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ID

17354

Descrizione

ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00140660

collegamento

https://clinicaltrials.gov/show/NCT00140660

Keywords

  1. 07/09/16 07/09/16 -
  2. 07/09/16 07/09/16 -
  3. 07/09/16 07/09/16 -
Caricato su

7 settembre 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Diffuse Large Cell Lymphoma NCT00140660

    Eligibility Diffuse Large Cell Lymphoma NCT00140660

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).
    Descrizione

    Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744 (Diffuse Large B-Cell Lymphoma)
    SNOMED
    109969005
    UMLS CUI [1,2]
    C0882818 (Cell positive for CD20 antigen)
    SNOMED
    116754005
    age from 18 to 65 years.
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patient not previously treated.
    Descrizione

    Patient untreated

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C0332155 (Did not receive therapy or drug for)
    SNOMED
    25265005
    ann arbor stage i or ii.
    Descrizione

    Ann Arbor lymphoma staging system

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0432516 (Ann Arbor lymphoma staging system)
    SNOMED
    254372002
    ecog performance status < 2.
    Descrizione

    ECOG performance status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    normal ldh.
    Descrizione

    Blood lactate dehydrogenase normal

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0853788 (Blood lactate dehydrogenase normal)
    negative hiv, hbv and hcv serologies 4 weeks (except after vaccination).
    Descrizione

    HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Vaccination

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0481430 (HIV negative finding)
    SNOMED
    165815009
    UMLS CUI [2,1]
    C0744837 (hepatitis b serology)
    UMLS CUI [2,2]
    C1513916 (Negative Finding)
    LOINC
    LA6577-6
    UMLS CUI [3,1]
    C0850489 (hepatitis C serology test)
    UMLS CUI [3,2]
    C1513916 (Negative Finding)
    LOINC
    LA6577-6
    UMLS CUI [4]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    having previously signed a written informed consent.
    Descrizione

    Informed consent

    Tipo di dati

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    any other histological type of lymphoma. vany history of treated or non-treated indolent lymphoma. however, patients not previously diagnosed and having a diffuse large b-cell lymphoma with some small cell infiltration in lymph node may be included.
    Descrizione

    Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Lymph nodes

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    UMLS CUI [1,2]
    C0449574 (Histologic type)
    SNOMED
    263541007
    LOINC
    LP72692-4
    UMLS CUI [2]
    C1334170 (Indolent Non-Hodgkin Lymphoma)
    UMLS CUI [3]
    C0079744 (Diffuse Large B-Cell Lymphoma)
    SNOMED
    109969005
    UMLS CUI [4,1]
    C1692321 (Cellular infiltrate)
    UMLS CUI [4,2]
    C0024204 (lymph nodes)
    SNOMED
    59441001
    central nervous system or meningeal involvement by lymphoma.
    Descrizione

    Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3714787 (Central Nervous System)
    SNOMED
    21483005
    LOINC
    LA4174-4
    UMLS CUI [1,2]
    C1314939 (Involvement with)
    SNOMED
    248448006
    LOINC
    LA26536-5
    UMLS CUI [1,3]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    UMLS CUI [2,1]
    C0025285 (Meninges)
    SNOMED
    1231004
    UMLS CUI [2,2]
    C1314939 (Involvement with)
    SNOMED
    248448006
    LOINC
    LA26536-5
    UMLS CUI [2,3]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    contra-indication to any drug contained in the chemotherapy regimens.
    Descrizione

    Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [1,4]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).
    Descrizione

    Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [1,2]
    C0542537 (Poor - grade value)
    SNOMED
    255351007
    UMLS CUI [2]
    C0201975 (Creatinine measurement)
    SNOMED
    70901006
    UMLS CUI [3,1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [3,2]
    C0542537 (Poor - grade value)
    SNOMED
    255351007
    UMLS CUI [4]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    UMLS CUI [5]
    C0438717 (Transaminases increased)
    poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l.
    Descrizione

    Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2748959 (Few mature neutrophils in the bone marrow)
    UMLS CUI [2]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [3]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
    Descrizione

    Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0699893 (Skin carcinoma)
    UMLS CUI [3]
    C0851140 (Carcinoma in situ of uterine cervix)
    SNOMED
    92564006
    any serious active disease (according to the investigator's decision).
    Descrizione

    Disease Serious

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
    Descrizione

    Investigational New Drugs | Chemotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    UMLS CUI [2]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    pregnant or lactating women
    Descrizione

    Pregnancy | Breast Feeding

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    adult patient under tutelage.
    Descrizione

    Adult Associated with guardianship

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0001675 (Adult)
    SNOMED
    133936004
    LOINC
    LA13524-6
    UMLS CUI [1,2]
    C0332281 (Associated with)
    SNOMED
    47429007
    UMLS CUI [1,3]
    C0870627 (guardianship)

    Similar models

    Eligibility Diffuse Large Cell Lymphoma NCT00140660

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen
    Item
    patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).
    boolean
    C0079744 (UMLS CUI [1,1])
    C0882818 (UMLS CUI [1,2])
    Age
    Item
    age from 18 to 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    Patient untreated
    Item
    patient not previously treated.
    boolean
    C0030705 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    Ann Arbor lymphoma staging system
    Item
    ann arbor stage i or ii.
    boolean
    C0432516 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status < 2.
    boolean
    C1520224 (UMLS CUI [1])
    Blood lactate dehydrogenase normal
    Item
    normal ldh.
    boolean
    C0853788 (UMLS CUI [1])
    HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Vaccination
    Item
    negative hiv, hbv and hcv serologies 4 weeks (except after vaccination).
    boolean
    C0481430 (UMLS CUI [1])
    C0744837 (UMLS CUI [2,1])
    C1513916 (UMLS CUI [2,2])
    C0850489 (UMLS CUI [3,1])
    C1513916 (UMLS CUI [3,2])
    C0042196 (UMLS CUI [4])
    Informed consent
    Item
    having previously signed a written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Lymph nodes
    Item
    any other histological type of lymphoma. vany history of treated or non-treated indolent lymphoma. however, patients not previously diagnosed and having a diffuse large b-cell lymphoma with some small cell infiltration in lymph node may be included.
    boolean
    C0024299 (UMLS CUI [1,1])
    C0449574 (UMLS CUI [1,2])
    C1334170 (UMLS CUI [2])
    C0079744 (UMLS CUI [3])
    C1692321 (UMLS CUI [4,1])
    C0024204 (UMLS CUI [4,2])
    Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma
    Item
    central nervous system or meningeal involvement by lymphoma.
    boolean
    C3714787 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    C0025285 (UMLS CUI [2,1])
    C1314939 (UMLS CUI [2,2])
    C0024299 (UMLS CUI [2,3])
    Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen
    Item
    contra-indication to any drug contained in the chemotherapy regimens.
    boolean
    C1301624 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [1,4])
    Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased
    Item
    poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).
    boolean
    C0232804 (UMLS CUI [1,1])
    C0542537 (UMLS CUI [1,2])
    C0201975 (UMLS CUI [2])
    C0232741 (UMLS CUI [3,1])
    C0542537 (UMLS CUI [3,2])
    C0201913 (UMLS CUI [4])
    C0438717 (UMLS CUI [5])
    Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement
    Item
    poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l.
    boolean
    C2748959 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
    Item
    any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
    boolean
    C0006826 (UMLS CUI [1])
    C0699893 (UMLS CUI [2])
    C0851140 (UMLS CUI [3])
    Disease Serious
    Item
    any serious active disease (according to the investigator's decision).
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Investigational New Drugs | Chemotherapy
    Item
    treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
    boolean
    C0013230 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Adult Associated with guardianship
    Item
    adult patient under tutelage.
    boolean
    C0001675 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0870627 (UMLS CUI [1,3])

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