ID

5060

Beschreibung

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

Link

http://clinicaltrials.gov/show/NCT00983138

Stichworte

Versionen (2)
  1. 07.12.13 07.12.13 - Martin Dugas
  2. 17.04.14 17.04.14 - Julian Varghese
Hochgeladen am

17. April 2014

DOI

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Creative Commons BY 4.0
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    Eligibility DRKS00003784 NCT00983138 Acute Lymphoid Leukemia

    Deutsch Englisch

    Eligibility

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beschreibung

    Einschlusskriterien

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

    age up to 364 Days

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    boolean

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

    Treatment according to protocol INTERFANT 06

    Datentyp

    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
    Beschreibung

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    Known allergy to any ASNase preparation.

    Datentyp

    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).
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    Pre-existing pancreatitis.

    Datentyp

    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).
    Beschreibung

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

    Datentyp

    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
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
    Zum Seitenanfang zurückkehren 

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