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TAKING PART IN PSORIASIS RESEARCH

STUDY TITLE: Discovery and functional investigation of susceptibility alleles to pustular psoriasis and correlation with clinical features

You are being invited to take part in a research study. Before you decide it is important to understand why the research is being done and what it will involve. You can participate in the in the institution that participates in ERASPEN in your homecountry. Please ask the study doctor or nurse if there is anything that is not clear or if you would like more information. 

Current therapies for pustular and other rare forms of psoriasis do not cure the disease and may cause significant side­ effects, partly because the causes of this condition are not fully understood. With this study, we seek to identify the genes that cause these forms of psoriasis and understand how they alter immune responses to result in disease. This knowledge will help to guide the development of more effective treatments.  

You have been invited to take part because you have a rare and pustular form of psoriasis. 

You will not receive any financial benefits for taking part in this study and the results of the study will not be of any direct clinical benefit to you. However, by taking part in this study you will be providing vital information to the research team which we hope will lead to better treatments for people with psoriasis.

There are no important risks to taking part in this study. Blood tests can sometimes be uncomfortable and cause bruising at the site. However we will try to take any research blood samples from you when you are having your routine blood tests taken to minimise discomfort and our experienced staff will take all safety measures to reduce complications from the procedures performed. 

No. Taking part is entirely voluntary and your clinical care will not be affected by your decision to participate or not participate in this study.

You will be asked to sign a consent form

In order to participate in the study we will ask you to sign a consent form. A study doctor or nurse will go through the consent procedure with you and explain the study in detail.

You will be asked to provide clinical information

We need to collect clinical information from you regarding your psoriasis and your previous/current treatments. We also need to know about your general health, ethnic origin, family history of psoriasis, and whether you are taking any other medication. To minimise the amount of time you need to spend while participating in this study, with your permission, data will be collected from your medical records by the research nurse or study doctor, wherever possible. The study nurse will also measure your height, waist and weight.

You will be asked to provide a sample of your blood

You will be asked to donate one sample of blood (6 teaspoons i.e. 30ml) to look at your genes (often referred to as "DNA"). We may also look at RNA, which is related to DNA. Occasionally when blood samples cannot be collected, we can isolate DNA from saliva, in which case you will asked to spit 2ml (approximately half a teaspoon) into a plastic pot. This may be done during your clinical visit or a saliva collection kit may be sent to your home with a pre-paid return envelope.

You may be asked to make an additional visit to clinic

On the basis of the analysis of your DNA, we may invite you back to clinic to provide a skin biopsy/hair plucks. These are valuable samples that will help to determine the function of the genes contributing to psoriasis. This is an optional request. You can still take part in the study if you don't wish to be contacted for future investigations and it will not impact your clinical care. 

Yes. You will be assigned an anonymised study number, which will be used for all study-related material (including data). No person-identifiable information will be used in any correspondence. Only the study team will know which anonymised number relates to you. 

All your data will be stored in accordance with the International Conference on Harmonisation for Good Clinical Practice. Your data will held on a secure, anonymised, confidential database for the purposes of this study, which only the Chief Investigator for this study, Professor Jonathan Barker, members of the research team and approved regulatory personnel will have access to.
Our team collaborate on psoriasis research throughout the world. By signing the consent form, you are agreeing that your study data can be shared with research collaborators and industry partners who may be located outside of the country or region (e.g. European Union) in which you live. 

All samples will be stored securely in accordance with national and local guidelines and will only be used for scientific research related to psoriasis. We may culture cells from your blood/skin for the purposes of the study; you will not have any financial benefits or rights over these samples. We plan to store your samples for as long as this and future studies of psoriasis continue at the study site.

Depending on your homecountry, the clinical trial protocol's sponsor and the location of sample storage will normally be at the institution that participates in ERASPEN.

As an example:

In Zurich, you would be offered participation in the NEUTROGENE trial (NCT01952275, KEK 2013-0497) and your samples stored in the Dermatology Biobank at University Hospital of Zurich. 

In London, you would participate in a study at Guy's Hospital, London and we will store your samples anonymously for future research into skin disease in a research bio-bank at St. John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Trust: Ethics Approval Ref: 07/H0712/106; HTA License number 12521. 

We will use the samples you provide to look at genes related to our psoriasis research only. We will not use your DNA for any tests to learn about your risk of developing any other disease. 

When the study has been completed we will aim to publish the results in scientific journals/publications.  Please let us know if you wish to be informed of the publication of the study and we will aim to keep you fully informed.  You will not be identified in any publication.

Please contact the study's local chief investigator as indicated in the patient information leaflet that you received together with the informed consent form.

If at any time you wish to withdraw from the study we will provide you with a form to complete and return to us asking us to destroy your samples and withdraw you from the study. Your samples, including your DNA, will be removed from storage and destroyed and any research data we have collected about you will not be used in this study. Your participation is voluntary. None of these actions will affect your future treatment.

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions.
Please contact the study's local chief investigator as indicated in the patient information leaflet that you received together with the informed consent. Alternatively, you can write an email to alexander.navarini@usz.ch who will forward your email to your local chief investigator. 

If you have understood all the information above and wish to participate in the study you will be asked to sign a Consent Form. You should keep a copy of this Information Sheet for yourself.