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ID

16259

Descrizione

Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193076

collegamento

https://clinicaltrials.gov/show/NCT00193076

Keywords

  1. 08/07/16 08/07/16 -
Caricato su

8 luglio 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00193076

    Eligibility Breast Cancer NCT00193076

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    to be included in this study, you must meet the following criteria:
    Descrizione

    ID.1

    Tipo di dati

    boolean

    locally advanced or metastatic breast cancer
    Descrizione

    Locally advanced breast cancer | Carcinoma breast stage IV

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3495949 (Locally advanced breast cancer)
    SNOMED
    1082701000112100
    UMLS CUI [2]
    C0278488 (Carcinoma breast stage IV)
    measurable disease as per recist criteria
    Descrizione

    Measurable Disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    no prior chemotherapy in the metastatic breast setting
    Descrizione

    Prior Chemotherapy Carcinoma breast stage IV

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C0278488 (Carcinoma breast stage IV)
    prior chemotherapy and/or hormonal therapy for early stage breast cancer
    Descrizione

    Prior Chemotherapy Early-Stage Breast Carcinoma | Hormone Therapy Early-Stage Breast Carcinoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C2986665 (Early-Stage Breast Carcinoma)
    UMLS CUI [2,1]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    UMLS CUI [2,2]
    C2986665 (Early-Stage Breast Carcinoma)
    adjuvant herceptin is allowed
    Descrizione

    Herceptin Adjuvant

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0338204 (Herceptin)
    UMLS CUI [1,2]
    C1522673 (Adjuvant)
    prior radiation therapy in either the metastatic or early stage setting
    Descrizione

    prior radiation therapy Carcinoma breast stage IV | prior radiation therapy Early-Stage Breast Carcinoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134 (Prior Radiation Therapy)
    UMLS CUI [1,2]
    C0278488 (Carcinoma breast stage IV)
    UMLS CUI [2,1]
    C0279134 (Prior Radiation Therapy)
    UMLS CUI [2,2]
    C2986665 (Early-Stage Breast Carcinoma)
    patients may have received any number of hormonal therapies
    Descrizione

    Hormone Therapy Quantity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    age >18 years
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    only women are eligible for the study
    Descrizione

    Gender

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    able to perform activities of daily living with minimal assistance
    Descrizione

    Performance of activities of daily living Ability | Assistance Minimal

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1821398 (Performance of activities of daily living)
    UMLS CUI [1,2]
    C0085732 (Ability)
    UMLS CUI [2,1]
    C0557034 (Assisting (procedure))
    SNOMED
    119265000
    UMLS CUI [2,2]
    C0547040 (Minimal)
    SNOMED
    255605001
    LOINC
    LA26031-7
    normal organ and bone marrow function
    Descrizione

    organ function | Bone Marrow function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    UMLS CUI [2,1]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    UMLS CUI [2,2]
    C0031843 (physiological aspects)
    patients who will be receiving trastuzumab must have normal heart function
    Descrizione

    trastuzumab | Cardiac function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0728747 (trastuzumab)
    SNOMED
    327397006
    UMLS CUI [2]
    C0232164 (Cardiac function)
    SNOMED
    86185002
    sign a written informed consent document
    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)
    you cannot participate in this study if any of the following apply to you:
    Descrizione

    Study Subject Participation Status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    received prior chemotherapy for metastatic breast cancer
    Descrizione

    Prior Chemotherapy Carcinoma breast stage IV

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C0278488 (Carcinoma breast stage IV)
    known leptomeningeal carcinomatosis
    Descrizione

    Leptomeningeal Carcinomatosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0220654 (Meningeal Carcinomatosis)
    SNOMED
    230156002
    uncontrolled brain metastasis
    Descrizione

    Metastatic malignant neoplasm to brain Uncontrolled

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    uncontrolled intercurrent illness
    Descrizione

    Intercurrent disease Uncontrolled

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0277557 (Intercurrent disease)
    SNOMED
    88472004
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    pregnant or lactating
    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
    history of other non-breast cancer malignancy
    Descrizione

    Malignant Neoplasms | Breast Carcinoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    received prior chemotherapy for early stage breast cancer within 6 months
    Descrizione

