0 Ratings

ID

13389

Description

Neoadjuvant Herceptin in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00133796

Link

https://clinicaltrials.gov/show/NCT00133796

Keywords

  1. 2/10/16 2/10/16 -
Uploaded on

February 10, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00133796

    Eligibility Breast Cancer NCT00133796

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    All patients must be female.
    Description

    gender

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    Informed consent must be signed.
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
    Description

    locally advanced breast cancers

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677984
    UMLS CUI [1,2]
    C0006141
    UMLS CUI [2,1]
    C0006826
    UMLS CUI [2,2]
    C0006141
    UMLS CUI [2,3]
    C0205225
    UMLS CUI [3,1]
    C0009488
    UMLS CUI [3,2]
    C0027627
    Her2/neu overexpressing tumors defined as herceptest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive.
    Description

    Her2neu overexpressing tumors

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960398
    Negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
    Description

    pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430060
    kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
    Description

    kidney and liver function tests

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232805
    UMLS CUI [2]
    C0232741
    Performance status (world health organization [who] scale) < 2 and life expectancy > 6 months.
    Description

    performance status and life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0023671
    Age > 18.
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    No metastatic disease without concomitant primary breast cancer.
    Description

    primary breast cancer and metastatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0006141
    UMLS CUI [1,3]
    C0205225
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0027627
    No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
    Description

    other malignancies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
    Description

    pregnancy and contraceptive use

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C1999124
    Severe underlying chronic illness or disease.
    Description

    severe comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    Cardiomyopathy or baseline left ventricular ejection fraction (lvef) < 50%.
    Description

    cardiomyopathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0878544
    UMLS CUI [2]
    C0428772
    Patients on other investigational drugs while on study.
    Description

    participation in another trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Severe or uncontrolled hypertension defined as blood pressure (bp) > 180/100 on three separate occasions.
    Description

    hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020538
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C1868885
    UMLS CUI [3]
    C0005823
    History of congestive heart failure.
    Description

    history of CHF

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    History of coronary arterial disease.
    Description

    history of CAD

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1956346

    Similar models

    Eligibility Breast Cancer NCT00133796

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender
    Item
    All patients must be female.
    boolean
    C0079399 (UMLS CUI [1])
    informed consent
    Item
    Informed consent must be signed.
    boolean
    C0021430 (UMLS CUI [1])
    locally advanced breast cancers
    Item
    Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
    boolean
    C0677984 (UMLS CUI [1,1])
    C0006141 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [2,1])
    C0006141 (UMLS CUI [2,2])
    C0205225 (UMLS CUI [2,3])
    C0009488 (UMLS CUI [3,1])
    C0027627 (UMLS CUI [3,2])
    Her2neu overexpressing tumors
    Item
    Her2/neu overexpressing tumors defined as herceptest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive.
    boolean
    C1960398 (UMLS CUI [1])
    pregnancy test
    Item
    Negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
    boolean
    C0430060 (UMLS CUI [1])
    kidney and liver function tests
    Item
    kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
    boolean
    C0232805 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    performance status and life expectancy
    Item
    Performance status (world health organization [who] scale) < 2 and life expectancy > 6 months.
    boolean
    C1520224 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    age
    Item
    Age > 18.
    boolean
    C0001779 (UMLS CUI [1])
    primary breast cancer and metastatic disease
    Item
    No metastatic disease without concomitant primary breast cancer.
    boolean
    C0006826 (UMLS CUI [1,1])
    C0006141 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C0027627 (UMLS CUI [2,2])
    other malignancies
    Item
    No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
    boolean
    C0006826 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnancy and contraceptive use
    Item
    Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C1999124 (UMLS CUI [3])
    severe comorbidity
    Item
    Severe underlying chronic illness or disease.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    cardiomyopathy
    Item
    Cardiomyopathy or baseline left ventricular ejection fraction (lvef) < 50%.
    boolean
    C0878544 (UMLS CUI [1])
    C0428772 (UMLS CUI [2])
    participation in another trial
    Item
    Patients on other investigational drugs while on study.
    boolean
    C2348568 (UMLS CUI [1])
    hypertension
    Item
    Severe or uncontrolled hypertension defined as blood pressure (bp) > 180/100 on three separate occasions.
    boolean
    C0020538 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1868885 (UMLS CUI [2])
    C0005823 (UMLS CUI [3])
    history of CHF
    Item
    History of congestive heart failure.
    boolean
    C0018802 (UMLS CUI [1])
    history of CAD
    Item
    History of coronary arterial disease.
    boolean
    C1956346 (UMLS CUI [1])

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