0 Ratings

ID

17738

Description

Capecitabine in Women With Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00148720

Link

https://clinicaltrials.gov/show/NCT00148720

Keywords

  1. 9/30/16 9/30/16 -
Uploaded on

September 30, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Invasive Breast Carcinoma NCT00148720

    Eligibility Invasive Breast Carcinoma NCT00148720

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histological confirmation of primary invasive breast cancer
    Description

    Primary invasive malignant neoplasm of female breast

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4076461
    stage i-iii operable breast cancer.
    Description

    Breast Carcinoma Operable | TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C0205188
    UMLS CUI [2]
    C3258246
    primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
    Description

    primary tumor size | Radiographic imaging | Palpation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677930
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2]
    C0457276
    UMLS CUI [3]
    C0030247
    women greater than 18 years of age
    Description

    Gender | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    ecog performance status 0-1
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    wbc > 4000/mm3
    Description

    White Blood Cell Count procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    platelet count > 100,000/mm3
    Description

    Platelet Count measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    sgot < 2x uln
    Description

    Aspartate aminotransferase measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    calculated creatinine clearance > 50ml/min
    Description

    Creatinine clearance measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    evidence of metastatic (stage iv) cancer on physical exam or any diagnostic study.
    Description

    Neoplasm Metastasis Evidence of | Carcinoma breast stage IV | Physical Examination | Diagnostic tests

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2]
    C0278488
    UMLS CUI [3]
    C0031809
    UMLS CUI [4]
    C0086143
    pregnant or breast-feeding women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    inflammatory breast cancer
    Description

    Inflammatory Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278601
    her2 positive disease
    Description

    HER2-positive carcinoma of breast

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960398
    history of hypersensitivity to a 5-fu or known dihydropyrimidine dehydrogenase (dpd) deficiency
    Description

    Hypersensitivity Fluorouracil | Dihydropyrimidine Dehydrogenase Deficiency

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0016360
    UMLS CUI [2]
    C1959620
    uncontrolled intercurrent illness
    Description

    Intercurrent disease Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0277557
    UMLS CUI [1,2]
    C0205318
    prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
    Description

    Breast Carcinoma Previous | irradiation of breast Previous | Prior Chemotherapy | Prior Chemotherapy High dose | Stem cell transplant | Bone Marrow Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [2,1]
    C2148528
    UMLS CUI [2,2]
    C0205156
    UMLS CUI [3]
    C1514457
    UMLS CUI [4,1]
    C1514457
    UMLS CUI [4,2]
    C0444956
    UMLS CUI [5]
    C1504389
    UMLS CUI [6]
    C0005961
    excisional biopsy performed prior to enrollment
    Description

    Excision biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0184921
    uncontrolled coagulopathy
    Description

    Blood Coagulation Disorder Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005779
    UMLS CUI [1,2]
    C0205318
    lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
    Description

    upper gastrointestinal tract Integrity Physical Lacking | Malabsorption Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1268997
    UMLS CUI [1,2]
    C1947912
    UMLS CUI [1,3]
    C0205485
    UMLS CUI [1,4]
    C0332268
    UMLS CUI [2]
    C0024523

    Similar models

    Eligibility Invasive Breast Carcinoma NCT00148720

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Primary invasive malignant neoplasm of female breast
    Item
    histological confirmation of primary invasive breast cancer
    boolean
    C4076461 (UMLS CUI [1])
    Breast Carcinoma Operable | TNM clinical staging
    Item
    stage i-iii operable breast cancer.
    boolean
    C0678222 (UMLS CUI [1,1])
    C0205188 (UMLS CUI [1,2])
    C3258246 (UMLS CUI [2])
    primary tumor size | Radiographic imaging | Palpation
    Item
    primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
    boolean
    C0677930 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0457276 (UMLS CUI [2])
    C0030247 (UMLS CUI [3])
    Gender | Age
    Item
    women greater than 18 years of age
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    ECOG performance status
    Item
    ecog performance status 0-1
    boolean
    C1520224 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    wbc > 4000/mm3
    boolean
    C0023508 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelet count > 100,000/mm3
    boolean
    C0032181 (UMLS CUI [1])
    Aspartate aminotransferase measurement
    Item
    sgot < 2x uln
    boolean
    C0201899 (UMLS CUI [1])
    Creatinine clearance measurement
    Item
    calculated creatinine clearance > 50ml/min
    boolean
    C0373595 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Neoplasm Metastasis Evidence of | Carcinoma breast stage IV | Physical Examination | Diagnostic tests
    Item
    evidence of metastatic (stage iv) cancer on physical exam or any diagnostic study.
    boolean
    C0027627 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0278488 (UMLS CUI [2])
    C0031809 (UMLS CUI [3])
    C0086143 (UMLS CUI [4])
    Pregnancy | Breast Feeding
    Item
    pregnant or breast-feeding women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Inflammatory Breast Carcinoma
    Item
    inflammatory breast cancer
    boolean
    C0278601 (UMLS CUI [1])
    HER2-positive carcinoma of breast
    Item
    her2 positive disease
    boolean
    C1960398 (UMLS CUI [1])
    Hypersensitivity Fluorouracil | Dihydropyrimidine Dehydrogenase Deficiency
    Item
    history of hypersensitivity to a 5-fu or known dihydropyrimidine dehydrogenase (dpd) deficiency
    boolean
    C0020517 (UMLS CUI [1,1])
    C0016360 (UMLS CUI [1,2])
    C1959620 (UMLS CUI [2])
    Intercurrent disease Uncontrolled
    Item
    uncontrolled intercurrent illness
    boolean
    C0277557 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Breast Carcinoma Previous | irradiation of breast Previous | Prior Chemotherapy | Prior Chemotherapy High dose | Stem cell transplant | Bone Marrow Transplantation
    Item
    prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
    boolean
    C0678222 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C2148528 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    C1514457 (UMLS CUI [3])
    C1514457 (UMLS CUI [4,1])
    C0444956 (UMLS CUI [4,2])
    C1504389 (UMLS CUI [5])
    C0005961 (UMLS CUI [6])
    Excision biopsy
    Item
    excisional biopsy performed prior to enrollment
    boolean
    C0184921 (UMLS CUI [1])
    Blood Coagulation Disorder Uncontrolled
    Item
    uncontrolled coagulopathy
    boolean
    C0005779 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    upper gastrointestinal tract Integrity Physical Lacking | Malabsorption Syndrome
    Item
    lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
    boolean
    C1268997 (UMLS CUI [1,1])
    C1947912 (UMLS CUI [1,2])
    C0205485 (UMLS CUI [1,3])
    C0332268 (UMLS CUI [1,4])
    C0024523 (UMLS CUI [2])

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