ID

5341

Description

Prospective non–randomized multi​center study for epidemiology and characterization of Myelodysplastic Syndromes(MDS) and Juvenile Myelomonocytic Leukemia (JMML) in child­hood. PI: Prof. Dr. Charlotte Niemeyer http://clinicaltrials.gov/ct2/show/NCT00662090 http://www.ewog-mds.org/

Link

http://clinicaltrials.gov/ct2/show/NCT00662090

Keywords

  1. 8/5/14 8/5/14 - Martin Dugas
Uploaded on

August 5, 2014

DOI

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License

Creative Commons BY 4.0

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EWOG MDS 2006 Status at HSCT DRKS00003789

Status at HSCT

  1. StudyEvent: SE
    1. Status at HSCT
Show identification of patient
Description

Show identification of patient

Dummy
Description

Dummy

Data type

text

Body measurements
Description

Body measurements

Body height
Description

Body height

Data type

integer

Measurement units
  • cm
cm
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
kg
Body surface area (BSA)
Description

Body surface area (BSA)

Data type

float

Measurement units
BSA calculated
Description

BSA calculated

Data type

float

Measurement units
Performance status (Karnofsky/Lansky)
Description

Performance status (Karnofsky/Lansky)

Date of assessment
Description

Date of assessment

Data type

date

Score Karnofsky/Lansky
Description

Score Karnofsky/Lansky

Data type

integer

Clinical data at HSCT (MDS specific)
Description

Clinical data at HSCT (MDS specific)

Splenomegaly
Description

Splenomegaly

Data type

integer

Spleen size below costal margin (in cm)
Description

Spleen size below costal margin by palpation (in cm)

Data type

integer

Measurement units
  • cm
cm
Splenic irradiation
Description

Splenic irradiation

Data type

integer

Splenic irradiation dose
Description

Splenic irradiation dose

Data type

integer

Measurement units
  • Gy
Gy
Splenectomy before HSCT
Description

Splenectomy before HSCT

Data type

integer

Hepatomegaly
Description

Hepatomegaly

Data type

integer

Liver size below costal margin by palpation (in cm)
Description

Liver size below costal margin by palpation (in cm)

Data type

integer

Measurement units
  • cm
cm
Lymph node > 1.5cm
Description

Lymph node > 1.5cm

Data type

integer

Interstitial pneumonitis
Description

Interstitial pneumonitis

Data type

integer

Effusion
Description

Effusion

Data type

integer

Effusion pleural
Description

Effusion pleural

Data type

integer

Effusion pericardial
Description

Effusion pericardial

Data type

integer

Effusion ascites
Description

Effusion ascites

Data type

integer

Effusion other
Description

Effusion other

Data type

integer

Other effusion text
Description

Other effusion text

Data type

text

Joint pain/arthritis
Description

Joint pain/arthritis

Data type

integer

Skin lesion (other than naevi, hematoma)
Description

Skin lesion (other than naevi, hematoma)

Data type

integer

Xanthoma
Description

Xanthoma

Data type

integer

Café-au-lait spots
Description

Café-au-lait spots

Data type

integer

Number of café-au-lait spots
Description

Number of cafe au lait spots

Data type

integer

Size of biggest spot
Description

Size of biggest spot

Data type

integer

Measurement units
  • cm
cm
NF1
Description

NF1

Data type

integer

CSF cytology (MDS specific)
Description

CSF cytology (MDS specific)

CSF visibly contaminated with blood
Description

CSF visibly contaminated with blood

Data type

integer

Date of evaluation
Description

Date of evaluation

Data type

date

Erythrocytes in CSF
Description

Erythrocytes in CSF

Data type

integer

Measurement units
  • /µl
/µl
Leucocytes in CSF
Description

Leucocytes in CSF

Data type

integer

Measurement units
  • /µl
/µl
Total blasts in cyto spin slide
Description

Total blasts in cyto spin slide

Data type

integer

BM/PB blasts (MDS specific)
Description

BM/PB blasts (MDS specific)

BM blasts (closest to the start of cond reg.)
Description

BM blasts (closest to the start of cond reg.)

Data type

integer

Measurement units
  • %
%
Date of BM aspirate
Description

Date of BM aspirate

Data type

date

PB blasts (closest to the start of cond reg.)
Description

PB blasts (closest to the start of cond reg.)

