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ID

15780

Beskrivning

Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function; ODM derived from: https://clinicaltrials.gov/show/NCT00169104

Länk

https://clinicaltrials.gov/show/NCT00169104

Nyckelord

  1. 2016-06-13 2016-06-13 -
Uppladdad den

13 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Metastatic Breast Cancer NCT00169104

    Eligibility Metastatic Breast Cancer NCT00169104

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    all patients must have pathological confirmation of carcinoma of the breast.
    Beskrivning

    carcinoma of the breast

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0678222
    patients must have metastatic breast cancer by documented clinical or radiological assessment.
    Beskrivning

    metastatic breast cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036525
    UMLS CUI [1,2]
    C0678222
    immunohistochemical analysis of her-2/neu expression on paraffin-embedded specimens will be performed. her-2/neu overexpression will be qualitatively scored as 0, 1+, 2+, or 3+, with 3+ indicating the strongest positivity. fluorescence in situ hybridization (fish) analyses will also be performed on these patients. patients with 2+ to 3+ overexpression of her-2/neu (membranous staining) are eligible, regardless of the results of the fish analysis.
    Beskrivning

    immunohistochemical analysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021044
    UMLS CUI [1,2]
    C1512413
    age ≥18 years.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    karnofsky performance status ≥ 60%.
    Beskrivning

    karnofsky performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    adequate hepatic, renal, and hematologic function.
    Beskrivning

    function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C0221130
    prior treatment with trastuzumab will be allowed.
    Beskrivning

    trastuzumab

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0728747
    all patients must have adequate cardiac function (defined as left ventricular ejection fraction ≥ 45%) documented by echocardiogram or muga scan.
    Beskrivning

    cardiac function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0013516
    UMLS CUI [3]
    C0521317
    premenopausal women will be required to have a negative urine or serum pregnancy test and to use an effective form of contraception.
    Beskrivning

    pregnancy and contraceptive methods

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0430060
    UMLS CUI [3]
    C0700589
    patients with a history of brain metastases are permitted as long as it has been at least 30 days since definitive treatment, they are clinically stable and a magnetic resonance imaging scan of the brain demonstrates control of the lesion(s).
    Beskrivning

    brain metastases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    all patients must give written informed consent indicating they are aware of the investigational nature of this treatment, as well as the risks and benefits of this protocol.
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    no treatment with chemotherapy or trastuzumab will be allowed within four weeks of study entry.
    Beskrivning

    chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0728747
    prior therapy with vinorelbine.
    Beskrivning

    vinorelbine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0078257
    known history of hypersensitivity to trastuzumab, chinese hamster ovary (cho) cell proteins, or any component of these products.
    Beskrivning

    hypersensitivity to trastuzumab

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0728747
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0085080
    history of current unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months.
    Beskrivning

    unstable angina

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0002965
    UMLS CUI [2,1]
    C0018802
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [3]
    C0027051
    pregnant women are excluded.
    Beskrivning

    pregnancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    history of a known hypersensitivity to e. coli-derived proteins, filgrastim, or any component of the product.
    Beskrivning

    hypersensitivity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0950080
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0210630

    Similar models

    Eligibility Metastatic Breast Cancer NCT00169104

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    carcinoma of the breast
    Item
    all patients must have pathological confirmation of carcinoma of the breast.
    boolean
    C0678222 (UMLS CUI [1])
    metastatic breast cancer
    Item
    patients must have metastatic breast cancer by documented clinical or radiological assessment.
    boolean
    C0036525 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    immunohistochemical analysis
    Item
    immunohistochemical analysis of her-2/neu expression on paraffin-embedded specimens will be performed. her-2/neu overexpression will be qualitatively scored as 0, 1+, 2+, or 3+, with 3+ indicating the strongest positivity. fluorescence in situ hybridization (fish) analyses will also be performed on these patients. patients with 2+ to 3+ overexpression of her-2/neu (membranous staining) are eligible, regardless of the results of the fish analysis.
    boolean
    C0021044 (UMLS CUI [1,1])
    C1512413 (UMLS CUI [1,2])
    age
    Item
    age ≥18 years.
    boolean
    C0001779 (UMLS CUI [1])
    karnofsky performance status
    Item
    karnofsky performance status ≥ 60%.
    boolean
    C0206065 (UMLS CUI [1])
    function
    Item
    adequate hepatic, renal, and hematologic function.
    boolean
    C0232741 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    C0221130 (UMLS CUI [3])
    trastuzumab
    Item
    prior treatment with trastuzumab will be allowed.
    boolean
    C0728747 (UMLS CUI [1])
    cardiac function
    Item
    all patients must have adequate cardiac function (defined as left ventricular ejection fraction ≥ 45%) documented by echocardiogram or muga scan.
    boolean
    C0428772 (UMLS CUI [1])
    C0013516 (UMLS CUI [2])
    C0521317 (UMLS CUI [3])
    pregnancy and contraceptive methods
    Item
    premenopausal women will be required to have a negative urine or serum pregnancy test and to use an effective form of contraception.
    boolean
    C0032961 (UMLS CUI [1])
    C0430060 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    brain metastases
    Item
    patients with a history of brain metastases are permitted as long as it has been at least 30 days since definitive treatment, they are clinically stable and a magnetic resonance imaging scan of the brain demonstrates control of the lesion(s).
    boolean
    C0220650 (UMLS CUI [1])
    informed consent
    Item
    all patients must give written informed consent indicating they are aware of the investigational nature of this treatment, as well as the risks and benefits of this protocol.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    chemotherapy
    Item
    no treatment with chemotherapy or trastuzumab will be allowed within four weeks of study entry.
    boolean
    C0392920 (UMLS CUI [1])
    C0728747 (UMLS CUI [2])
    vinorelbine
    Item
    prior therapy with vinorelbine.
    boolean
    C0078257 (UMLS CUI [1])
    hypersensitivity to trastuzumab
    Item
    known history of hypersensitivity to trastuzumab, chinese hamster ovary (cho) cell proteins, or any component of these products.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0728747 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0085080 (UMLS CUI [2,2])
    unstable angina
    Item
    history of current unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months.
    boolean
    C0002965 (UMLS CUI [1])
    C0018802 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C0027051 (UMLS CUI [3])
    pregnancy
    Item
    pregnant women are excluded.
    boolean
    C0032961 (UMLS CUI [1])
    hypersensitivity
    Item
    history of a known hypersensitivity to e. coli-derived proteins, filgrastim, or any component of the product.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0950080 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0210630 (UMLS CUI [2,2])

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