0 Avaliações

ID

15155

Descrição

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT02238808

Link

https://clinicaltrials.gov/show/NCT02238808

Palavras-chave

  1. 19/05/2016 19/05/2016 -
Transferido a

19 de maio de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

    Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    female gender
    Descrição

    Gender

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    estrogen receptor positive (er+) breast cancer
    Descrição

    Oestrogen receptor positive breast cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2938924
    her2 negative breast cancer
    Descrição

    Human epidermal growth factor 2 negative carcinoma of breast

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2316304
    post-menopausal by greater than 5 years
    Descrição

    Postmenopausal state

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    no previous hormonal replacement therapy
    Descrição

    H/O: hormone replacement (HRT)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0455631
    low to intermediate histologic grade
    Descrição

    Low grade histologic differentiation | Intermediate grade histologic differentiation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1302385
    UMLS CUI [2]
    C1320484
    ecog performance status of 0 of 1
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate hematological, renal and hepatic function is required
    Descrição

    Hematologic function Adequate | Normal renal function | Liver function Adequate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0221130
    UMLS CUI [1,2]
    C0205411
    UMLS CUI [2]
    C0232805
    UMLS CUI [3,1]
    C0232741
    UMLS CUI [3,2]
    C0205411
    ability to take oral medication
    Descrição

    Able to swallow oral medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2712086
    UMLS CUI [1,2]
    C0175795
    patient must have adequate tissue for diagnosis, biomarkers and ki67 assays
    Descrição

    Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1292533
    UMLS CUI [1,2]
    C0205411
    UMLS CUI [1,3]
    C0011900
    UMLS CUI [2]
    C0005516
    UMLS CUI [3]
    C1334508
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pre-menopausal women
    Descrição

    Woman Premenopausal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0043210
    UMLS CUI [1,2]
    C0279752
    locally advanced or metastatic breast cancer
    Descrição

    Locally advanced breast cancer | Carcinoma breast stage IV

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3495949
    UMLS CUI [2]
    C0278488
    current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
    Descrição

    Neoadjuvant Therapy | Chemotherapy Regimen | Hormone Therapy | Adrenal Cortex Hormones | Therapeutic radiology procedure | Malignant Neoplasms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0600558
    UMLS CUI [2]
    C0392920
    UMLS CUI [3]
    C0279025
    UMLS CUI [4]
    C0001617
    UMLS CUI [5]
    C1522449
    UMLS CUI [6]
    C0006826
    known hypersensitivity or intolerance to estradiol
    Descrição

    Hypersensitivity Estradiol | Intolerance to substance Estradiol

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0014912
    UMLS CUI [2,1]
    C1744706
    UMLS CUI [2,2]
    C0014912
    ischemic changes on baseline electrocardiogram
    Descrição

    Ischemic Change Electrocardiography

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2826576
    UMLS CUI [1,2]
    C1623258
    symptomatic but untreated cholelithiasis
    Descrição

    Cholelithiasis Symptomatic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0008350
    UMLS CUI [1,2]
    C0231220
    history of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
    Descrição

    Deep Vein Thrombosis | Pulmonary Embolism | Cerebrovascular accident | Acute myocardial infarction | Congestive heart failure | Hypertensive disease | Thrombophilia, hereditary

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0149871
    UMLS CUI [2]
    C0034065
    UMLS CUI [3]
    C0038454
    UMLS CUI [4]
    C0155626
    UMLS CUI [5]
    C0018802
    UMLS CUI [6]
    C0020538
    UMLS CUI [7]
    C2584620
    undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
    Descrição

    Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2979982
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [2]
    C0007103
    untreated metabolic disturbances (glucose > 11.0 mmol/l and triglycerides > 400 mg/dl)
    Descrição

    metabolic disturbance | Glucose measurement | Triglycerides measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0746556
    UMLS CUI [2]
    C0337438
    UMLS CUI [3]
    C0202236
    current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme cyp3a4
    Descrição

    Therapeutic procedure Pharmaceutical Preparations | Inhibitors Cytochrome P-450 CYP3A4 Inducers

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [2,1]
    C0243077
    UMLS CUI [2,2]
    C3850041