Data type

integer

Measurement units
  • %
%
Date of PB
Description

Date of PB

Data type

date

WBC
Description

WBC

Data type

float

Measurement units
  • x 10³ / µl
x 10³ / µl
Disease status at HSCT
Description

Disease status at HSCT

Disease status at HSCT
Description

Disease status at HSCT

Data type

integer

Chronolog. no. of this CR
Description

Chronolog. no. of this CR

Data type

integer

Chronolog. no. of this PR
Description

Chronolog. no. of this PR

Data type

integer

Secondary malignancy
Description

Secondary malignancy

Data type

integer

SC specific data
Description

SC specific data

Overall kary-code 1
Description

Overall kary code 1

Data type

integer

Overall kary-code 2
Description

Overall kary-code 2

Data type

integer

MDS diagnosis
Description

MDS diagnosis

Data type

integer

Similar models

Status at HSCT

  1. StudyEvent: SE
    1. Status at HSCT
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy
Item
Dummy
text
Body height
Item
Body height
integer
Body weight
Item
Body weight
float
Body surface area (BSA)
Item
Body surface area (BSA)
float
BSA calculated
Item
BSA calculated
float
Date of assessment
Item
Date of assessment
date
Item
Score Karnofsky/Lansky
integer
Code List
Score Karnofsky/Lansky
CL Item
100% (100)
CL Item
90% (90)
CL Item
80% (80)
CL Item
70% (70)
CL Item
60% (60)
CL Item
50% (50)
CL Item
40% (40)
CL Item
30% (30)
CL Item
20% (20)
CL Item
10% (10)
Item
Splenomegaly
integer
Code List
Splenomegaly
CL Item
No (1)
CL Item
Yes (2)
Spleen size below costal margin by palpation (in cm)
Item
Spleen size below costal margin (in cm)
integer
Item
Splenic irradiation
integer
Code List
Splenic irradiation
CL Item
No (1)
CL Item
Yes (2)
Splenic irradiation dose
Item
Splenic irradiation dose
integer
Item
Splenectomy before HSCT
integer
Code List
Splenectomy before HSCT
CL Item
No (1)
CL Item
Yes (2)
Item
Hepatomegaly
integer
Code List
Hepatomegaly
CL Item
No (1)
CL Item
Yes (2)
Liver size below costal margin by palpation (in cm)
Item
Liver size below costal margin by palpation (in cm)
integer
Item
Lymph node > 1.5cm
integer
Code List
Lymph node > 1.5cm
CL Item
No (1)
CL Item
Yes (2)
Item
Interstitial pneumonitis
integer
Code List
Interstitial pneumonitis
CL Item
No (1)
CL Item
Yes (2)
Item
Effusion
integer
Code List
Effusion
CL Item
No (1)
CL Item
Yes (2)
Item
Effusion pleural
integer
Code List
Effusion pleural
CL Item
No (1)
CL Item
Yes (2)
Item
Effusion pericardial
integer
Code List
Effusion pericardial
CL Item
No (1)
CL Item
Yes (2)
Item
Effusion ascites
integer
Code List
Effusion ascites
CL Item
No (1)
CL Item
Yes (2)
Item
Effusion other
integer
Code List
Effusion other
CL Item
No (1)
CL Item
Yes (2)
Other effusion text
Item
Other effusion text
text
Item
Joint pain/arthritis
integer
Code List
Joint pain/arthritis
CL Item
No (1)
CL Item
Yes (2)
Item
Skin lesion (other than naevi, hematoma)
integer
Code List
Skin lesion (other than naevi, hematoma)
CL Item
No (1)
CL Item
Yes (2)
Item
Xanthoma
integer
Code List
Xanthoma
CL Item
No (1)
CL Item
Yes (2)
Item
Café-au-lait spots
integer
Code List
Café-au-lait spots
CL Item
No (1)
CL Item
Yes (2)
Item
Number of café-au-lait spots
integer
Code List
Number of café-au-lait spots
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
>=10 (10)
Size of biggest spot
Item
Size of biggest spot
integer
Item
NF1
integer
Code List
NF1
CL Item
No (1)
CL Item
Yes (2)
Item
CSF visibly contaminated with blood
integer
Code List
CSF visibly contaminated with blood
CL Item
No (1)
CL Item
Yes (2)
Date of evaluation
Item
Date of evaluation
date
Erythrocytes in CSF
Item
Erythrocytes in CSF
integer
Leucocytes in CSF
Item
Leucocytes in CSF
integer
Total blasts in cyto spin slide
Item
Total blasts in cyto spin slide
integer
BM blasts (closest to the start of cond reg.)
Item
BM blasts (closest to the start of cond reg.)
integer
Date of BM aspirate
Item
Date of BM aspirate
date
PB blasts (closest to the start of cond reg.)
Item
PB blasts (closest to the start of cond reg.)
integer
Date of PB
Item
Date of PB
date
WBC
Item
WBC
float
Item
Disease status at HSCT
integer
Code List
Disease status at HSCT
CL Item
Complete remission (CR) (1)
CL Item
Partial remission (PR) (2)
CL Item
Refractory disease / Primary induction failure / never in remission (3)
CL Item
Relapse/Progression (4)
CL Item
Untreated (Upfront) (5)
Chronolog. no. of this CR
Item
Chronolog. no. of this CR
integer
Chronolog. no. of this PR
Item
Chronolog. no. of this PR
integer
Item
Secondary malignancy
integer
Code List
Secondary malignancy
CL Item
No (1)
CL Item
Yes (2)
Item
Overall kary-code 1
integer
Code List
Overall kary-code 1
CL Item
No result (0)
CL Item
Normal by metaphase cytogenetics (1)
CL Item
-7 alone (51)
CL Item
-7 +add (52)
CL Item
7q- alone (53)
CL Item
7q- +add (54)
CL Item
-7 unclear (55)
CL Item
+8 alone (57)
CL Item
+8 +add (58)
CL Item
Random aberration (99)
CL Item
Normal for 7+8 by FISH (40)
CL Item
-7 by FISH (41)
CL Item
+8 by FISH (42)
CL Item
Other abn by FISH (43)
Item
Overall kary-code 2
integer
Code List
Overall kary-code 2
CL Item
complex 3 or 4 aberrations (35)
CL Item
complex>4 aberrations (36)
CL Item
EWOG complex (37)
Item
MDS diagnosis
integer
Code List
MDS diagnosis
CL Item
RC (41)
CL Item
RARS (42)
CL Item
RAEB (43)
CL Item
RAEB-T (44)
CL Item
MDR-AML (40)
CL Item
JMML (45)
CL Item
CMML (46)
CL Item
Noonan Syn. + JMML like picture (47)
CL Item
Hypereosinophilic syndrome (50)
CL Item
Myelofibrotic MDS (60)
CL Item
MDS, unclassified (99)

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