ID

12750

Description

EUropean survey on the assessment of deep molecular REsponse in chronic phase CML patients after at least two years of therapy with tyrosine KinAse inhibitors - major component of the Path to Cure Pillar of EUTOS III. ODM derived from: http://www.eutos.org/content/path_to_cure/eureka/index_eng.html

Link

http://www.eutos.org/content/path_to_cure/eureka/index_eng.html

Keywords

  1. 12/16/15 12/16/15 -
  2. 12/19/15 12/19/15 -
  3. 12/19/15 12/19/15 -
  4. 12/20/15 12/20/15 -
  5. 1/3/16 1/3/16 -
Uploaded on

December 19, 2015

DOI

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License

Creative Commons BY-NC 3.0

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    Molecular Monitoring Survey EUREKA

    Informed Consent Form

    1. StudyEvent: ODM
      1. Informed Consent Form
    Patient Information
    Description

    Patient Information

    Patient information
    Description

    Dear patients, As your health care provider we ask you to consent to participate at the European survey on the assessment of deep molecular Response in chronic phase CML patients after at least two years of therapy with tyrosine kinase inhibitors (EUREKA-Survey). This informed consent form shall provide you the necessary information on deciding to participate at the EUREKA survey. Your treating physician has thoroughly informed you that you have been afflicted with CML. You have also been taught about the importance of the molecular response in the context of CML management and prognosis, accurate and reproducible molecular analyses of the peripheral blood are essential for monitoring the therapy effectiveness. Measurement of minimal residual disease has been improved considerably over the last couple of years. Assessing the significance of the findings according an international standardized method is very important.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1955348
    Aim of the EUREKA-survey
    Description

    Aim of the EUREKA-survey

    Study aim
    Description

    In an effort to constantly improving the treatment of CML, the EUREKA-survey is collecting and assessing medical data and molecular results of the measurement of the residual disease independent of a patients participation in a therapy study. The laboratories providing that particular data have special experience and fulfill certain quality assurance procedures. The data assessment shall give new insights into a European-wide availability of the standardized measurement of deep molecular response of CML. The results will be available for all CML patients that have been treated with tyrosine kinase inhibitor for at least two years. Biospecimen for the measurement of the residual disease (deoxyribonucleic acid, DNA; Ribonucleic acid, RNA) will be stored for a potential future reassessment with further developed methods.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1947946
    UMLS CUI [1,2]
    C0008972
    Process of data collection
    Description

    Process of data collection

    Process of data collection
    Description

    The survey consist of a data acquisition alongside biomaterial collection. You will be fully informed about the therapy of your disease through your treating physician. Your treating physician will send survey documentation sheets comprising information about your disease, course of therapy and the result of the latest examination of the residual disease and your blood for the most recent analysis to the examination laboratory. There the data plus the results of the measurement will be entered into an electronic data acquisition system

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0262727
    Process of biomaterial collection
    Description

    Process of biomaterial collection

    Process of biospecimen collection
    Description

    The measurement of the residual disease during a CML therapy is a routine procedure. Therefore the EUREKA-survey does not require additional taking of blood samples. 20 ml. of peripheral blood will be sent to a national reference laboratory for the measurement of deep molecular response of CML. The biospecimen will be stored at the reference laboratory for an undefined period and if necessary used for scientific research purposes for further research into CML or for applying new methods of measurement of residual disease. All research projects where biospecimen from the EUREKA-biobank is used are examined and approved by the scientific panel of the EUREKA-survey. Furthermore all research projects have to be approved previously by an ethic commission.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347027
    Potential risks and benefits
    Description

    Potential risks and benefits

    Potential risks and benefits
    Description

    By providing your informed consent to data collection and biospecimen collection you can contribute to the development and distribution of new standardized detection methods. By doing so you also contribute to further improving the medical care of CML: By participating at the biobank you will receive the result of the measurement of residual disease from a laboratory that is participating at international studies on standardization and quality control. Your participation does not contain a direct personal benefit for your treatment. As the EUREKA-survey is a mere data collection survey and concomitantly biospecimen collection your participation does not involve any additional risk.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0687742
    Information of data security
    Description

    Information of data security

    Information on data security
    Description

    In the context of the EUREKA-survey your personal and medical data will be anonymized and transferred to the respective lavatory from where it then will be further sent to the CML-study coordination office in Jena. The biospecimen are exclusively stored in a pseudonymized way by using a number code that does not allow any trace to your personal identification. Your data is treated confidentially and will not be passed on to third parties at any time. All personnel involved are subject to professional secrecy and your data underlies professional discretion and data protection. Analysis of the data collected are made exclusively pseudonymous. In case of a publication of study results (e.g. at conferences or in professional journals) no names will be stated and your personal identification will not be traceable. Even a disclosure of medical data or biospecimen to a third party (e.g. cooperating scientists) for scientific projects will be made pseudonymously. Your personal data will under no circumstances be disclosed to any third party. The collected data and biospecimen will be saved and stored indefinitely. Single specimen of the biobank can be destroyed in case they are not needed anymore. By providing your informed consent you agree to processing your personal data and biospecimen as descried above.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0086100
    Voluntariness and withdrawl of consent
    Description

    Voluntariness and withdrawl of consent

    Voluntariness and withdrawl of consent
    Description

    Your participation at the EURKEA-survey and biobank is voluntarily. You can withdraw your consent at any time without stating a reason without penalty or loss of privilege. In that case no further data from you will be collected, medical data already collected will be deleted and your biospecimen will be destroyed.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0680274
    UMLS CUI [1,2]
    C0586888
    Further information
    Description

    Further information

    Furhter information
    Description

    The EURKEA-survey has been approved by the competent ethics commission.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0085546

    Similar models

    Informed Consent Form

    1. StudyEvent: ODM
      1. Informed Consent Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient Information
    Patient information
    Item
    Patient information
    integer
    C1955348 (UMLS CUI [1])
    Item Group
    Aim of the EUREKA-survey
    Study aim
    Item
    Study aim
    integer
    C1947946 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Item Group
    Process of data collection
    Process of data collection
    Item
    Process of data collection
    integer
    C0262727 (UMLS CUI [1])
    Item Group
    Process of biomaterial collection
    Process of biospecimen collection
    Item
    Process of biospecimen collection
    integer
    C2347027 (UMLS CUI [1])
    Item Group
    Potential risks and benefits
    Potential risks and benefits
    Item
    Potential risks and benefits
    integer
    C0687742 (UMLS CUI [1])
    Item Group
    Information of data security
    Information on data security
    Item
    Information on data security
    integer
    C0086100 (UMLS CUI [1])
    Item Group
    Voluntariness and withdrawl of consent
    Voluntariness and withdrawl of consent
    Item
    Voluntariness and withdrawl of consent
    integer
    C0680274 (UMLS CUI [1,1])
    C0586888 (UMLS CUI [1,2])
    Item Group
    Further information
    Furhter information
    Item
    Furhter information
    integer
    C0085546 (UMLS CUI [1])

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