ID

28264

Description

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Keywords

Versions (3)
  1. 12/7/17 12/7/17 -
  2. 12/7/17 12/7/17 -
  3. 1/1/18 1/1/18 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

January 1, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Staging GOAL Trial B-cell Lymphoma NCT02499003

English

Staging GOAL Trial B-cell Lymphoma NCT02499003

1 forms  
Admininstrative data
Description

Admininstrative data

Alias
UMLS CUI-1
C1320722
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Staging
Description

Staging

Alias
UMLS CUI-1
C0699749
Staging date
Description

Staging date

Data type

date

Alias
UMLS CUI [1,1]
C0027646
UMLS CUI [1,2]
C0011008
Method
Description

Method

Data type

text

Alias
UMLS CUI [1]
C0871511
If applicable: Reason for not using contrast agent
Description

indication

Data type

text

Alias
UMLS CUI [1]
C3146298
PET Scan performed?
Description

PET Scan performed

Data type

boolean

Alias
UMLS CUI [1,1]
C1512699
UMLS CUI [1,2]
C0203668
If "yes": PET Scan is
Description

PET scan result

Data type

text

Alias
UMLS CUI [1,1]
C1512699
UMLS CUI [1,2]
C0203668
If PET Scan is positive: please specify
Description

specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Target Lesions
Description

Target Lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1521840
No.
Description

Target lesion number

Data type

integer

Alias
UMLS CUI [1]
C2986546
Localisation
Description

N = Node, O = Organ

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
Specification localisation
Description

specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Side
Description

Side target lesion

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0475445
Measurable?
Description

Measurable target lesion

Data type

text

Alias
UMLS CUI [1,1]
C1513040
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
Size
Description

Size target lesion

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
mm
Size
Description

Size target lesion

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
mm
Target lesions: Sum of sizes
Description

Target lesions: Sum of sizes

Alias
UMLS CUI-1
C0234108
UMLS CUI-2
C0456389
UMLS CUI-3
C0221198
UMLS CUI-4
C1521840
Sum
Description

sum target lesion sizes

Data type

integer

Measurement units
  • mm2
Alias
UMLS CUI [1,1]
C0234108
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0221198
UMLS CUI [1,4]
C1521840
mm2
Other lesions: Pre-existing non-target lesions
Description

Other lesions: Pre-existing non-target lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1518389
No.
Description

lesion number

Data type

integer

Alias
UMLS CUI [1]
C0449791
Localisation
Description

N = Node, O = Organ

Data type

integer

Specification localisation
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Still present?
Description

lesion present

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0150312
Progression?
Description

progression lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0221198
Other lesions: New lesions
Description

Other lesions: New lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C0205314
Have any new lesions been identified?
Description

new lesions

Data type

boolean

Alias
UMLS CUI [1]
C2986548
Other lesions: Localisation of new lesions
Description

Other lesions: Localisation of new lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C0205314
Localisation
Description

N=Node, O=Organ

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1518389
If necessary, specify localisation:
Description

specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Tumor Assessment
Description

Tumor Assessment

Alias
UMLS CUI-1
C3889740
CR
Description

Complete Response

Data type

boolean

Alias
UMLS CUI [1]
C0677874
CRu
Description

complete remission unconfirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C1547326
PR
Description

Partial Response

Data type

boolean

Alias
UMLS CUI [1]
C1521726
SD
Description

tumor assessment SD

Data type

boolean

Alias
UMLS CUI [1]
C0677946
PD
Description

Progressive Disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
Unknown
Description

Unknown

Data type

boolean

Alias
UMLS CUI [1]
C0439673
EoT: In case of PR or less: Tumor biopsy performed?
Description

Item only applicable during the following visit: end of Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0677862
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Similar models

