PARC-ITP study - Frequently asked questions

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Our Ethics Committee/Institutional Review Board is worried about blood sampling. How can the ethical issues be addressed?Our Ethics Committee/Institutional Review Board is worried about blood sampling. How can the ethical issues be addressed?
The PARC-ITP study has been amended in 2005 to allow the collection of blood samples from ITP patients and controls. Genetic analysis will concern DNA only. The aim is to obtain DNA profiles for patients with ITP. Correlation analysis will be performed with demographic and clinical parameters from the PARC-ITP registry (database). Genetic analyses will be done solely for the purpose of finding genetic markers in relation to ITP. They will be performed when sufficient blood samples have been collected - which may take some time - , at 2-3 centers of excellence, taking newest and promising methodologies in this developing field into consideration. Blood will be stored centrally in Basel, Switzerland and shipping will be organized and covered by ICIS. To ensure confidentiality and safety, both patient data and blood samples will be handled anonymized. The database is password-protected. Names and addresses of patients will not be accessible to the ICIS study personnel. Informed consent of all ITP patients and controls will be obtained before collection. Because results of the individual ITP patients are not expected to be meaningful in themselves, they will not be handed back to the physician or patient. Details may be found in the PARC-ITP study protocol (Version 2.0, 2005-2-25) which has been approved by the Swiss Ethics Committee in Basel in May 2005, and in the overview in the 'Summary of the Amendment'.
If I cannot provide blood samples, can I still participate in the PARC-ITP registry?
Collecting blood samples is voluntary and does not exclude from study participation.
How can I submit patient data?
Before signing up for participation, you must seek approval of the PARC-ITP study protocol for your center by your local/national Institutional Review Board and/or Ethics Committee according to the legislation of your country/province. Once you have received approval, please sign up at www.parc-itp.net or contact us at info@parc-itp.net. To submit patient data please read our 'Guide' (11 pages).
Can referred patients be included in the study?
In cases where a prospective collection of data is not possible, i.e. if your clinic sees mainly referred patients, data may be submitted retrospectively for up to 12 months after initial diagnosis.
Will my center be reimbursed?
All centers participating in the PARC-ITP study will do so at their own expenses. If you are collecting blood samples from ITP patients and controls, ICIS will provide shipping material, organize shipping and cover the expenses.
Why is data of newly diagnosed ITP patients being collected in the PARC-ITP database, if this is a registry on chronic ITP?
Data of the first 6 months after diagnosis may be helpful in determining factors relating to chronic ITP and secondary ITP. One of the primary objectives of the PARC-ITP study is to determine new patient selection criteria for future trials. Subsequent side studies will address more specific issues of ITP. Therefore, it is important to collect data starting at the initial diagnosis of ITP.
If I am already participating in another ICIS project, can I sign up for the PARC-ITP study?
If you are a physician participating in Registry II and you are interested in participating in the PARC-ITP registry, please continue to send in the follow-up forms of Registry II patients for 24 months. All newly diagnosed ITP patients may be registered prospectively in the PARC-ITP database, which means that some centers will possibly be submitting patient data to both registries, until the follow-ups of Registry II are completed. No data of the same patient should be entered to both Registry II and PARC-ITP. New centers are encouraged to participate in the PARC-ITP registry. Participating in the Splenectomy Registry as well as in the PARC-ITP registry is possible, i.e. a patient can be registered simultaneously in both registries.
Where can I download the PARC-ITP study protocol and forms?
To download the PARC-ITP study protocol and forms, as well as other important documents, please go to click here. If you have trouble downloading a document, please contact info@parc-itp.net.

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