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ID

44395

Description

Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes; ODM derived from: https://clinicaltrials.gov/show/NCT00966043

Link

https://clinicaltrials.gov/show/NCT00966043

Keywords

Versions (2)
  1. 11/8/17 11/8/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

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September 20, 2021

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License

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00966043

    English

    Eligibility Breast Neoplasms NCT00966043

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    female > 18 years of age
    Description

    Gender | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    written and voluntary informed consent understood signed and dated
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
    Description

    Breast adenocarcinoma Invasive Measurable | Breast adenocarcinoma Amenable Curative treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0858252 (Adenocarcinoma of breast)
    SNOMED
    865954003
    UMLS CUI [1,2]
    C0205281 (Invasive)
    SNOMED
    10179008
    LOINC
    LP102225-2
    UMLS CUI [1,3]
    C1513040 (Measurable)
    UMLS CUI [2,1]
    C0858252 (Adenocarcinoma of breast)
    SNOMED
    865954003
    UMLS CUI [2,2]
    C3900053 (Amenable)
    UMLS CUI [2,3]
    C1273390 (curative treatment)
    patients must be postmenopausal as defined by criteria in appendix 1.
    Description

    Postmenopausal state

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
    Description

    Breast Carcinoma Estrogen receptor positive Immunohistochemistry

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    UMLS CUI [1,2]
    C0279754 (Estrogen receptor positive)
    UMLS CUI [1,3]
    C0021044 (Immunohistochemistry)
    SNOMED
    708097004
    prior endocrine tamoxifen therapy is not allowed
    Description

    Exclusion Tamoxifen Hormone Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2828389 (Exclusion)
    UMLS CUI [1,2]
    C0039286 (tamoxifen)
    SNOMED
    75959001
    UMLS CUI [1,3]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    patients are not previously treated with an endocrine agent or hormone replacement therapy needs being stopped for at least 6 months.
    Description

    Hormone preparation Absent | Hormone replacement therapy To be stopped

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019932 (Hormones)
    SNOMED
    22091006
    LOINC
    LA4003-5
    UMLS CUI [1,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,1]
    C0282402 (Hormone replacement therapy)
    SNOMED
    266717002
    UMLS CUI [2,2]
    C1272691 (To be stopped)
    SNOMED
    385654001
    prior chemotherapy and radiotherapy is allowed
    Description

    Prior Chemotherapy | Prior radiation therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [2]
    C0279134 (Prior Radiation Therapy)
    adequate renal and liver function serum creatinine and serum bilirubin ≤ 1.5 x uln serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases)
    Description

    Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Serum alanine aminotransferase measurement | AST serum measurement | Secondary malignant neoplasm of liver

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [2]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [3]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [4]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [5]
    C1883008 (serum alanine aminotransferase measurement)
    UMLS CUI [6]
    C1261155 (AST serum measurement)
    SNOMED
    250641004
    UMLS CUI [7]
    C0494165 (Secondary malignant neoplasm of liver)
    SNOMED
    94381002
    serum calcium should be ≤ 11,6 mg/dl
    Description

    Serum calcium measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0728876 (Serum calcium measurement)
    SNOMED
    271240001
    ecog performance status 0,1,2 (appendix 2)
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    male
    Description

    Gender

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
    Description

    Life threatening illness Requirement Response quick | Hepatic Involvement Extensive | Pulmonary involvement Extensive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3846017 (Life threatening illness)
    LOINC
    LA19516-6
    UMLS CUI [1,2]
    C1514873 (Requirement)
    UMLS CUI [1,3]
    C1704632 (Disease Response)
    UMLS CUI [1,4]
    C0456962 (Rapid)
    SNOMED
    277748003
    LOINC
    LA24868-4
    UMLS CUI [2,1]
    C0441932 (Hepatic Involvement)
    SNOMED
    258322007
    UMLS CUI [2,2]
    C0205231 (Extensive)
    SNOMED
    41118005
    UMLS CUI [3,1]
    C0748159 (pulmonary involvement)
    UMLS CUI [3,2]
    C0205231 (Extensive)
    SNOMED
    41118005
    use of any endocrine treatment or recent/current use of hormone replacement therapy.
    Description

    Hormone Therapy | Hormone replacement therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    UMLS CUI [2]
    C0282402 (Hormone replacement therapy)
    SNOMED
    266717002
    contra indication for tamoxifen: history of dvt/vaginal bleeding of unknown origin
    Description

    Medical contraindication Tamoxifen | Deep Vein Thrombosis | Vaginal Hemorrhage Unknown origin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI [1,2]
    C0039286 (tamoxifen)
    SNOMED
    75959001
    UMLS CUI [2]
    C0149871 (Deep Vein Thrombosis)
    SNOMED
    128053003
    UMLS CUI [3,1]
    C2979982 (Vaginal Hemorrhage)
    SNOMED
    289530006
    UMLS CUI [3,2]
    C0332240 (Unknown (origin) (qualifier value))
    SNOMED
    54690008
    dementia
    Description

