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Investigating skin metabolites as a new way to diagnose Parkinson’s disease

This is a research study to investigate the chemicals known as metabolites found on the skin of people with Parkinson’s disease (PD).

Investigating skin metabolites as a new way to diagnose Parkinson’s disease

We would like to invite you to take part in our research study. To help you decide, we have provided information on why we are doing the research and what it would involve for you.

  • Part 1 tells you the background and purpose of the study and what will happen to you if you take part.
  • Part 2 gives you more detailed information about the conduct of the study.

Please take time to read this information carefully, and ask us if there is anything that is not clear, or if you want more information.

PART ONE

 What is the purpose of the study?

This is a research study to investigate the chemicals known as metabolites found on the skin of people with Parkinson’s disease (PD). A significant number of studies have found that people with PD exhibit a number of benign symptoms years before the first signs of movement problems. The purpose of this study is to determine if we can identify changes in the skin of people with PD that can be used for early diagnosis and provide a non-invasive method to follow progression.

The skin contains sebaceous glands which are glands that produce an oily substance. There is evidence in the scientific literature that the oily substance produced by the sebaceous glands of people with PD is altered, and we have identified and tested a woman that can detect PD by body odour alone. We have analysed some of the skin swabs in a chemistry laboratory. Using a technique called mass spectrometry, the chemistry laboratory were able to look at all the chemicals in the gauze swab and show that there was a difference between PD subjects and subjects without PD. We hope that we will be able to develop a very simple test to diagnose PD by looking at the chemicals present on the skin.

So far we have only tested samples from a small number of people. We now want to study a much larger number of people, including those with and without PD. We also want to study PD participants who are not yet on PD medication. We will use three different ways to study the chemicals on the skin. Firstly we will be rubbing a gauze swab over the skin; secondly we will be putting a sticky film similar to sellotape on the skin; thirdly we will be putting a small tube on the skin to collect the small chemicals which are released as a gas off the skin. The whole collection process will take less than 25 minutes.

Do I have to take part?

No, it is up to you to decide. We will go through the information sheet with you and give you a copy. If you agree to take part, we will ask you to sign a consent form, and keep a copy for yourself, to show you have agreed this. However, you are free to withdraw from the study at any time.

Where will the study be held?

The sample collection will be done in a place which is convenient for you, usually at your local hospital. The samples will then be sent to Professor Barran’s laboratory at the School of Chemistry, University of Manchester. Before being sent to Prof Barran’s laboratory, the samples will be given a study code so there will not be any way we can identify you from your samples. Prof Barran’s laboratory will use mass spectrometry to identify all the chemicals in the sample. We may also give the samples to our expert-smeller to try and identify those which were taken from someone with PD. The samples may also be sent to Medical Detection Dogs for training dogs to diagnose PD.

What will the study involve for me?

If you agree to take part in the study, we will take some brief information about you including your age, your sex, other medical conditions, the medications you are taking, your height and your weight. We will then collect the chemicals from your skin using the sellotape, the gauze swab and the small tube stuck to your skin. The sellotape is a little uncomfortable to remove. Otherwise the procedure is painless. The whole procedure takes less than 25 minutes. We may ask you if you agree to have a second sample taken in a few months time.

What are the possible disadvantages of taking part?

You may experience some mild discomfort when the sellotape is removed. Otherwise the study is painless. Aside for the time involved in taking part, there are no other disadvantages of being involved in the study.

Will I be compensated for my part in the study?

We have a small amount of money available to pay for travel expenses if required. Please discuss this with your researcher.

What are the possible benefits of taking part?

There will be no direct benefit to you from taking part in the study. The study will hopefully enable us to develop a test that can help diagnose Parkinson’s disease at a much earlier stage.

What if there is a problem?

Any complaint about possible harm you have suffered, or the way you have been dealt with during the study, will be addressed. Details of this are given in part two.

Will my taking part in the study be kept confidential?

Yes. We will follow legal and ethical practice and handle all information about you in confidence. The details are given in part two

Who is funding the study?

The study is funded by Parkinson’s UK.

Where will the results of the study be published?

The results of the study will be published in a scientific journal. When results are available, they will be published on the Parkinson’s UK website – www.parkinsons.org.uk. You will not learn the results of your individual sample.

Who will have access to the study data?

Individuals from the University of Manchester, NHS Trust or regulatory authorities may need to look at the study data to make sure that the research is being carried out appropriately. Please be assured that anyone accessing your data will have a duty of confidentiality to you as a research participant. Aside from this, data will only be accessed by the research team. The data collected during this study could be used to support research in the future. We may use the anonymous data in future studies or share it with other researchers working on other studies. All of the data used for future research will be anonymised and so no-one will be able to identify you.

 

PART TWO

 

What if I don’t want to carry on with the study?

If you withdraw from the study, we would normally use any information collected up to this point unless you request us not to. We would not use any identifiable information.

Will my taking part in the study be kept confidential?

Yes. Information about you that is collected as part of the study will be identified by a unique study number in order to maintain confidentiality. This data which cannot be used to identify you will be stored on a University computer. Data which can be used to identify you will not be stored apart from the consent form.

What will happen to the results of the study?

Once the study is finished, we plan to publish the results in a medical journal so that others working in the same field will be aware of our findings.

Who is organising the research study?

The study is organised and sponsored by the University of Manchester.

Who has reviewed the study?

The study has been given a favourable ethical opinion from South West – Exeter Research Ethics Committee.

 

Further information and contact details

Dr Monty Silverdale

Principal Investigator

0161 206 2574

Monty.Silverdale-2@manchester.ac.uk

 

Dr Uma Nath

Principal Investigator

City Hospitals Sunderland

Consultant Neurologist

01915656256

Pathikonda.nath@chsft.nhs.uk

 

Dr Barbara Wilson

Clinical Trials Officer

DeNDRoN Specialty

Clinical Research Network

0191 208 1337

barbara.wilson@ntw.nhs.uk

 

Anita Rutkauskaite

Research Assistant

DeNDRoN Specialty

Clinical Research Network

0191 208 1336

anita.rutkauskaite@ntw.nhs.uk

 

 

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