Staging GOAL Trial B-cell Lymphoma NCT02499003

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Admininstrative data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Item
Visit
text
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Interim Staging (Interim Staging)
C0699749 (UMLS CUI-1)
(Comment:en)
CL Item
End of Treatment (End of Treatment)
C0580352 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up 2 (Follow Up 2)
C1522577 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up 4 (Follow Up 4)
(Comment:en)
CL Item
Follow Up 6 (Follow Up 6)
(Comment:en)
CL Item
Follow Up 8 (Follow Up 8)
(Comment:en)
Item Group
Staging
C0699749 (UMLS CUI-1)
Staging date
Item
Staging date
date
C0027646 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Method
text
C0871511 (UMLS CUI [1])
Method
Code List
Method
CL Item
Contrast CT (Contrast CT)
C0742919 (UMLS CUI-1)
(Comment:en)
CL Item
Non-contrast CT (Non-contrast CT)
C0040405 (UMLS CUI-1)
(Comment:en)
CL Item
MRI (MRI)
C0024485 (UMLS CUI-1)
(Comment:en)
CL Item
Not done (Not done)
C1272696 (UMLS CUI-1)
(Comment:en)
indication
Item
If applicable: Reason for not using contrast agent
text
C3146298 (UMLS CUI [1])
PET Scan performed
Item
PET Scan performed?
boolean
C1512699 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
Item
If "yes": PET Scan is
text
C1512699 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
PET scan result
Code List
If "yes": PET Scan is
CL Item
Positive (Positive)
C1446409 (UMLS CUI-1)
(Comment:en)
CL Item
Negative (Negative)
C0205160 (UMLS CUI-1)
(Comment:en)
specify
Item
If PET Scan is positive: please specify
text
C1521902 (UMLS CUI [1])
Item Group
Target Lesions
C0221198 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
Item
No.
integer
C2986546 (UMLS CUI [1])
Target lesion number
Code List
No.
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
Item
Localisation
integer
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
Localisation target lesion
Code List
Localisation
CL Item
N: Waldeyer Ring (1)
C0459892 (UMLS CUI-1)
C0806692 (UMLS CUI-2)
(Comment:en)
CL Item
N: cervical (2)
C0588054 (UMLS CUI-1)
(Comment:en)
CL Item
N: supraclavicular (3)
C0229730 (UMLS CUI-1)
(Comment:en)
CL Item
N: infraclavicular (4)
C0229743 (UMLS CUI-1)
(Comment:en)
CL Item
N: axillar (5)
C0729594 (UMLS CUI-1)
(Comment:en)
CL Item
N: mediastinal (6)
C0588055 (UMLS CUI-1)
(Comment:en)
CL Item
N: hilar (7)
C1305372 (UMLS CUI-1)
(Comment:en)
CL Item
N: porta hepatic (8)
C0229769 (UMLS CUI-1)
(Comment:en)
CL Item
N: retroperitoneal (9)
C0229802 (UMLS CUI-1)
(Comment:en)
CL Item
N: retrocrural (10)
C2953130 (UMLS CUI-1)
(Comment:en)
CL Item
N: paraaortic (11)
CL Item
N: mesenteric (12)
CL Item
N: iliac (13)
CL Item
N: inguinal/femoral (14)
CL Item
O: tonsils (15)
CL Item
O: thymus (16)
CL Item
O: lung (17)
CL Item
O: liver (18)
CL Item
O: spleen (19)
CL Item
O: digestive tract (20)
CL Item
O: bone marrow (21)
CL Item
Other (22)
specification
Item
Specification localisation
text
C2348235 (UMLS CUI [1])
Item
Side
text
C0441987 (UMLS CUI [1,1])
C0475445 (UMLS CUI [1,2])
Side target lesion
Code List
Side
CL Item
Left (Left)
CL Item
Right (Right)
CL Item
N.a. (N.a.)
Item
Measurable?
text
C1513040 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
Measurable target lesion
Code List
Measurable?
CL Item
Measurable (Measurable)
CL Item
Not Measurable (Not Measurable)
CL Item
Not Done (Not Done)
Size target lesion
Item
Size
integer
C0456389 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
Size target lesion
Item
Size
integer
C0456389 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
Item Group
Target lesions: Sum of sizes
C0234108 (UMLS CUI-1)
C0456389 (UMLS CUI-2)
C0221198 (UMLS CUI-3)
C1521840 (UMLS CUI-4)
