0 Ratings
ID

18132

Description

MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00606866

Link

https://clinicaltrials.gov/show/NCT00606866

Keywords

Versions (1)
  1. 10/21/16 10/21/16 -
Uploaded on

October 21, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    English

    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically or cytologically confirmed metastatic clear cell renal cell cancer;
    Description

    Clear Cell Renal Cell Carcinoma Metastatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0279702
    UMLS CUI [1,2]
    C0036525
    at least one lesion that can be accurately measured in at least one dimension;
    Description

    Measurable Disease Linear Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0205132
    UMLS CUI [1,3]
    C1265611
    patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
    Description

    Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1152564
    UMLS CUI [1,2]
    C0521124
    UMLS CUI [1,3]
    C0006826
    UMLS CUI [2,1]
    C2984329
    UMLS CUI [2,2]
    C0243077
    age 18 and older;
    Description

    Age

    Data type

    boolean

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

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
    Description

    Blood pressure finding Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1271104
    UMLS CUI [1,2]
    C1265611
    normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
    Description

    organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201976
    women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
    Description

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0700589
    ability to understand and the willingness to sign a written informed consent document.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    chemotherapy or radiotherapy within 4 weeks prior to entering the study;
    Description

    Chemotherapy | Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    any other investigational agents;
    Description

    Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    known brain metastases;
    Description

    Metastatic malignant neoplasm to brain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
    Description

    Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0009450
    UMLS CUI [3]
    C0742758
    UMLS CUI [4]
    C0002965
    UMLS CUI [5]
    C0003811
    UMLS CUI [6,1]
    C0004936
    UMLS CUI [6,2]
    C1321605
    UMLS CUI [6,3]
    C0439801
    UMLS CUI [7,1]
    C0748872
    UMLS CUI [7,2]
    C1321605
    UMLS CUI [7,3]
    C0439801
    pregnancy.
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Clear Cell Renal Cell Carcinoma Metastatic
    Item
    histologically or cytologically confirmed metastatic clear cell renal cell cancer;
    boolean
    C0279702 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    Measurable Disease Linear Quantity
    Item
    at least one lesion that can be accurately measured in at least one dimension;
    boolean
    C1513041 (UMLS CUI [1,1])
    C0205132 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors
    Item
    patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
    boolean
    C1152564 (UMLS CUI [1,1])
    C0521124 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [1,3])
    C2984329 (UMLS CUI [2,1])
    C0243077 (UMLS CUI [2,2])
    Age
    Item
    age 18 and older;
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0-2;
    boolean
    C1520224 (UMLS CUI [1])
    Blood pressure finding Quantity
    Item
    blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
    boolean
    C1271104 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
    Item
    normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
    boolean
    C0678852 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201976 (UMLS CUI [4])
    Childbearing Potential Contraceptive methods | Gender Contraceptive methods
    Item
    women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Informed Consent
    Item
    ability to understand and the willingness to sign a written informed consent document.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy | Therapeutic radiology procedure
    Item
    chemotherapy or radiotherapy within 4 weeks prior to entering the study;
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    Investigational New Drugs
    Item
    any other investigational agents;
    boolean
    C0013230 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain
    Item
    known brain metastases;
    boolean
    C0220650 (UMLS CUI [1])
    Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
    Item
    uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2])
    C0742758 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0003811 (UMLS CUI [5])
    C0004936 (UMLS CUI [6,1])
    C1321605 (UMLS CUI [6,2])
    C0439801 (UMLS CUI [6,3])
    C0748872 (UMLS CUI [7,1])
    C1321605 (UMLS CUI [7,2])
    C0439801 (UMLS CUI [7,3])
    Pregnancy
    Item
    pregnancy.
    boolean
    C0032961 (UMLS CUI [1])
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