ID

5062

Description

ODM derived from http://clinicaltrials.gov/show/NCT00987636

Link

http://clinicaltrials.gov/show/NCT00987636

Keywords

  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility NCT00987636 Ewing's Sarcoma

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age 48 Months to 50 Years
    Description

    age 48 Months to 50 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
    Description

    Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0585474
    SNOMED CT 2011_0131
    307608006
    UMLS CUI 2011AA
    CL432298
    SNOMED CT 2011_0131
    447951009
    Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
    Description

    Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1706086
    UMLS CUI 2011AA
    C0079399
    SNOMED CT 2011_0131
    263495000
    LOINC Version 232
    MTHU002975
    UMLS CUI 2011AA
    C0037459
    UMLS CUI 2011AA
    C1518931
    SNOMED CT 2011_0131
    418002000
    UMLS CUI 2011AA
    C1690538
    SNOMED CT 2011_0131
    418652005
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    UMLS CUI 2011AA
    CL415042
    UMLS CUI 2011AA
    C0005558
    SNOMED CT 2011_0131
    86273004
    MedDRA 14.1
    10004720
    LOINC Version 232
    MTHU028106
    Registration: <= 45 days after diagnostic biopsy/surgery.
    Description

    Registration: <= 45 days after diagnostic biopsy/surgery.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1516879
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    CL415042
    UMLS CUI 2011AA
    C0005558
    SNOMED CT 2011_0131
    86273004
    MedDRA 14.1
    10004720
    LOINC Version 232
    MTHU028106
    UMLS CUI 2011AA
    C0038895
    Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.
    Description

    Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL414705
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    CL415042
    UMLS CUI 2011AA
    C0005558
    SNOMED CT 2011_0131
    86273004
    MedDRA 14.1
    10004720
    LOINC Version 232
    MTHU028106
    UMLS CUI 2011AA
    C0038895
    Informed consent: Must be signed prior to study entry.
    Description

    Informed consent: Must be signed prior to study entry.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.
    Description

    Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1522275
    UMLS CUI 2011AA
    C0206065
    SNOMED CT 2011_0131
    273546003
    UMLS CUI 2011AA
    C0598558
    Haematological parameters:
    Description

    Haematological parameters:

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205488
    SNOMED CT 2011_0131
    57407000
    UMLS CUI 2011AA
    C0449381
    SNOMED CT 2011_0131
    252116004
    Haemoglobin > 8 g/dl (transfusion allowed),
    Description

    Haemoglobin > 8 g/dl (transfusion allowed),

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0019046
    SNOMED CT 2011_0131
    38082009
    MedDRA 14.1
    10019481
    LOINC Version 232
    LP14449-0
    UMLS CUI 2011AA
    C1879316
    SNOMED CT 2011_0131
    5447007
    MedDRA 14.1
    10066152
    UMLS CUI 2011AA
    C0521104
    SNOMED CT 2011_0131
    75554001
    Platelets > 80.000/nicrol (transfusion allowed),
    Description

    Platelets > 80.000/nicrol (transfusion allowed),

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0005821
    SNOMED CT 2011_0131
    16378004
    LOINC Version 232
    MTHU002432
    UMLS CUI 2011AA
    C1879316
    SNOMED CT 2011_0131
    5447007
    MedDRA 14.1
    10066152
    UMLS CUI 2011AA
    C0521104
    SNOMED CT 2011_0131
    75554001
    Leukocyte, WBC - White blood cell
    Description

    WBC > 2000/nicrol.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023516
    SNOMED CT 2011_0131
    52501007
    MedDRA 14.1
    10047955
    LOINC Version 232
    MTHU001946
    Cardiac values: LVEF > 40%, SF > 28%.
    Description

    Cardiac values: LVEF > 40%, SF > 28%.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1522601
    UMLS CUI 2011AA
    C1522609
    UMLS CUI 2011AA
    C0428772
    SNOMED CT 2011_0131
    250908004
    MedDRA 14.1
    10069170
    UMLS CUI 2011AA
    C1335957
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    > one cycle of other chemotherapy prior to registration
    Description

    > one cycle of other chemotherapy prior to registration

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0439093
    SNOMED CT 2011_0131
    276140008
    HL7 V3 2006_05
    GT
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C1302181
    SNOMED CT 2011_0131
    399042005
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1516879
    Neoplasms, Second Primary
    Description

    Second malignancy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0085183
    Pregnancy and lactation
    Description

    Pregnancy and lactation

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
    Description

    Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C2349179
    UMLS CUI 2011AA
    C0003297
    SNOMED CT 2011_0131
    52017007
    UMLS CUI 2011AA
    C0003308
    SNOMED CT 2011_0131
    373219008
    UMLS CUI 2011AA
    C0003232
    SNOMED CT 2011_0131
    255631004
    UMLS CUI 2011AA
    CL025471
    UMLS CUI 2011AA
    C1521721
    Any other medical, psychiatric, or social condition incompatible with protocol treatment
    Description

    Any other medical, psychiatric, or social condition incompatible with protocol treatment

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700
    HL7 V3 2006_05
    MEDCCAT
    UMLS CUI 2011AA
    C0809986
    UMLS CUI 2011AA
    C0037403
    SNOMED CT 2011_0131
    82996008
    UMLS CUI 2011AA
    C0679426
    UMLS CUI 2011AA
    C2348563
    UMLS CUI 2011AA
    C0039798

