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ID

31547

Descrição

A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect); ODM derived from: https://clinicaltrials.gov/show/NCT01014065 Sponsor: AHS Cancer Control Alberta Collaborator: Cross Cancer Institute Information provided by (Responsible Party): AHS Cancer Control Alberta Principal Investigator: Mark Haykowsky, PhD University of Alberta

Link

https://clinicaltrials.gov/show/NCT01014065

Palavras-chave

Versões (1)
  1. 03/09/2018 03/09/2018 -
Titular dos direitos

AHS Cancer Control Alberta

Transferido a

3 de setembro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    Eligibility Renal Cell Carcinoma NCT01014065

    Inglês

    Eligibility Renal Cell Carcinoma NCT01014065

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologic diagnosis of metastatic renal cell carcinoma
    Descrição

    Histological confirmation of metastatic renal cell carcinoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0449575 (Histological finding)
    SNOMED
    263540008
    UMLS CUI [1,2]
    C0278678 (Metastatic Renal Cell Cancer)
    eligible to receive first-line sunitinib
    Descrição

    Eligibility to receive first-line sunitinib

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1548635 (Eligible)
    UMLS CUI [1,2]
    C1708063 (First line treatment)
    SNOMED
    708255002
    UMLS CUI [1,3]
    C1176020 (sunitinib)
    SNOMED
    421192001
    willingness to attend cross cancer institute and university of alberta for study-related assessments
    Descrição

    Attendance at the cross cancer institute and university of alberta

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2825164 (Study Site)
    UMLS CUI [1,2]
    C2827364 (Attendance)
    UMLS CUI [1,3]
    C0600109 (Willing)
    SNOMED
    225466006
    karnofsky performance status (kps)82 ≥ 70
    Descrição

    Karnofsky performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    age ≥ 18 years of age
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    adequate creatinine clearance to receive gadolinium
    Descrição

    Adequate creatinine clearance to receive gadolinium

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0016911 (gadolinium)
    SNOMED
    58281002
    UMLS CUI [1,2]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    all patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to cpet;
    Descrição

    Bone metastases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0153690 (Secondary malignant neoplasm of bone)
    SNOMED
    94222008
    fluent in english language
    Descrição

    Fluency in English language

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0564241 (Able to speak fluently)
    SNOMED
    286400000
    UMLS CUI [1,2]
    C0376245 (English Language)
    SNOMED
    297487008
    LOINC
    LA43-5
    no contraindication to mri or other concern eg., metallic implants, claustrophobia
    Descrição

    Contraindications to mri

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0024485 (Magnetic Resonance Imaging)
    SNOMED
    312250003
    LOINC
    LP57602-2
    UMLS CUI [1,2]
    C0522473 (Contraindication)
    SNOMED
    103306004
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    prior systemic therapy for mrcc
    Descrição

    Prior systemic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1515119 (Systemic Therapy)
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C0278678 (Metastatic Renal Cell Cancer)
    documented history of major cardiac event in last year i.e. mi, unstable angina, cabg, symptomatic chf, cva or tia, or pulmonary embolism
    Descrição

    History of major cardiac event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1320716 (Cardiovascular event)
    SNOMED
    405617006
    UMLS CUI [1,2]
    C0205164 (Major)
    SNOMED
    255603008
    LOINC
    LA29634-5
    UMLS CUI [2]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [3]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    UMLS CUI [4]
    C1275842 (History of coronary artery bypass grafting)
    SNOMED
    399261000
    UMLS CUI [5]
    C1275835 (History of myocardial infarction)
    SNOMED
    399211009
    LOINC
    LA20365-5
    UMLS CUI [6,1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [6,2]
    C0231220 (Symptomatic)
    SNOMED
    264931009
    LOINC
    LA17766-9
    UMLS CUI [7]
    C0038454 (Cerebrovascular accident)
    SNOMED
    230690007
    LOINC
    MTHU020801
    UMLS CUI [8]
    C0455536 (History of transient ischemic attack)
    SNOMED
    161511000
    UMLS CUI [9]
    C0034065 (Pulmonary Embolism)
    SNOMED
    59282003
    LOINC
    LP90124-6
    pregnancy
    Descrição

    Pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate
    Descrição

    Concomitant severe medical condition or abnormality

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    unstable brain metastases
    Descrição

    Brain metastasis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377 (CNS metastases)
    SNOMED
    94243009
    UMLS CUI [1,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
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    Similar models

    Eligibility Renal Cell Carcinoma NCT01014065

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Histological confirmation of metastatic renal cell carcinoma
    Item
    histologic diagnosis of metastatic renal cell carcinoma
    boolean
    C0449575 (UMLS CUI [1,1])
    C0278678 (UMLS CUI [1,2])
    Eligibility to receive first-line sunitinib
    Item
    eligible to receive first-line sunitinib
    boolean
    C1548635 (UMLS CUI [1,1])
    C1708063 (UMLS CUI [1,2])
    C1176020 (UMLS CUI [1,3])
    Attendance at the cross cancer institute and university of alberta
    Item
    willingness to attend cross cancer institute and university of alberta for study-related assessments
    boolean
    C2825164 (UMLS CUI [1,1])
    C2827364 (UMLS CUI [1,2])
    C0600109 (UMLS CUI [1,3])
    Karnofsky performance status
    Item
    karnofsky performance status (kps)82 ≥ 70
    boolean
    C0206065 (UMLS CUI [1])
    Age
    Item
    age ≥ 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Adequate creatinine clearance to receive gadolinium
    Item
    adequate creatinine clearance to receive gadolinium
    boolean
    C0016911 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    Bone metastases
    Item
    all patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to cpet;
    boolean
    C0153690 (UMLS CUI [1])
    Fluency in English language
    Item
    fluent in english language
    boolean
    C0564241 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    Contraindications to mri
    Item
    no contraindication to mri or other concern eg., metallic implants, claustrophobia
    boolean
    C0024485 (UMLS CUI [1,1])
    C0522473 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Prior systemic therapy
    Item
    prior systemic therapy for mrcc
    boolean
    C1515119 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0278678 (UMLS CUI [1,3])
    History of major cardiac event
    Item
    documented history of major cardiac event in last year i.e. mi, unstable angina, cabg, symptomatic chf, cva or tia, or pulmonary embolism
    boolean
    C1320716 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C1275842 (UMLS CUI [4])
    C1275835 (UMLS CUI [5])
    C0018802 (UMLS CUI [6,1])
    C0231220 (UMLS CUI [6,2])
    C0038454 (UMLS CUI [7])
    C0455536 (UMLS CUI [8])
    C0034065 (UMLS CUI [9])
    Pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Concomitant severe medical condition or abnormality
    Item
    other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Brain metastasis
    Item
    unstable brain metastases
    boolean
    C0686377 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
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