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13748

Descrizione

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01067274

collegamento

https://clinicaltrials.gov/show/NCT01067274

Keywords

versioni (1)
  1. 02/03/16 02/03/16 -
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CC BY-NC 3.0

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2 marzo 2016

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Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia NCT01067274

    Inglese

    Eligibility Acute Myeloid Leukemia NCT01067274

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. aged of 65 to 79 years
    Descrizione

    1. aged of 65 to 79 years

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"
    Descrizione

    2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C1515568 (de novo)
    UMLS CUI [2]
    C2825139 (Acute Myeloid Leukemia with Myelodysplasia-Related Changes)
    SNOMED
    445448008
    3. not previously treated for aml
    Descrizione

    3. not previously treated for aml

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C0332154 (Received therapy or drug for)
    SNOMED
    69845001
    4. signed informed consent.
    Descrizione

    4. signed informed consent.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. apl in the who classification.
    Descrizione

    1. apl in the who classification.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023487 (Acute Promyelocytic Leukemia)
    SNOMED
    110004001
    2. ph1-positive aml or prior ph1-positive disease
    Descrizione

    ID.6

    Tipo di dati

    boolean

    3. aml evolving from a prior mpn in the who 2008 classification.
    Descrizione

    3. aml evolving from a prior mpn in the who 2008 classification.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0280449 (Secondary Acute Myeloid Leukemia)
    4. prior treatment with chemotherapy or radiotherapy for another tumor
    Descrizione

    4. prior treatment with chemotherapy or radiotherapy for another tumor

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [2]
    C0279134 (Prior Radiation Therapy)
    5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
    Descrizione

    5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2]
    C0007099 (Carcinoma in Situ)
    SNOMED
    109355002
    UMLS CUI [3]
    C0699893 (Skin carcinoma)
    6. prior advanced malignant hepatic tumor
    Descrizione

    6. prior advanced malignant hepatic tumor

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0345904 (Malignant neoplasm of liver)
    SNOMED
    93870000
    7. ecog performance status score > 2
    Descrizione

    7. ecog performance status score > 2

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.
    Descrizione

    8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.
    Descrizione

    9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    10. ast (sgot) or alt (sgpt) more than 2.5x's the uln at the laboratory where the analysis was performed, except if aml-related
    Descrizione

    AST or ALT

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [2]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    11. lvef less than.55 or equivalent by doppler echocardiography
    Descrizione

    11. lvef less than.55 or equivalent by doppler echocardiography

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    12. known intolerance to azacitidine, mannitol, retinoids
    Descrizione

    12. known intolerance to azacitidine, mannitol, retinoids

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0004475 (azacitidine)
    SNOMED
    412329008
    UMLS CUI [1,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,1]
    C0024730 (mannitol)
    SNOMED
    30761007
    UMLS CUI [2,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [3,1]
    C0035339 (Retinoids)
    SNOMED
    116085009
    UMLS CUI [3,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    13. positive serum test for hiv and htlv-1
    Descrizione

    13. positive serum test for hiv and htlv-1

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [2]
    C0020094 (Human T-lymphotropic virus 1)
    SNOMED
    77457007
    LOINC
    LA13550-1
    14. nyha grade 3/4 cardiac disease .
    Descrizione

    14. nyha grade 3/4 cardiac disease .

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1275491 (New York Heart Association Classification)
    SNOMED
    420816009
    LOINC
    LP264302-3
    15. severe infection at inclusion time.
    Descrizione

    15. severe infection at inclusion time.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
    Descrizione

    16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    17. absence of health care insurance (affiliation à un régime de sécurité sociale)
    Descrizione

    17. absence of health care insurance (affiliation à un régime de sécurité sociale)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0021682 (Health Insurance)
    UMLS CUI [1,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    18. participation to any study requiring informed consent
    Descrizione

    18. participation to any study requiring informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT01067274

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    1. aged of 65 to 79 years
    boolean
    C0001779 (UMLS CUI [1])
    AML de novo or AML with myelodysplasia related changes
    Item
    2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"
    boolean
    C0023467 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    C2825139 (UMLS CUI [2])
    AML not previously treated
    Item
    3. not previously treated for aml
    boolean
    C0023467 (UMLS CUI [1,1])
    C0332154 (UMLS CUI [1,2])
    signed informed consent
    Item
    4. signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    APL
    Item
    1. apl in the who classification.
    boolean
    C0023487 (UMLS CUI [1])
    ID.6
    Item
    2. ph1-positive aml or prior ph1-positive disease
    boolean
    aml evolving from a prior mpn
    Item
    3. aml evolving from a prior mpn in the who 2008 classification.
    boolean
    C0280449 (UMLS CUI [1])
    prior chemotherapy or radiotherapy
    Item
    4. prior treatment with chemotherapy or radiotherapy for another tumor
    boolean
    C1514457 (UMLS CUI [1])
    C0279134 (UMLS CUI [2])
    prior malignancy
    Item
    5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
    boolean
    C0006826 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0007099 (UMLS CUI [2])
    C0699893 (UMLS CUI [3])
    hepatic malignancy
    Item
    6. prior advanced malignant hepatic tumor
    boolean
    C0345904 (UMLS CUI [1])
    ECOG
    Item
    7. ecog performance status score > 2
    boolean
    C1520224 (UMLS CUI [1])
    creatinine
    Item
    8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.
    boolean
    C0201976 (UMLS CUI [1])
    bilirubin
    Item
    9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.
    boolean
    C1278039 (UMLS CUI [1])
    AST or ALT
    Item
    10. ast (sgot) or alt (sgpt) more than 2.5x's the uln at the laboratory where the analysis was performed, except if aml-related
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    LVEF
    Item
    11. lvef less than.55 or equivalent by doppler echocardiography
    boolean
    C0428772 (UMLS CUI [1])
    intolerance to azacitidine, mannitol, retinoids
    Item
    12. known intolerance to azacitidine, mannitol, retinoids
    boolean
    C0004475 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C0024730 (UMLS CUI [2,1])
    C0020517 (UMLS CUI [2,2])
    C0035339 (UMLS CUI [3,1])
    C0020517 (UMLS CUI [3,2])
    hiv and htlv-1
    Item
    13. positive serum test for hiv and htlv-1
    boolean
    C0019682 (UMLS CUI [1])
    C0020094 (UMLS CUI [2])
    NYHA
    Item
    14. nyha grade 3/4 cardiac disease .
    boolean
    C1275491 (UMLS CUI [1])
    infection
    Item
    15. severe infection at inclusion time.
    boolean
    C0009450 (UMLS CUI [1])
    comorbidity limiting compliance
    Item
    16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    absence of health care insurance
    Item
    17. absence of health care insurance (affiliation à un régime de sécurité sociale)
    boolean
    C0021682 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    participation to any study requiring informed consent
    Item
    18. participation to any study requiring informed consent
    boolean
    C2348568 (UMLS CUI [1])
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