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ID

15614

Description

EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02154399

Link

https://clinicaltrials.gov/show/NCT02154399

Keywords

  1. 6/5/16 6/5/16 -
Uploaded on

June 5, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Stage IA Non-Small Cell Lung Carcinoma NCT02154399

    Eligibility Stage IA Non-Small Cell Lung Carcinoma NCT02154399

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (nsclc) must be estimated by their physician to have at least 75% probability of having nsclc; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a bayesian model
    Description

    non-small cell lung cancer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007131 (Non-Small Cell Lung Carcinoma)
    SNOMED
    254637007
    clinical or pathologic stage i to iii; patients in whom pre-surgical staging has not definitively establish stage iv disease are eligible
    Description

    clinical or pathologic stage i to iii

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027646 (Diagnostic Neoplasm Staging)
    SNOMED
    258232002
    tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (ct) scan and must be included in the planned surgical biopsy or resection
    Description

    tumor mass size

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3273930 (Tumor Mass)
    UMLS CUI [1,2]
    C0205099 (Central)
    SNOMED
    26216008
    patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure
    Description

    surgical staging

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    performance status 0-2
    Description

    performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    bilirubin within normal limits
    Description

    bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005437 (Bilirubin)
    SNOMED
    79706000
    LOINC
    LP15448-1
    creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 ml/min/m^2 (ef5 is primarily excreted via the kidney)
    Description

    creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010294 (creatinine)
    SNOMED
    15373003
    UMLS CUI [2]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    white blood cell (wbc) > 2000/mm^3
    Description

    WBC

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    platelets > 100,000/mm^3
    Description

    platelets

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ef5
    Description

    pregnancy or breast feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    allergy to iv contrast dye
    Description

    allergy to iv contrast dye

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0742795 (contrast dye)
    history of grade iii or iv peripheral neuropathy as defined by the national cancer institute (nci) common terminology criteria (ctc)
    Description

    peripheral neuropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031117 (Peripheral Neuropathy)

    Similar models

    Eligibility Stage IA Non-Small Cell Lung Carcinoma NCT02154399

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    non-small cell lung cancer
    Item
    known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (nsclc) must be estimated by their physician to have at least 75% probability of having nsclc; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a bayesian model
    boolean
    C0007131 (UMLS CUI [1])
    clinical or pathologic stage i to iii
    Item
    clinical or pathologic stage i to iii; patients in whom pre-surgical staging has not definitively establish stage iv disease are eligible
    boolean
    C0027646 (UMLS CUI [1])
    tumor mass size
    Item
    tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (ct) scan and must be included in the planned surgical biopsy or resection
    boolean
    C3273930 (UMLS CUI [1,1])
    C0205099 (UMLS CUI [1,2])
    surgical staging
    Item
    patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure
    boolean
    C0543467 (UMLS CUI [1])
    performance status
    Item
    performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    bilirubin
    Item
    bilirubin within normal limits
    boolean
    C0005437 (UMLS CUI [1])
    creatinine
    Item
    creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 ml/min/m^2 (ef5 is primarily excreted via the kidney)
    boolean
    C0010294 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    WBC
    Item
    white blood cell (wbc) > 2000/mm^3
    boolean
    C0023508 (UMLS CUI [1])
    platelets
    Item
    platelets > 100,000/mm^3
    boolean
    C0005821 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnancy or breast feeding
    Item
    pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ef5
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    allergy to iv contrast dye
    Item
    allergy to iv contrast dye
    boolean
    C0020517 (UMLS CUI [1,1])
    C0742795 (UMLS CUI [1,2])
    peripheral neuropathy
    Item
    history of grade iii or iv peripheral neuropathy as defined by the national cancer institute (nci) common terminology criteria (ctc)
    boolean
    C0031117 (UMLS CUI [1])

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