0 Avaliações
ID

42751

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00855218

Link

http://clinicaltrials.gov/show/NCT00855218

Palavras-chave

Versões (2)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 17/09/2021 17/09/2021 -
Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility NCT00855218 Carcinoma, Hepatocellular

    Alemão Inglês

    Eligibility

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrição

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Descrição

    age at least 18 Years

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
    Descrição

    Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0205416
    SNOMED CT 2011_0131
    56152004
    UMLS CUI 2011AA
    C0231221
    SNOMED CT 2011_0131
    84387000
    UMLS CUI 2011AA
    C1336869
    UMLS CUI 2011AA
    C1264755
    SNOMED CT 2011_0131
    127494000
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C1517058
    UMLS CUI 2011AA
    C0332261
    SNOMED CT 2011_0131
    410677005, 410676001
    Confirmed Diagnosis of HCC:
    Descrição

    Confirmed Diagnosis of HCC:

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C2239176
    MedDRA 14.1
    10049010
    Cirrhotic subjects: Clinical diagnosis by AASLD criteria
    Descrição

    Cirrhotic subjects: Clinical diagnosis by AASLD criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0439686
    SNOMED CT 2011_0131
    255417007
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0332140
    SNOMED CT 2011_0131
    39154008
    UMLS CUI 2011AA
    C0596070
    UMLS CUI 2011AA
    C0037459
    UMLS CUI 2011AA
    C0947630
    LOINC Version 232
    MTHU008392
    UMLS CUI 2011AA
    C0023895
    SNOMED CT 2011_0131
    235856003
    MedDRA 14.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    UMLS CUI 2011AA
    CL414621
    HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
    Descrição

    HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C2239176
    MedDRA 14.1
    10049010
    UMLS CUI 2011AA
    C0439686
    SNOMED CT 2011_0131
    255417007
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C0079595
    SNOMED CT 2011_0131
    278395004
    MedDRA 14.1
    10068979
    UMLS CUI 2011AA
    C0040405
    MedDRA 14.1
    10011603
    UMLS CUI 2011AA
    C0024485
    SNOMED CT 2011_0131
    113091000
    MedDRA 14.1
    10028049
    UMLS CUI 2011AA
    C0041618
    SNOMED CT 2011_0131
    16310003
    MedDRA 14.1
    10065594
    LOINC Version 232
    MTHU000076
    HL7 V3 2006_05
    12
    UMLS CUI 2011AA
    C0493823
    SNOMED CT 2011_0131
    356442006
    Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
    Descrição

    Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0085172
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0750557
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C2919401
    SNOMED CT 2011_0131
    444734003
    Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
    Descrição

    Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0205471
    SNOMED CT 2011_0131
    40413002
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0750557
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0023890
    SNOMED CT 2011_0131
    19943007
    MedDRA 14.1
    10019641
    ICD-10-CM Version 2010
    K74.60
    Documentation of original biopsy for diagnosis is acceptable
    Descrição

    Documentation of original biopsy for diagnosis is acceptable

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0920316
    UMLS CUI 2011AA
    C0205313
    SNOMED CT 2011_0131
    19535007
    UMLS CUI 2011AA
    C0005558
    SNOMED CT 2011_0131
    86273004
    MedDRA 14.1
    10004720
    LOINC Version 232
    MTHU028106
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C1879533
    Child Pugh class A without ascites
    Descrição

    Child Pugh class A without ascites

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C4050412
    UMLS CUI 2011AA
    C0456387
    SNOMED CT 2011_0131
    277046005
    UMLS CUI 2011AA
    C1706281
    SNOMED CT 2011_0131
    422097006
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0003962
    SNOMED CT 2011_0131
    389026000
    MedDRA 14.1
    10003445
    ICD-10-CM Version 2010
    R18
    ICD-9-CM Version 2011
    789.5
    CTCAE 1105E
    E10502
    Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
    Descrição

    Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2011AA
    C0005953
    SNOMED CT 2011_0131
    14016003
    LOINC Version 232
    MTHU016536
    UMLS CUI 2011AA
    C0542341
    SNOMED CT 2011_0131
    246464006
    UMLS CUI 2011AA
    C0232741
    SNOMED CT 2011_0131
    79036002
    UMLS CUI 2011AA
    C0232804
    SNOMED CT 2011_0131
    11953005
    UMLS CUI 2011AA
    C1516048
    UMLS CUI 2011AA
    C1880016
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0034656
    Ausschlusskriterien
    Descrição

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Patients on a liver transplantation list or with advanced liver disease as defined below:
    Descrição

    Patients on a liver transplantation list or with advanced liver disease as defined below:

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0023911
    SNOMED CT 2011_0131
    18027006
    MedDRA 14.1
    10024714
    ICD-9-CM Version 2011
    50.5
    UMLS CUI 2011AA
    C0745732
    UMLS CUI 2011AA
    C0205179
    SNOMED CT 2011_0131
    86005002
    UMLS CUI 2011AA
    C0023895
    SNOMED CT 2011_0131
    235856003
    MedDRA 14.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    Child Pugh B and C
    Descrição

    Child Pugh B and C

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C4050412
    UMLS CUI 2011AA
    C0456387
    SNOMED CT 2011_0131
    277046005
    UMLS CUI 2011AA
    C0439105
    SNOMED CT 2011_0131
    421151005
    UMLS CUI 2011AA
    C0439106
    SNOMED CT 2011_0131
    257962003
    Active gastrointestinal bleeding
    Descrição

    Active gastrointestinal bleeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0017181
    SNOMED CT 2011_0131
    74474003
    MedDRA 14.1
    10017955
    ICD-10-CM Version 2010
    K92.2
    ICD-9-CM Version 2011
    578
    Enzephalopathie
    Descrição

    Encephalopathy

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0085584
    SNOMED CT 2011_0131
    81308009
    MedDRA 14.1
    10014625
    ICD-10-CM Version 2010
    G93.40
    ICD-9-CM Version 2011
    348.30
    CTCAE 1105E
    E12652
    Aszites
    Descrição

    Ascites

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0003962
    SNOMED CT 2011_0131
    389026000
    MedDRA 14.1
    10003445
    ICD-10-CM Version 2010
    R18
    ICD-9-CM Version 2011
    789.5
    CTCAE 1105E
    E10502
    Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
    Descrição

    Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0221198
    SNOMED CT 2011_0131
    49755003
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    CL426184
    UMLS CUI 2011AA
    C0728940
    SNOMED CT 2011_0131
    65801008
    UMLS CUI 2011AA
    C2239176
    MedDRA 14.1
    10049010
    UMLS CUI 2011AA
    CL382653
    UMLS CUI 2011AA
    C1880568
    UMLS CUI 2011AA
    C0010408
    SNOMED CT 2011_0131
    281609006, 427357007
    MedDRA 14.1
    10066082
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    Similar models

    Eligibility

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
    Item
    Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
    boolean
    C0205416 (UMLS CUI 2011AA)
    56152004 (SNOMED CT 2011_0131)
    C0231221 (UMLS CUI 2011AA)
    84387000 (SNOMED CT 2011_0131)
    C1336869 (UMLS CUI 2011AA)
    C1264755 (UMLS CUI 2011AA)
    127494000 (SNOMED CT 2011_0131)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C1517058 (UMLS CUI 2011AA)
    C0332261 (UMLS CUI 2011AA)
    410677005, 410676001 (SNOMED CT 2011_0131)
    Confirmed Diagnosis of HCC:
    Item
    Confirmed Diagnosis of HCC:
    boolean
    C0750484 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C2239176 (UMLS CUI 2011AA)
    10049010 (MedDRA 14.1)
    Cirrhotic subjects: Clinical diagnosis by AASLD criteria
    Item
    Cirrhotic subjects: Clinical diagnosis by AASLD criteria
    boolean
    C0439686 (UMLS CUI 2011AA)
    255417007 (SNOMED CT 2011_0131)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C0332140 (UMLS CUI 2011AA)
    39154008 (SNOMED CT 2011_0131)
    C0596070 (UMLS CUI 2011AA)
    C0037459 (UMLS CUI 2011AA)
    C0947630 (UMLS CUI 2011AA)
    MTHU008392 (LOINC Version 232)
    C0023895 (UMLS CUI 2011AA)
    235856003 (SNOMED CT 2011_0131)
    10024670 (MedDRA 14.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    CL414621 (UMLS CUI 2011AA)
    HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
    Item
    HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
    boolean
    C2239176 (UMLS CUI 2011AA)
    10049010 (MedDRA 14.1)
    C0439686 (UMLS CUI 2011AA)
    255417007 (SNOMED CT 2011_0131)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1704788 (UMLS CUI 2011AA)
    C0079595 (UMLS CUI 2011AA)
    278395004 (SNOMED CT 2011_0131)
    10068979 (MedDRA 14.1)
    C0040405 (UMLS CUI 2011AA)
    10011603 (MedDRA 14.1)
    C0024485 (UMLS CUI 2011AA)
    113091000 (SNOMED CT 2011_0131)
    10028049 (MedDRA 14.1)
    C0041618 (UMLS CUI 2011AA)
    16310003 (SNOMED CT 2011_0131)
    10065594 (MedDRA 14.1)
    MTHU000076 (LOINC Version 232)
    12 (HL7 V3 2006_05)
    C0493823 (UMLS CUI 2011AA)
    356442006 (SNOMED CT 2011_0131)
    Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
    Item
    Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
    boolean
    C0085172 (UMLS CUI 2011AA)
    C0750484 (UMLS CUI 2011AA)
    C1514873 (UMLS CUI 2011AA)
    C0750557 (UMLS CUI 2011AA)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C2919401 (UMLS CUI 2011AA)
    444734003 (SNOMED CT 2011_0131)
    Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
    Item
    Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
    boolean
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0205471 (UMLS CUI 2011AA)
    40413002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    C1514873 (UMLS CUI 2011AA)
    C0750557 (UMLS CUI 2011AA)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0023890 (UMLS CUI 2011AA)
    19943007 (SNOMED CT 2011_0131)
    10019641 (MedDRA 14.1)
    K74.60 (ICD-10-CM Version 2010)
    Documentation of original biopsy for diagnosis is acceptable
    Item
    Documentation of original biopsy for diagnosis is acceptable
    boolean
    C0920316 (UMLS CUI 2011AA)
    C0205313 (UMLS CUI 2011AA)
    19535007 (SNOMED CT 2011_0131)
    C0005558 (UMLS CUI 2011AA)
    86273004 (SNOMED CT 2011_0131)
    10004720 (MedDRA 14.1)
    MTHU028106 (LOINC Version 232)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C1879533 (UMLS CUI 2011AA)
    Child Pugh class A without ascites
    Item
    Child Pugh class A without ascites
    boolean
    C4050412 (UMLS CUI 2011AA)
    C0456387 (UMLS CUI 2011AA)
    277046005 (SNOMED CT 2011_0131)
    C1706281 (UMLS CUI 2011AA)
    422097006 (SNOMED CT 2011_0131)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0003962 (UMLS CUI 2011AA)
    389026000 (SNOMED CT 2011_0131)
    10003445 (MedDRA 14.1)
    R18 (ICD-10-CM Version 2010)
    789.5 (ICD-9-CM Version 2011)
    E10502 (CTCAE 1105E)
    Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
    Item
    Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
    boolean
    C0205411 (UMLS CUI 2011AA)
    88323005 (SNOMED CT 2011_0131)
    C0005953 (UMLS CUI 2011AA)
    14016003 (SNOMED CT 2011_0131)
    MTHU016536 (LOINC Version 232)
    C0542341 (UMLS CUI 2011AA)
    246464006 (SNOMED CT 2011_0131)
    C0232741 (UMLS CUI 2011AA)
    79036002 (SNOMED CT 2011_0131)
    C0232804 (UMLS CUI 2011AA)
    11953005 (SNOMED CT 2011_0131)
    C1516048 (UMLS CUI 2011AA)
    C1880016 (UMLS CUI 2011AA)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Patients on a liver transplantation list or with advanced liver disease as defined below:
    Item
    Patients on a liver transplantation list or with advanced liver disease as defined below:
    boolean
    C0023911 (UMLS CUI 2011AA)
    18027006 (SNOMED CT 2011_0131)
    10024714 (MedDRA 14.1)
    50.5 (ICD-9-CM Version 2011)
    C0745732 (UMLS CUI 2011AA)
    C0205179 (UMLS CUI 2011AA)
    86005002 (SNOMED CT 2011_0131)
    C0023895 (UMLS CUI 2011AA)
    235856003 (SNOMED CT 2011_0131)
    10024670 (MedDRA 14.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    Child Pugh B and C
    Item
    Child Pugh B and C
    boolean
    C4050412 (UMLS CUI 2011AA)
    C0456387 (UMLS CUI 2011AA)
    277046005 (SNOMED CT 2011_0131)
    C0439105 (UMLS CUI 2011AA)
    421151005 (SNOMED CT 2011_0131)
    C0439106 (UMLS CUI 2011AA)
    257962003 (SNOMED CT 2011_0131)
    Active gastrointestinal bleeding
    Item
    Active gastrointestinal bleeding
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0017181 (UMLS CUI 2011AA)
    74474003 (SNOMED CT 2011_0131)
    10017955 (MedDRA 14.1)
    K92.2 (ICD-10-CM Version 2010)
    578 (ICD-9-CM Version 2011)
    Encephalopathy
    Item
    Enzephalopathie
    boolean
    C0085584 (UMLS CUI 2011AA)
    81308009 (SNOMED CT 2011_0131)
    10014625 (MedDRA 14.1)
    G93.40 (ICD-10-CM Version 2010)
    348.30 (ICD-9-CM Version 2011)
    E12652 (CTCAE 1105E)
    Ascites
    Item
    Aszites
    boolean
    C0003962 (UMLS CUI 2011AA)
    389026000 (SNOMED CT 2011_0131)
    10003445 (MedDRA 14.1)
    R18 (ICD-10-CM Version 2010)
    789.5 (ICD-9-CM Version 2011)
    E10502 (CTCAE 1105E)
    Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
    Item
    Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
    boolean
    C0221198 (UMLS CUI 2011AA)
    49755003 (SNOMED CT 2011_0131)
    C1514463 (UMLS CUI 2011AA)
    CL426184 (UMLS CUI 2011AA)
    C0728940 (UMLS CUI 2011AA)
    65801008 (SNOMED CT 2011_0131)
    C2239176 (UMLS CUI 2011AA)
    10049010 (MedDRA 14.1)
    CL382653 (UMLS CUI 2011AA)
    C1880568 (UMLS CUI 2011AA)
    C0010408 (UMLS CUI 2011AA)
    281609006, 427357007 (SNOMED CT 2011_0131)
    10066082 (MedDRA 14.1)
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