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age 48 Months to 50 Years
    Item
    age 48 Months to 50 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
    Item
    Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    C0585474 (UMLS CUI 2011AA)
    307608006 (SNOMED CT 2011_0131)
    CL432298 (UMLS CUI 2011AA)
    447951009 (SNOMED CT 2011_0131)
    Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
    Item
    Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
    boolean
    C1706086 (UMLS CUI 2011AA)
    C0079399 (UMLS CUI 2011AA)
    263495000 (SNOMED CT 2011_0131)
    MTHU002975 (LOINC Version 232)
    C0037459 (UMLS CUI 2011AA)
    C1518931 (UMLS CUI 2011AA)
    418002000 (SNOMED CT 2011_0131)
    C1690538 (UMLS CUI 2011AA)
    418652005 (SNOMED CT 2011_0131)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    CL415042 (UMLS CUI 2011AA)
    C0005558 (UMLS CUI 2011AA)
    86273004 (SNOMED CT 2011_0131)
    10004720 (MedDRA 14.1)
    MTHU028106 (LOINC Version 232)
    Registration: <= 45 days after diagnostic biopsy/surgery.
    Item
    Registration: <= 45 days after diagnostic biopsy/surgery.
    boolean
    C1516879 (UMLS CUI 2011AA)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    CL415042 (UMLS CUI 2011AA)
    C0005558 (UMLS CUI 2011AA)
    86273004 (SNOMED CT 2011_0131)
    10004720 (MedDRA 14.1)
    MTHU028106 (LOINC Version 232)
    C0038895 (UMLS CUI 2011AA)
    Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.
    Item
    Start of chemotherapy: <= 45 days after diagnostic biopsy/surgery.
    boolean
    CL414705 (UMLS CUI 2011AA)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    CL415042 (UMLS CUI 2011AA)
    C0005558 (UMLS CUI 2011AA)
    86273004 (SNOMED CT 2011_0131)
    10004720 (MedDRA 14.1)
    MTHU028106 (LOINC Version 232)
    C0038895 (UMLS CUI 2011AA)
    Informed consent: Must be signed prior to study entry.
    Item
    Informed consent: Must be signed prior to study entry.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.
    Item
    Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.
    boolean
    C1522275 (UMLS CUI 2011AA)
    C0206065 (UMLS CUI 2011AA)
    273546003 (SNOMED CT 2011_0131)
    C0598558 (UMLS CUI 2011AA)
    Haematological parameters:
    Item
    Haematological parameters:
    boolean
    C0205488 (UMLS CUI 2011AA)
    57407000 (SNOMED CT 2011_0131)
    C0449381 (UMLS CUI 2011AA)
    252116004 (SNOMED CT 2011_0131)
    Haemoglobin > 8 g/dl (transfusion allowed),
    Item
    Haemoglobin > 8 g/dl (transfusion allowed),
    boolean
    C0019046 (UMLS CUI 2011AA)
    38082009 (SNOMED CT 2011_0131)
    10019481 (MedDRA 14.1)
    LP14449-0 (LOINC Version 232)
    C1879316 (UMLS CUI 2011AA)
    5447007 (SNOMED CT 2011_0131)
    10066152 (MedDRA 14.1)
    C0521104 (UMLS CUI 2011AA)
    75554001 (SNOMED CT 2011_0131)
    Platelets > 80.000/nicrol (transfusion allowed),
    Item
    Platelets > 80.000/nicrol (transfusion allowed),
    boolean
    C0005821 (UMLS CUI 2011AA)
    16378004 (SNOMED CT 2011_0131)
    MTHU002432 (LOINC Version 232)
    C1879316 (UMLS CUI 2011AA)
    5447007 (SNOMED CT 2011_0131)
    10066152 (MedDRA 14.1)
    C0521104 (UMLS CUI 2011AA)
    75554001 (SNOMED CT 2011_0131)
    WBC > 2000/nicrol.
    Item
    Leukocyte, WBC - White blood cell
    boolean
    C0023516 (UMLS CUI 2011AA)
    52501007 (SNOMED CT 2011_0131)
    10047955 (MedDRA 14.1)
    MTHU001946 (LOINC Version 232)
    Cardiac values: LVEF > 40%, SF > 28%.
    Item
    Cardiac values: LVEF > 40%, SF > 28%.
    boolean
    C1522601 (UMLS CUI 2011AA)
    C1522609 (UMLS CUI 2011AA)
    C0428772 (UMLS CUI 2011AA)
    250908004 (SNOMED CT 2011_0131)
    10069170 (MedDRA 14.1)
    C1335957 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    > one cycle of other chemotherapy prior to registration
    Item
    > one cycle of other chemotherapy prior to registration
    boolean
    C0439093 (UMLS CUI 2011AA)
    276140008 (SNOMED CT 2011_0131)
    GT (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C1302181 (UMLS CUI 2011AA)
    399042005 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1516879 (UMLS CUI 2011AA)
    Second malignancy
    Item
    Neoplasms, Second Primary
    boolean
    C0085183 (UMLS CUI 2011AA)
    Pregnancy and lactation
    Item
    Pregnancy and lactation
    boolean
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
    Item
    Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
    boolean
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C2349179 (UMLS CUI 2011AA)
    C0003297 (UMLS CUI 2011AA)
    52017007 (SNOMED CT 2011_0131)
    C0003308 (UMLS CUI 2011AA)
    373219008 (SNOMED CT 2011_0131)
    C0003232 (UMLS CUI 2011AA)
    255631004 (SNOMED CT 2011_0131)
    CL025471 (UMLS CUI 2011AA)
    C1521721 (UMLS CUI 2011AA)
    Any other medical, psychiatric, or social condition incompatible with protocol treatment
    Item
    Any other medical, psychiatric, or social condition incompatible with protocol treatment
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0809986 (UMLS CUI 2011AA)
    C0037403 (UMLS CUI 2011AA)
    82996008 (SNOMED CT 2011_0131)
    C0679426 (UMLS CUI 2011AA)
    C2348563 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial