Molecular Monitoring Survey EUREKA

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

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

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

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

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

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

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

Description

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

Data type

integer

Alias

UMLS CUI [1]

C0085546

Description

For any further questions please consult your treating physician.

Data type

integer

Alias

UMLS CUI [1]

C0337611

Description

Name, Surname of patient: ________________________________________ Date of birth: ___. ___. _____ Hereby I confirm my participation at the EUREKA-survey. Mr. /Mrs. (Dr. med.) ______________________________________________ has clearly and understandably explained me the objectives, scope and rationale of the EUREKA-survey as well as the relevant data protection rights. I have read and understood the patient information and informed consent form. My treating physician has understandably und sufficiently answered my questions. I have been given a sufficient amount of time to ask questions and to make a decision. I have been informed that my participation at the survey is voluntary, that it does not affect my treatment and that the survey is a mere documentation project with accompanying biospecimen collection and that no requirements concerning my treatment are made. I reserve the right to withdraw my consent at any time without notice for any reason, without my incurring therefrom penalties or loss of privileges. In case of consent withdrawal my data will be deleted and my biospecimen destroyed as good as possible. I have been informed that that it is not possible to return my biospecimen from the biobank where it is stored. I agree that my personal treatment data that is collected in the context of the study is saved, analyzed and forwarded to the CML study office at the Jena University Hospital. I also agree that my pseudonymized biospecimen (by usage of a code that does not allow any traces to my person) that are used for the measurement of the residual disease can be stored infinitely at a laboratory and if needed used for testing new methods for the measurement of the residual disease. My data and the analysis of the results of the measurement of the residual disease can improve knowledge about the creation and progression of cancer and other diseases, the response of the treatment, predictability of the outcome and possibly to the development of new therapies and diagnostics. I have been informed that my participation at the survey and the biobank involves no personal advantage or financial benefit and that I will not be informed about the research findings.

Data type

integer

Alias

UMLS CUI [1]

C0021430