    Dementia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    history of other malignancy that may interfere with at least 6 months of tamoxifen therapy
    Description

    Cancer Other Interferes with Tamoxifen Therapeutic procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707251 (Cancer Other)
    UMLS CUI [1,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [1,3]
    C0039286 (tamoxifen)
    SNOMED
    75959001
    UMLS CUI [1,4]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
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    Similar models

    Eligibility Breast Neoplasms NCT00966043

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Age
    Item
    female > 18 years of age
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Informed Consent
    Item
    written and voluntary informed consent understood signed and dated
    boolean
    C0021430 (UMLS CUI [1])
    Breast adenocarcinoma Invasive Measurable | Breast adenocarcinoma Amenable Curative treatment
    Item
    histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
    boolean
    C0858252 (UMLS CUI [1,1])
    C0205281 (UMLS CUI [1,2])
    C1513040 (UMLS CUI [1,3])
    C0858252 (UMLS CUI [2,1])
    C3900053 (UMLS CUI [2,2])
    C1273390 (UMLS CUI [2,3])
    Postmenopausal state
    Item
    patients must be postmenopausal as defined by criteria in appendix 1.
    boolean
    C0232970 (UMLS CUI [1])
    Breast Carcinoma Estrogen receptor positive Immunohistochemistry
    Item
    breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
    boolean
    C0678222 (UMLS CUI [1,1])
    C0279754 (UMLS CUI [1,2])
    C0021044 (UMLS CUI [1,3])
    Exclusion Tamoxifen Hormone Therapy
    Item
    prior endocrine tamoxifen therapy is not allowed
    boolean
    C2828389 (UMLS CUI [1,1])
    C0039286 (UMLS CUI [1,2])
    C0279025 (UMLS CUI [1,3])
    Hormone preparation Absent | Hormone replacement therapy To be stopped
    Item
    patients are not previously treated with an endocrine agent or hormone replacement therapy needs being stopped for at least 6 months.
    boolean
    C0019932 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0282402 (UMLS CUI [2,1])
    C1272691 (UMLS CUI [2,2])
    Prior Chemotherapy | Prior radiation therapy
    Item
    prior chemotherapy and radiotherapy is allowed
    boolean
    C1514457 (UMLS CUI [1])
    C0279134 (UMLS CUI [2])
    Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Serum alanine aminotransferase measurement | AST serum measurement | Secondary malignant neoplasm of liver
    Item
    adequate renal and liver function serum creatinine and serum bilirubin ≤ 1.5 x uln serum alt and ast ≤ 2.5 x uln (or ≤ 5 in case of liver metastases)
    boolean
    C0232804 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C1883008 (UMLS CUI [5])
    C1261155 (UMLS CUI [6])
    C0494165 (UMLS CUI [7])
    Serum calcium measurement
    Item
    serum calcium should be ≤ 11,6 mg/dl
    boolean
    C0728876 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0,1,2 (appendix 2)
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Gender
    Item
    male
    boolean
    C0079399 (UMLS CUI [1])
    Life threatening illness Requirement Response quick | Hepatic Involvement Extensive | Pulmonary involvement Extensive
    Item
    life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
    boolean
    C3846017 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C1704632 (UMLS CUI [1,3])
    C0456962 (UMLS CUI [1,4])
    C0441932 (UMLS CUI [2,1])
    C0205231 (UMLS CUI [2,2])
    C0748159 (UMLS CUI [3,1])
    C0205231 (UMLS CUI [3,2])
    Hormone Therapy | Hormone replacement therapy
    Item
    use of any endocrine treatment or recent/current use of hormone replacement therapy.
    boolean
    C0279025 (UMLS CUI [1])
    C0282402 (UMLS CUI [2])
    Medical contraindication Tamoxifen | Deep Vein Thrombosis | Vaginal Hemorrhage Unknown origin
    Item
    contra indication for tamoxifen: history of dvt/vaginal bleeding of unknown origin
    boolean
    C1301624 (UMLS CUI [1,1])
    C0039286 (UMLS CUI [1,2])
    C0149871 (UMLS CUI [2])
    C2979982 (UMLS CUI [3,1])
    C0332240 (UMLS CUI [3,2])
    Dementia
    Item
    dementia
    boolean
    C0497327 (UMLS CUI [1])
    Cancer Other Interferes with Tamoxifen Therapeutic procedure
    Item
    history of other malignancy that may interfere with at least 6 months of tamoxifen therapy
    boolean
    C1707251 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0039286 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [1,4])
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