0 Ratings

ID

16326

Description

Gemcitabine + Carboplatin in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00450762

Link

https://clinicaltrials.gov/show/NCT00450762

Keywords

  1. 7/11/16 7/11/16 -
Uploaded on

July 11, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00450762

    Eligibility Breast Cancer NCT00450762

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically confirmed metastatic breast cancer
    Description

    metastatic breast cancer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278488 (Carcinoma breast stage IV)
    all patients were required to give written informed consent.
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
    Description

    Previous treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2114510 (previous therapy)
    patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
    Description

    Measurable lesion outside a previous radiation port

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041 (Measurable Disease)
    UMLS CUI [1,2]
    C1282506 (Metastasis from malignant tumor of breast)
    SNOMED
    315004001
    age ≥ 18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    karnofsky performance status ≥ 70 %
    Description

    karnofsky performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    minimal life expectancy of 12 weeks
    Description

    Life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    adequate haematological, renal, cardiac and hepatic function:
    Description

    Organ function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    1. leukocyte count ≥ 3.0 x 109/l
    Description

    leukocyte count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    2. absolute neutrophil count ≥ 2.0 x 109/l
    Description

    absolute neutrophil count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    3. platelet count ≥ 100 x 109/l
    Description

    platelet count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    4. haemoglobin ≥ 8 g/dl
    Description

    haemoglobin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
    Description

    total serum bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [2]
    C0494165 (Secondary malignant neoplasm of liver)
    SNOMED
    94381002
    6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
    Description

    transaminases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002594 (Transaminases)
    SNOMED
    130093006
    UMLS CUI [2]
    C0494165 (Secondary malignant neoplasm of liver)
    SNOMED
    94381002
    7. alkaline phosphatase level ≤ 2.5 x uln
    Description

    alkaline phosphatase level

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1272113 (Plasma alkaline phosphatase level)
    SNOMED
    390962007
    8. creatinine clearance was required to exceed 60 ml/min.
    Description

    creatinine clearance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    prior treatment with gemcitabine or platinum agents
    Description

    Gemcitabine or platinum agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0045093 (gemcitabine)
    SNOMED
    108811008
    UMLS CUI [2]
    C2266918 (Platinum-based Drug [EPC])
    inadequate creatinine clearance (< 60 ml/min)
    Description

    creatinine clearance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    only bone metastases
    Description

    bone metastases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0153690 (Secondary malignant neoplasm of bone)
    SNOMED
    94222008
    symptomatic brain metastases
    Description

    brain metastases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    UMLS CUI [1,2]
    C0231220 (Symptomatic)
    SNOMED
    264931009
    LOINC
    LA17766-9
    women who are pregnant, lactating or refuse effective contraception
    Description

    women who are pregnant, lactating or refuse effective contraception

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0425965 (Possible pregnancy (finding))
    SNOMED
    102874004
    UMLS CUI [2]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [3]
    C2828358 (Lactating (finding))
    secondary malignancy
    Description

    secondary malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3266877 (Secondary Malignant Neoplasm)
    history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
    Description

    another primary malignant disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0751623 (Second Primary Cancers)
    SNOMED
    878806005
    active infection
    Description

    active infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C0205177 (Active)
    SNOMED
    55561003
    LOINC
    LA16666-2
    any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
    Description

    comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488 (Comorbidity)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9

    Similar models

    Eligibility Breast Cancer NCT00450762

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    metastatic breast cancer
    Item
    histologically confirmed metastatic breast cancer
    boolean
    C0278488 (UMLS CUI [1])
    informed consent
    Item
    all patients were required to give written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Previous treatment
    Item
    prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
    boolean
    C2114510 (UMLS CUI [1])
    Measurable lesion outside a previous radiation port
    Item
    patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1282506 (UMLS CUI [1,2])
    Age
    Item
    age ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    karnofsky performance status
    Item
    karnofsky performance status ≥ 70 %
    boolean
    C0206065 (UMLS CUI [1])
    Life expectancy
    Item
    minimal life expectancy of 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Organ function
    Item
    adequate haematological, renal, cardiac and hepatic function:
    boolean
    C0678852 (UMLS CUI [1])
    leukocyte count
    Item
    1. leukocyte count ≥ 3.0 x 109/l
    boolean
    C0023508 (UMLS CUI [1])
    absolute neutrophil count
    Item
    2. absolute neutrophil count ≥ 2.0 x 109/l
    boolean
    C0948762 (UMLS CUI [1])
    platelet count
    Item
    3. platelet count ≥ 100 x 109/l
    boolean
    C0005821 (UMLS CUI [1])
    haemoglobin
    Item
    4. haemoglobin ≥ 8 g/dl
    boolean
    C0518015 (UMLS CUI [1])
    total serum bilirubin
    Item
    5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
    boolean
    C1278039 (UMLS CUI [1])
    C0494165 (UMLS CUI [2])
    transaminases
    Item
    6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
    boolean
    C0002594 (UMLS CUI [1])
    C0494165 (UMLS CUI [2])
    alkaline phosphatase level
    Item
    7. alkaline phosphatase level ≤ 2.5 x uln
    boolean
    C1272113 (UMLS CUI [1])
    creatinine clearance
    Item
    8. creatinine clearance was required to exceed 60 ml/min.
    boolean
    C0373595 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Gemcitabine or platinum agents
    Item
    prior treatment with gemcitabine or platinum agents
    boolean
    C0045093 (UMLS CUI [1])
    C2266918 (UMLS CUI [2])
    creatinine clearance
    Item
    inadequate creatinine clearance (< 60 ml/min)
    boolean
    C0373595 (UMLS CUI [1])
    bone metastases
    Item
    only bone metastases
    boolean
    C0153690 (UMLS CUI [1])
    brain metastases
    Item
    symptomatic brain metastases
    boolean
    C0220650 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    women who are pregnant, lactating or refuse effective contraception
    Item
    women who are pregnant, lactating or refuse effective contraception
    boolean
    C0425965 (UMLS CUI [1])
    C0549206 (UMLS CUI [2])
    C2828358 (UMLS CUI [3])
    secondary malignancy
    Item
    secondary malignancy
    boolean
    C3266877 (UMLS CUI [1])
    another primary malignant disease
    Item
    history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
    boolean
    C0751623 (UMLS CUI [1])
    active infection
    Item
    active infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    comorbidity
    Item
    any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])

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