    Prior Chemotherapy Early-Stage Breast Carcinoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C2986665 (Early-Stage Breast Carcinoma)
    please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Descrizione

    criteria Additional | Study Subject Participation Status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161 (criteria)
    UMLS CUI [1,2]
    C1524062 (Additional)
    LOINC
    LP35025-3
    UMLS CUI [2]
    C2348568 (Study Subject Participation Status)

    Similar models

    Eligibility Breast Cancer NCT00193076

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ID.1
    Item
    to be included in this study, you must meet the following criteria:
    boolean
    Locally advanced breast cancer | Carcinoma breast stage IV
    Item
    locally advanced or metastatic breast cancer
    boolean
    C3495949 (UMLS CUI [1])
    C0278488 (UMLS CUI [2])
    Measurable Disease
    Item
    measurable disease as per recist criteria
    boolean
    C1513041 (UMLS CUI [1])
    Prior Chemotherapy Carcinoma breast stage IV
    Item
    no prior chemotherapy in the metastatic breast setting
    boolean
    C1514457 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    Prior Chemotherapy Early-Stage Breast Carcinoma | Hormone Therapy Early-Stage Breast Carcinoma
    Item
    prior chemotherapy and/or hormonal therapy for early stage breast cancer
    boolean
    C1514457 (UMLS CUI [1,1])
    C2986665 (UMLS CUI [1,2])
    C0279025 (UMLS CUI [2,1])
    C2986665 (UMLS CUI [2,2])
    Herceptin Adjuvant
    Item
    adjuvant herceptin is allowed
    boolean
    C0338204 (UMLS CUI [1,1])
    C1522673 (UMLS CUI [1,2])
    prior radiation therapy Carcinoma breast stage IV | prior radiation therapy Early-Stage Breast Carcinoma
    Item
    prior radiation therapy in either the metastatic or early stage setting
    boolean
    C0279134 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    C0279134 (UMLS CUI [2,1])
    C2986665 (UMLS CUI [2,2])
    Hormone Therapy Quantity
    Item
    patients may have received any number of hormonal therapies
    boolean
    C0279025 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Age
    Item
    age >18 years
    boolean
    C0001779 (UMLS CUI [1])
    Gender
    Item
    only women are eligible for the study
    boolean
    C0079399 (UMLS CUI [1])
    Performance of activities of daily living Ability | Assistance Minimal
    Item
    able to perform activities of daily living with minimal assistance
    boolean
    C1821398 (UMLS CUI [1,1])
    C0085732 (UMLS CUI [1,2])
    C0557034 (UMLS CUI [2,1])
    C0547040 (UMLS CUI [2,2])
    organ function | Bone Marrow function
    Item
    normal organ and bone marrow function
    boolean
    C0678852 (UMLS CUI [1])
    C0005953 (UMLS CUI [2,1])
    C0031843 (UMLS CUI [2,2])
    trastuzumab | Cardiac function
    Item
    patients who will be receiving trastuzumab must have normal heart function
    boolean
    C0728747 (UMLS CUI [1])
    C0232164 (UMLS CUI [2])
    Informed consent
    Item
    sign a written informed consent document
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status
    Item
    you cannot participate in this study if any of the following apply to you:
    boolean
    C2348568 (UMLS CUI [1])
    Prior Chemotherapy Carcinoma breast stage IV
    Item
    received prior chemotherapy for metastatic breast cancer
    boolean
    C1514457 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    Leptomeningeal Carcinomatosis
    Item
    known leptomeningeal carcinomatosis
    boolean
    C0220654 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain Uncontrolled
    Item
    uncontrolled brain metastasis
    boolean
    C0220650 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Intercurrent disease Uncontrolled
    Item
    uncontrolled intercurrent illness
    boolean
    C0277557 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Malignant Neoplasms | Breast Carcinoma
    Item
    history of other non-breast cancer malignancy
    boolean
    C0006826 (UMLS CUI [1])
    C0678222 (UMLS CUI [2])
    Prior Chemotherapy Early-Stage Breast Carcinoma
    Item
    received prior chemotherapy for early stage breast cancer within 6 months
    boolean
    C1514457 (UMLS CUI [1,1])
    C2986665 (UMLS CUI [1,2])
    criteria Additional | Study Subject Participation Status
    Item
    please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    boolean
    C0243161 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [2])

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