sum target lesion sizes
Item
Sum
integer
C0234108 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C1521840 (UMLS CUI [1,4])
Item Group
Other lesions: Pre-existing non-target lesions
C0221198 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
Item
No.
integer
C0449791 (UMLS CUI [1])
lesion number
Code List
No.
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
Item
Localisation
integer
Localisation target lesion
Code List
Localisation
CL Item
N: Waldeyer Ring (1)
C0459892 (UMLS CUI-1)
C0806692 (UMLS CUI-2)
(Comment:en)
CL Item
N: cervical (2)
C0588054 (UMLS CUI-1)
(Comment:en)
CL Item
N: supraclavicular (3)
C0229730 (UMLS CUI-1)
(Comment:en)
CL Item
N: infraclavicular (4)
C0229743 (UMLS CUI-1)
(Comment:en)
CL Item
N: axillar (5)
C0729594 (UMLS CUI-1)
(Comment:en)
CL Item
N: mediastinal (6)
C0588055 (UMLS CUI-1)
(Comment:en)
CL Item
N: hilar (7)
C1305372 (UMLS CUI-1)
(Comment:en)
CL Item
N: porta hepatic (8)
C0229769 (UMLS CUI-1)
(Comment:en)
CL Item
N: retroperitoneal (9)
C0229802 (UMLS CUI-1)
(Comment:en)
CL Item
N: retrocrural (10)
C2953130 (UMLS CUI-1)
(Comment:en)
CL Item
N: paraaortic (11)
CL Item
N: mesenteric (12)
CL Item
N: iliac (13)
CL Item
N: inguinal/femoral (14)
CL Item
O: tonsils (15)
CL Item
O: thymus (16)
CL Item
O: lung (17)
CL Item
O: liver (18)
CL Item
O: spleen (19)
CL Item
O: digestive tract (20)
CL Item
O: bone marrow (21)
CL Item
Other (22)
Specification
Item
Specification localisation
text
C2348235 (UMLS CUI [1])
lesion present
Item
Still present?
boolean
C0221198 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
progression lesion
Item
Progression?
boolean
C0242656 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item Group
Other lesions: New lesions
C0221198 (UMLS CUI-1)
C0205314 (UMLS CUI-2)
new lesions
Item
Have any new lesions been identified?
boolean
C2986548 (UMLS CUI [1])
Item Group
Other lesions: Localisation of new lesions
C0221198 (UMLS CUI-1)
C0205314 (UMLS CUI-2)
Item
Localisation
integer
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1518389 (UMLS CUI [1,3])
Localisation target lesion
Code List
Localisation
CL Item
N: Waldeyer Ring (1)
C0459892 (UMLS CUI-1)
C0806692 (UMLS CUI-2)
(Comment:en)
CL Item
N: cervical (2)
C0588054 (UMLS CUI-1)
(Comment:en)
CL Item
N: supraclavicular (3)
C0229730 (UMLS CUI-1)
(Comment:en)
CL Item
N: infraclavicular (4)
C0229743 (UMLS CUI-1)
(Comment:en)
CL Item
N: axillar (5)
C0729594 (UMLS CUI-1)
(Comment:en)
CL Item
N: mediastinal (6)
C0588055 (UMLS CUI-1)
(Comment:en)
CL Item
N: hilar (7)
C1305372 (UMLS CUI-1)
(Comment:en)
CL Item
N: porta hepatic (8)
C0229769 (UMLS CUI-1)
(Comment:en)
CL Item
N: retroperitoneal (9)
C0229802 (UMLS CUI-1)
(Comment:en)
CL Item
N: retrocrural (10)
C2953130 (UMLS CUI-1)
(Comment:en)
CL Item
N: paraaortic (11)
CL Item
N: mesenteric (12)
CL Item
N: iliac (13)
CL Item
N: inguinal/femoral (14)
CL Item
O: tonsils (15)
CL Item
O: thymus (16)
CL Item
O: lung (17)
CL Item
O: liver (18)
CL Item
O: spleen (19)
CL Item
O: digestive tract (20)
CL Item
O: bone marrow (21)
CL Item
Other (22)
specification
Item
If necessary, specify localisation:
text
C2348235 (UMLS CUI [1])
Item Group
Tumor Assessment
C3889740 (UMLS CUI-1)
Complete Response
Item
CR
boolean
C0677874 (UMLS CUI [1])
complete remission unconfirmed
Item
CRu
boolean
C0677874 (UMLS CUI [1,1])
C1547326 (UMLS CUI [1,2])
Partial Response
Item
PR
boolean
C1521726 (UMLS CUI [1])
tumor assessment SD
Item
SD
boolean
C0677946 (UMLS CUI [1])
Progressive Disease
Item
PD
boolean
C1335499 (UMLS CUI [1])
Unknown
Item
Unknown
boolean
C0439673 (UMLS CUI [1])
Tumor biopsy
Item
EoT: In case of PR or less: Tumor biopsy performed?
boolean
C0677862 (UMLS CUI [1])
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