    Similar models

    Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender
    Item
    female gender
    boolean
    C0079399 (UMLS CUI [1])
    Oestrogen receptor positive breast cancer
    Item
    estrogen receptor positive (er+) breast cancer
    boolean
    C2938924 (UMLS CUI [1])
    Human epidermal growth factor 2 negative carcinoma of breast
    Item
    her2 negative breast cancer
    boolean
    C2316304 (UMLS CUI [1])
    Postmenopausal state
    Item
    post-menopausal by greater than 5 years
    boolean
    C0232970 (UMLS CUI [1])
    H/O: hormone replacement (HRT)
    Item
    no previous hormonal replacement therapy
    boolean
    C0455631 (UMLS CUI [1])
    Low grade histologic differentiation | Intermediate grade histologic differentiation
    Item
    low to intermediate histologic grade
    boolean
    C1302385 (UMLS CUI [1])
    C1320484 (UMLS CUI [2])
    ECOG performance status
    Item
    ecog performance status of 0 of 1
    boolean
    C1520224 (UMLS CUI [1])
    Hematologic function Adequate | Normal renal function | Liver function Adequate
    Item
    adequate hematological, renal and hepatic function is required
    boolean
    C0221130 (UMLS CUI [1,1])
    C0205411 (UMLS CUI [1,2])
    C0232805 (UMLS CUI [2])
    C0232741 (UMLS CUI [3,1])
    C0205411 (UMLS CUI [3,2])
    Able to swallow oral medication
    Item
    ability to take oral medication
    boolean
    C2712086 (UMLS CUI [1,1])
    C0175795 (UMLS CUI [1,2])
    Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene
    Item
    patient must have adequate tissue for diagnosis, biomarkers and ki67 assays
    boolean
    C1292533 (UMLS CUI [1,1])
    C0205411 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [1,3])
    C0005516 (UMLS CUI [2])
    C1334508 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Woman Premenopausal
    Item
    pre-menopausal women
    boolean
    C0043210 (UMLS CUI [1,1])
    C0279752 (UMLS CUI [1,2])
    Locally advanced breast cancer | Carcinoma breast stage IV
    Item
    locally advanced or metastatic breast cancer
    boolean
    C3495949 (UMLS CUI [1])
    C0278488 (UMLS CUI [2])
    Neoadjuvant Therapy | Chemotherapy Regimen | Hormone Therapy | Adrenal Cortex Hormones | Therapeutic radiology procedure | Malignant Neoplasms
    Item
    current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
    boolean
    C0600558 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    C0279025 (UMLS CUI [3])
    C0001617 (UMLS CUI [4])
    C1522449 (UMLS CUI [5])
    C0006826 (UMLS CUI [6])
    Hypersensitivity Estradiol | Intolerance to substance Estradiol
    Item
    known hypersensitivity or intolerance to estradiol
    boolean
    C0020517 (UMLS CUI [1,1])
    C0014912 (UMLS CUI [1,2])
    C1744706 (UMLS CUI [2,1])
    C0014912 (UMLS CUI [2,2])
    Ischemic Change Electrocardiography
    Item
    ischemic changes on baseline electrocardiogram
    boolean
    C2826576 (UMLS CUI [1,1])
    C1623258 (UMLS CUI [1,2])
    Cholelithiasis Symptomatic
    Item
    symptomatic but untreated cholelithiasis
    boolean
    C0008350 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    Deep Vein Thrombosis | Pulmonary Embolism | Cerebrovascular accident | Acute myocardial infarction | Congestive heart failure | Hypertensive disease | Thrombophilia, hereditary
    Item
    history of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
    boolean
    C0149871 (UMLS CUI [1])
    C0034065 (UMLS CUI [2])
    C0038454 (UMLS CUI [3])
    C0155626 (UMLS CUI [4])
    C0018802 (UMLS CUI [5])
    C0020538 (UMLS CUI [6])
    C2584620 (UMLS CUI [7])
    Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium
    Item
    undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
    boolean
    C2979982 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C0007103 (UMLS CUI [2])
    metabolic disturbance | Glucose measurement | Triglycerides measurement
    Item
    untreated metabolic disturbances (glucose > 11.0 mmol/l and triglycerides > 400 mg/dl)
    boolean
    C0746556 (UMLS CUI [1])
    C0337438 (UMLS CUI [2])
    C0202236 (UMLS CUI [3])
    Therapeutic procedure Pharmaceutical Preparations | Inhibitors Cytochrome P-450 CYP3A4 Inducers
    Item
    current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme cyp3a4
    boolean
    C0087111 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0243077 (UMLS CUI [2,1])
    C3850041 (UMLS CUI [2,2])

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