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ID

15592

Description

ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00046514

Lien

https://clinicaltrials.gov/show/NCT00046514

Mots-clés

  1. 04/06/2016 04/06/2016 -
Téléchargé le

4 juin 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Breast Neoplasms NCT00046514

    Eligibility Breast Neoplasms NCT00046514

    Criteria
    Description

    Criteria

    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    Description

    negative serum pregnancy test

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0430061 (Serum pregnancy test negative)
    SNOMED
    166435006
    eighteen years of age or older
    Description

    age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    karnofsky perfomance status of 70% or 0-2 swog performance status
    Description

    karnofsky perfomance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
    Description

    no other malignancy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    measurable disease
    Description

    measurable disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    suitable candidate for treatment with paclitaxel
    Description

    treatment with paclitaxel

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0144576 (paclitaxel)
    SNOMED
    67735003
    UMLS CUI [1,2]
    C0332149 (Possible)
    SNOMED
    371930009
    LOINC
    LA15097-1
    previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
    Description

    previously treated with taxol

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0144576 (paclitaxel)
    SNOMED
    67735003
    if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
    Description

    blood

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    UMLS CUI [2]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [3]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
    Description

    blood measurements baseline

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [2]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [3]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [4]
    C0201850 (Alkaline phosphatase measurement)
    SNOMED
    88810008
    UMLS CUI [5]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    patient has an expected survival of at least 12 weeks
    Description

    expected survival

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    patient or his/her representative has signed an informed consent statement
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)

    Similar models

    Eligibility Breast Neoplasms NCT00046514

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    negative serum pregnancy test
    Item
    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    boolean
    C0430061 (UMLS CUI [1])
    age
    Item
    eighteen years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    karnofsky perfomance status
    Item
    karnofsky perfomance status of 70% or 0-2 swog performance status
    boolean
    C0206065 (UMLS CUI [1])
    no other malignancy
    Item
    no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    measurable disease
    Item
    measurable disease
    boolean
    C1513041 (UMLS CUI [1])
    treatment with paclitaxel
    Item
    suitable candidate for treatment with paclitaxel
    boolean
    C0144576 (UMLS CUI [1,1])
    C0332149 (UMLS CUI [1,2])
    previously treated with taxol
    Item
    previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
    boolean
    C0144576 (UMLS CUI [1])
    blood
    Item
    if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
    boolean
    C0019046 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0005821 (UMLS CUI [3])
    blood measurements baseline
    Item
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
    boolean
    C1278039 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201850 (UMLS CUI [4])
    C0201976 (UMLS CUI [5])
    expected survival
    Item
    patient has an expected survival of at least 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    informed consent
    Item
    patient or his/her representative has signed an informed consent statement
    boolean
    C0021430 (UMLS CUI [1])

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