ID

27966

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

December 7, 2017

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

Subject ID
Description

Subject ID

Data type

text

Visit
Description

Visit

Data type

text

Staging
Description

Staging

Staging date
Description

Staging date

Data type

date

Method
Description

Method

Data type

text

If applicable: Reason for not using contrast agent
Description

Reason for not using contrast agent

Data type

text

PET Scan performed?
Description

PET Scan performed

Data type

boolean

If "yes": PET Scan is
Description

PET scan result

Data type

text

If PET Scan is positive: please specify
Description

PET scan result specification

Data type

text

Target Lesions
Description

Target Lesions

No.
Description

Target lesion number

Data type

integer

Localisation
Description

N = Node, O = Organ

Data type

integer

Specification localisation
Description

specification localisation

Data type

text

Side
Description

Side target lesion

Data type

text

Measurable?
Description

Measurable target lesion

Data type

text

Size
Description

Size target lesion

Data type

integer

Measurement units
  • mm
mm
Size
Description

Size target lesion

Data type

integer

Measurement units
  • mm
mm
Target lesions: Sum of sizes
Description

Target lesions: Sum of sizes

Sum
Description

sum target lesion sizes

Data type

integer

Measurement units
  • mm2
mm2
Other lesions: Pre-existing non-target lesions
Description

Other lesions: Pre-existing non-target lesions

No.
Description

lesion number

Data type

integer

Localisation
Description

N = Node, O = Organ

Data type

integer

Specification localisation
Description

Specification lesion localisation

Data type

text

Still present?
Description

lesion still present

Data type

boolean

Progression?
Description

lesion progression

Data type

boolean

Other lesions: New lesions
Description

Other lesions: New lesions

Have any new lesions been identified?
Description

new lesions

Data type

boolean

Other lesions: Localisation of new lesions
Description

Other lesions: Localisation of new lesions

Localisation
Description

N=Node, O=Organ

Data type

integer

If necessary, specify localisation:
Description

specification localisation new lesion

Data type

text

Tumor Assessment
Description

Tumor Assessment

CR
Description

tumor assessment CR

Data type

boolean

CRu
Description

tumor assessment CRu

Data type

boolean

PR
Description

tumor assessment PR

Data type

boolean

SD
Description

tumor assessment SD

Data type

boolean

PD
Description

tumor assessment PD

Data type

boolean

Unknown
Description

tumor assessment Unknown

Data type

boolean

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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
Subject ID
Item
Subject ID
text
Item
Visit
text
Visit
Code List
Visit
CL Item
Interim Staging (Interim Staging)
CL Item
End of Treatment (End of Treatment)
CL Item
Follow Up 2 (Follow Up 2)
CL Item
Follow Up 4 (Follow Up 4)
CL Item
Follow Up 6 (Follow Up 6)
CL Item
Follow Up 8 (Follow Up 8)
Item Group
Staging
Staging date
Item
Staging date
date
Item
Method
text
Method
Code List
Method
CL Item
Contrast CT (Contrast CT)
CL Item
Non-contrast CT (Non-contrast CT)
CL Item
MRI (MRI)
CL Item
Not done (Not done)
Reason for not using contrast agent
Item
If applicable: Reason for not using contrast agent
text
PET Scan performed
Item
PET Scan performed?
boolean
Item
If "yes": PET Scan is
text
PET scan result
Code List
If "yes": PET Scan is
CL Item
Positive (Positive)
CL Item
Negative (Negative)
PET scan result specification
Item
If PET Scan is positive: please specify
text
Item Group
Target Lesions
Item
No.
integer
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
Localisation target lesion
Code List
Localisation
CL Item
N: Waldeyer Ring (1)
CL Item
N: cervical (2)
CL Item
N: supraclavicular (3)
CL Item
N: infraclavicular (4)
CL Item
N: axillar (5)
CL Item
N: mediastinal (6)
CL Item
N: hilar (7)
CL Item
N: porta hepatic (8)
CL Item
N: retroperitoneal (9)
CL Item
N: retrocrural (10)
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 localisation
Item
Specification localisation
text
Item
Side
text
Side target lesion
Code List
Side
CL Item
Left (Left)
CL Item
Right (Right)
CL Item
N.a. (N.a.)
Item
Measurable?
text
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
Size target lesion
Item
Size
integer
Item Group
Target lesions: Sum of sizes
sum target lesion sizes
Item
Sum
integer
Item Group
Other lesions: Pre-existing non-target lesions
Item
No.
integer
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)
CL Item
N: cervical (2)
CL Item
N: supraclavicular (3)
CL Item
N: infraclavicular (4)
CL Item
N: axillar (5)
CL Item
N: mediastinal (6)
CL Item
N: hilar (7)
CL Item
N: porta hepatic (8)
CL Item
N: retroperitoneal (9)
CL Item
N: retrocrural (10)
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 lesion localisation
Item
Specification localisation
text
lesion still present
Item
Still present?
boolean
lesion progression
Item
Progression?
boolean
Item Group
Other lesions: New lesions
new lesions
Item
Have any new lesions been identified?
boolean
Item Group
Other lesions: Localisation of new lesions
Item
Localisation
integer
Localisation target lesion
Code List
Localisation
CL Item
N: Waldeyer Ring (1)
CL Item
N: cervical (2)
CL Item
N: supraclavicular (3)
CL Item
N: infraclavicular (4)
CL Item
N: axillar (5)
CL Item
N: mediastinal (6)
CL Item
N: hilar (7)
CL Item
N: porta hepatic (8)
CL Item
N: retroperitoneal (9)
CL Item
N: retrocrural (10)
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 localisation new lesion
Item
If necessary, specify localisation:
text
Item Group
Tumor Assessment
tumor assessment CR
Item
CR
boolean
tumor assessment CRu
Item
CRu
boolean
tumor assessment PR
Item
PR
boolean
tumor assessment SD
Item
SD
boolean
tumor assessment PD
Item
PD
boolean
tumor assessment Unknown
Item
Unknown
boolean
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