has the primary tumor been identified?
boolean
C0027651 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
Date of initial diagnosis of primary tumor:
Item
Date of initial diagnosis of primary tumor:
date
C0677930 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item
Primary site
integer
C0475447 (UMLS CUI [1])
Primary site
Code List
Primary site
CL Item
Head (1)
CL Item
Neck (2)
CL Item
Upper extremity (3)
CL Item
Lower extremity (4)
CL Item
Trunk (5)
CL Item
Unknown (6)
CL Item
Other, specify (7)
If other primary site, please specify
Item
If other primary site, please specify
text
C0475447 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Status of Primary Tumor:
integer
C0677930 (UMLS CUI [1,1])
C0475752 (UMLS CUI [1,2])
Status of Primary Tumor:
Code List
Status of Primary Tumor:
CL Item
Unresected (1)
CL Item
Partially resected (2)
CL Item
Resected (3)
CL Item
Unknown (4)
Is there a recurrence of the primary tumor?
Item
Is there a recurrence of the primary tumor?
boolean
C0677930 (UMLS CUI [1])
C0034897 (UMLS CUI [2])
Item
If there is a recurrence of the primary tumor, record status
integer
C0677930 (UMLS CUI [1])
C0034897 (UMLS CUI [2])
C0475752 (UMLS CUI [3])
If there is a recurrence of the primary tumor, record status
Code List
If there is a recurrence of the primary tumor, record status
CL Item
Unresected (1)
CL Item
Partially resected (2)
CL Item
Resected (3)
Item
Breslow thickness (mm) :
integer
C0242485 (UMLS CUI [1,1])
C1511325 (UMLS CUI [1,2])
Breslow thickness (mm) :
Code List
Breslow thickness (mm) :
CL Item
≤1.0 mm (1)
CL Item
1.01 mm- 2.0 mm (2)
CL Item
2.01 mm- 4.0 mm (3)
CL Item
> 4.0 mm (4)
Item Group
Regional Lymph Node Status
C1272833 (UMLS CUI-1)
Was the regional lymph node invaded?
Item
Was the regional lymph node invaded?
boolean
C1269955 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Item
If the regional lymph node was invaded, enter number of regional lymph node
integer
C1269955 (UMLS CUI [1])
C0729852 (UMLS CUI [2])
C0237753 (UMLS CUI [3])
If the regional lymph node was invaded, enter number of regional lymph node
Code List
If the regional lymph node was invaded, enter number of regional lymph node
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
3+ (4)
CL Item
Matted nodes (5)
CL Item
Unknown (6)
Item
If the regional lymph node was invaded, enter status of regional lymph node
integer
C1269955 (UMLS CUI [1,1])
C0729852 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
If the regional lymph node was invaded, enter status of regional lymph node
Code List
If the regional lymph node was invaded, enter status of regional lymph node
CL Item
Unresected (1)
CL Item
Partially resected (2)
CL Item
Resected (3)
Item
If partially resected or resected, enter site/side of lymphadenectomy:
integer
C0024203 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0024203 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
If partially resected or resected, enter site of lymphadenectomy:
Code List
If partially resected or resected, enter site/side of lymphadenectomy:
CL Item
Head and neck (1)
CL Item
Axiliary (2)
CL Item
Iliac (3)
CL Item
Femoral (4)
CL Item
Left (5)
CL Item
Right (6)
CL Item
Both (7)
CL Item
Other, specify (8)
If other site of lymphadenectomy, specify
Item
If other site of lymphadenectomy, specify
text
C0024203 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Was there a loco-regional recurrence in the lymph node?
Item
Was there a loco-regional recurrence in the lymph node?
boolean
C0034897 (UMLS CUI [1])
C0205147 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0024204 (UMLS CUI [3])
Item
If there was there a loco-regional recurrence in the lymph node, record status of recurrence
integer
C0034897 (UMLS CUI [1])
C0205147 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0024204 (UMLS CUI [3])
C0034897 (UMLS CUI [4,1])
C0449438 (UMLS CUI [4,2])
If there was there a loco-regional recurrence in the lymph node, record status of recurrence
Code List
If there was there a loco-regional recurrence in the lymph node, record status of recurrence
CL Item
Unresected (1)
CL Item
Partially resected (2)
CL Item
Resected (3)
Item Group
Tumor Sample
C0475358 (UMLS CUI-1)
Has a fresh biopsy been collected for Mage-A3 Expression test?
Item
Has a fresh biopsy been collected for Mage-A3 Expression test?
boolean
C0677862 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C0677907 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
Date of biopsy (fresh biopsy)
Item
Date of biopsy (fresh biopsy)
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Requisition number (fresh biopsy):
Item
Requisition number (fresh biopsy):
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Item
Tumor biopsy type (fresh biopsy):
integer
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Tumor biopsy type:
Code List
Tumor biopsy type (fresh biopsy):
CL Item
Skin (1)
CL Item
Subcutaneous (2)
CL Item
Lymphnode (3)
Has Formalin fixed Paraffin embedded (FFPE) been collected?
Item
Has Formalin fixed Paraffin embedded (FFPE) been collected?
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
Date of biopsy (FFPE)
Item
Date of biopsy (FFPE)
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Requisition number (FFPE):
Item
Requisition number (FFPE):
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Item
Tumor block or tumor slides? (FFPE)
integer
C0475358 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2317347 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1705201 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
Tumor block or tumor slides? (FFPE)
Code List
Tumor block or tumor slides? (FFPE)
CL Item
Tumor block (1)
CL Item
Tumor slides (2)
Number of tumor slides sent (FFPE)
Item
Number of tumor slides sent (FFPE)
integer
C0027651 (UMLS CUI [1,1])
C1705201 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2711483 (UMLS CUI [2])
Does the FFPE come from the same lesion as the fresh biopsy?
Item
Does the FFPE come from the same lesion as the fresh biopsy?
boolean
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
Item
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
integer
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
C2347029 (UMLS CUI [4])
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
Code List
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
CL Item
Skin (1)
CL Item
Subcutaneous (2)
CL Item
Lymphnode (3)
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