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ID

15155

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.05.16 19.05.16 -
Hochgeladen am

19. Mai 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

    Englisch

    Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    female gender
    Beschreibung

    Gender

    Datentyp

    boolean

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

    Oestrogen receptor positive breast cancer

    Datentyp

    boolean

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

    Human epidermal growth factor 2 negative carcinoma of breast

    Datentyp

    boolean

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

    Postmenopausal state

    Datentyp

    boolean

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

    H/O: hormone replacement (HRT)

    Datentyp

    boolean

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

    Low grade histologic differentiation | Intermediate grade histologic differentiation

    Datentyp

    boolean

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

    ECOG performance status

    Datentyp

    boolean

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

    Hematologic function Adequate | Normal renal function | Liver function Adequate

    Datentyp

    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
    Beschreibung

    Able to swallow oral medication

    Datentyp

    boolean

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

    Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene

    Datentyp

    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
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pre-menopausal women
    Beschreibung

    Woman Premenopausal

    Datentyp

    boolean

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

    Locally advanced breast cancer | Carcinoma breast stage IV

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Hypersensitivity Estradiol | Intolerance to substance Estradiol

    Datentyp

    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
    Beschreibung

    Ischemic Change Electrocardiography

    Datentyp

    boolean

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

    Cholelithiasis Symptomatic

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium

    Datentyp

    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)
    Beschreibung

    metabolic disturbance | Glucose measurement | Triglycerides measurement

    Datentyp

    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
    Beschreibung

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

    Datentyp

    boolean

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

    Ähnliche Modelle

    Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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