ID

5060

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00983138

Länk

http://clinicaltrials.gov/show/NCT00983138

Nyckelord

Versioner (2)
  1. 2013-12-07 2013-12-07 - Martin Dugas
  2. 2014-04-17 2014-04-17 - Julian Varghese
Uppladdad den

17 april 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility DRKS00003784 NCT00983138 Acute Lymphoid Leukemia

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter bis zu 364 Tage
Beskrivning

age up to 364 Days

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
Beskrivning

Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
Morphological verification of the diagnosis, confirmed with cyto-chemistry and immunophenotyping.
Beskrivning

Morphological verification of the diagnosis, confirmed with cyto-chemistry and immunophenotyping.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332437
SNOMED CT 2011_0131
116676008
LOINC Version 232
MTHU008051
UMLS CUI 2011AA
C1711411
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0010741
UMLS CUI 2011AA
C0079611
SNOMED CT 2011_0131
414466002
MedDRA 14.1
10071534
Written informed consent of the parents or other legally authorised guardian of the patient.
Beskrivning

Written informed consent of the parents or other legally authorised guardian of the patient.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Treatment according to protocol INTERFANT 06
Beskrivning

Treatment according to protocol INTERFANT 06

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0442711
SNOMED CT 2011_0131
258049002
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
Beskrivning

Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0023435
SNOMED CT 2011_0131
22197008
MedDRA 14.1
10003917
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0456570
SNOMED CT 2011_0131
277251009
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0034789
SNOMED CT 2011_0131
66875007
UMLS CUI 2011AA
C0040715
SNOMED CT 2011_0131
15897004
UMLS CUI 2011AA
C2717920
UMLS CUI 2011AA
C1883713
UMLS CUI 2011AA
C1292769
SNOMED CT 2011_0131
128823009
MedDRA 14.1
10003890
The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
Beskrivning

The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C1515809
UMLS CUI 2011AA
C0004891
SNOMED CT 2011_0131
56564003
LOINC Version 232
MTHU021298
UMLS CUI 2011AA
C1517806
Systemic use of corticosteroids < 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
Beskrivning

Systemic use of corticosteroids < 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Known allergy to any ASNase preparation.
Beskrivning

Known allergy to any ASNase preparation.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0003993
SNOMED CT 2011_0131
371014004
UMLS CUI 2011AA
C0013227
Pre-existing known coagulopathy (e.g. haemophilia).
Beskrivning

Pre-existing known coagulopathy (e.g. haemophilia).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
UMLS CUI 2011AA
C0684275
SNOMED CT 2011_0131
90935002
MedDRA 14.1
10061992
Pre-existing pancreatitis.
Beskrivning

Pre-existing pancreatitis.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0030305
SNOMED CT 2011_0131
75694006
MedDRA 14.1
10033645
ICD-10-CM Version 2010
K85.9
ICD-9-CM Version 2011
577.0
CTCAE 1105E
E10930
Liver insufficiency (bilirubin > 50 micromol/L, SGOT/SGPT > 10 x the upper limit of normal).
Beskrivning

Liver insufficiency (bilirubin > 50 micromol/L, SGOT/SGPT > 10 x the upper limit of normal).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1306571
SNOMED CT 2011_0131
59927004
MedDRA 14.1
10056542
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
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Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age up to 364 Days
Item
Alter bis zu 364 Tage
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
Item
Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
Morphological verification of the diagnosis, confirmed with cyto-chemistry and immunophenotyping.
Item
Morphological verification of the diagnosis, confirmed with cyto-chemistry and immunophenotyping.
boolean
C0332437 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C1711411 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0750484 (UMLS CUI 2011AA)
C0010741 (UMLS CUI 2011AA)
C0079611 (UMLS CUI 2011AA)
414466002 (SNOMED CT 2011_0131)
10071534 (MedDRA 14.1)
Written informed consent of the parents or other legally authorised guardian of the patient.
Item
Written informed consent of the parents or other legally authorised guardian of the patient.
boolean
C0021430 (UMLS CUI 2011AA)
Treatment according to protocol INTERFANT 06
Item
Treatment according to protocol INTERFANT 06
boolean
C0039798 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0442711 (UMLS CUI 2011AA)
258049002 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
Item
Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
boolean
C0023435 (UMLS CUI 2011AA)
22197008 (SNOMED CT 2011_0131)
10003917 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0456570 (UMLS CUI 2011AA)
277251009 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0034789 (UMLS CUI 2011AA)
66875007 (SNOMED CT 2011_0131)
C0040715 (UMLS CUI 2011AA)
15897004 (SNOMED CT 2011_0131)
C2717920 (UMLS CUI 2011AA)
C1883713 (UMLS CUI 2011AA)
C1292769 (UMLS CUI 2011AA)
128823009 (SNOMED CT 2011_0131)
10003890 (MedDRA 14.1)
The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
Item
The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C1515809 (UMLS CUI 2011AA)
C0004891 (UMLS CUI 2011AA)
56564003 (SNOMED CT 2011_0131)
MTHU021298 (LOINC Version 232)
C1517806 (UMLS CUI 2011AA)
Systemic use of corticosteroids < 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
Item
Systemic use of corticosteroids < 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Known allergy to any ASNase preparation.
Item
Known allergy to any ASNase preparation.
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0003993 (UMLS CUI 2011AA)
371014004 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
Pre-existing known coagulopathy (e.g. haemophilia).
Item
Pre-existing known coagulopathy (e.g. haemophilia).
boolean
C2347662 (UMLS CUI 2011AA)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
C0684275 (UMLS CUI 2011AA)
90935002 (SNOMED CT 2011_0131)
10061992 (MedDRA 14.1)
Pre-existing pancreatitis.
Item
Pre-existing pancreatitis.
boolean
C2347662 (UMLS CUI 2011AA)
C0030305 (UMLS CUI 2011AA)
75694006 (SNOMED CT 2011_0131)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)
Liver insufficiency (bilirubin > 50 micromol/L, SGOT/SGPT > 10 x the upper limit of normal).
Item
Liver insufficiency (bilirubin > 50 micromol/L, SGOT/SGPT > 10 x the upper limit of normal).
boolean
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
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