Privacy Statement for Research on Melanoma carried out by the Section of Epidemiology and Biostatistics at the University of Leeds

 

Information for patients participating in our research studies

 

The Section of Epidemiology & Biostatistics is a research department within the School of Medicine of the University of Leeds.

 

The Section conducts research projects which explore genetic and environmental factors that may influence the risk of developing disease and the likelihood of surviving it. The diseases we research include malignant melanoma, colorectal cancer and testicular cancer.  In order to conduct our research projects we collect and process data in electronic databases and paper filing systems. This data is considered to be personal data according to the EU Directive 95/46/EC and implementing laws in the UK (2018 Data Protection Act).

 

To learn a little more about some of the melanoma related research that we have undertaken you can visit our website via this address – http://genomel.org

 

What types of personal data do we process?

We process the following types of personal data under articles 6 and 9 of the Data Protection Act 2018 on the legal basis that it is ‘In the Public Good’ as our research is designed to help individuals make choices about how they may reduce their risk of developing certain diseases or improve their likelihood of surviving them:

  • Health related information obtained directly from people participating in our research.
  • Health related information about people participating in our research which is obtained from healthcare providers which, depending upon the research project can include laboratory data, genetic sequencing data.
  • Health related information obtained from government data providers such as NHS Digital and Public Health England and other research organisations.

 

Why do we use personal data?

As a university we use personal data to conduct important research to improve health, care and services. When people agree to take part in our research projects, we use their data in the ways needed to conduct and analyse the research project. Each research project is different and a detailed information sheet is given to people who are considering taking part in our research projects which includes details of the types of data we will collect, how it will be used and who will have access to it.

In general, we process personal data:

  • To help identify and recruit eligible participants into our research studies
  • To correctly track those research participants who have consented to take part
  • To correctly Identify samples and data donated by participants
  • To collect and clean data for use in statistical analyses in the conduct and interpretation of our research projects
  • To satisfy other ethical, legal and regulatory requirements which apply to the conduct of our research projects

 

If you would like to know more about the contribution that people make when participating in our research projects and how personal data is used by universities and the NHS to help improve treatments and healthcare services this video provides more information: https://www.datasaveslives.info/

 

 

How do we protect the personal data that we hold?

As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personal data from people who have agreed to take part in research and that these research projects are approved by a research ethics committee.

We only use the minimum personally-identifiable information possible and ensure that this is held securely with strict arrangements about who can access it.

 

Who has access to the personal data that we hold?

Authorised people within the University of Leeds who are working directly on our research projects will be given access to personal data but it will be limited to what they need to access to undertake their role.

Each research project is different and more detailed information is given to people participating in our research projects when they decide to take part, this will include the types of data we will collect, how it will be used and who will have access to it.

In order to conduct our research properly we are required to report certain information to the following organisations. This information will contain data which has had personal identifiers such as name and date of birth removed:

  • Health Research Authority Ethics Committee
  • National Cancer Research Network
  • We publish the results of our analyses in scientific journals and produce lay summaries of these for our web site, however these do not contain any identifiable information.

 

Do we use personal data for other purposes?

When people agree to take part in a research project, some of the data that we collect may be provided to researchers running other research projects both within the University of Leeds and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. This data is only used to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will be used for the purpose of health and care research and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance. We always specifically ask participants for their permission before we share any of their data with these other agencies.

 

Where can you get further information?

If you have taken part in any of our studies you will have received a detailed participant information sheet. This information sheet describes precisely what personal information we collect from you, how we process that information and how long we keep it for. It also details how you can notify us of your desire to withdraw from the study and how you can request that we destroy any of the information and/or samples you have given us, if that is possible. If you wish to contact us to discuss aspect of the study you have taken part in or you would like a copy of any of our information sheets and consent forms please email c.l.r.walker@leeds.ac.uk. Follow the link below for further information regarding freedom of information requests: http://www.leeds.ac.uk/info/130521/freedom_of_information.

 

How do we deal with complaints?

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our general postal address is University of Leeds, LS2 9JT, UK.

The postal address for data protection issues is University of Leeds, Room 11.72, EC Stoner Building, Leeds, LS2 9JT

Our Data Protection Officer is Adrian Slater and you can contact them at a.slater@adm.leeds.ac.uk

The University of Leeds is a registered Data Controller with the UK Information Commissioner’s Office (registration number Z553814X).

Information of participants in the Leeds University study of melanoma in families

MREC 99/3/45 – Studies of Familial Melanoma

In the years between 1989 and 2018, many individuals who have had melanoma or who have had melanoma in their families, took part in research led by Professor Julia Newton-Bishop. Research nurses Liz Pinney, Linda Whitaker and Susan Haynes worked with Julia for many years to collect information about family histories, to count moles on the skin and to take blood samples.

If you think you or a member of your family took part in this research we have some important information below, which we would like you to consider. But first however, a brief overview of the findings of this study.

In all, 2397 people took part in the study from all over England and Wales. The information provided has led to increased knowledge about many aspects of melanoma occurring in families. We have summarised many of the published academic papers and these lay summaries which can be accessed here.

The research showed:

  • That in many families with melanoma, family members have large numbers of moles (melanocytic naevi), but not all such families.
  • That even within “moley” families, melanoma can occur in family members with normal moles so that having larger numbers of moles than is usual is a poor guide to risk.
  • That the commonest inherited gene which increases melanoma risk is called CDKN2Aand the protein the gene produces is called p16. This gene is damaged (mutated) in the majority of families in England and Wales with 4 or more family members who have been affected with melanoma, but not all.
  • Families with mutations in the CDKN2Agene in the UK seem to be mainly at increased risk of melanoma of the skin. A few may also be at increased risk of pancreatic cancer or other cancers associated with smoking. For families with melanoma it is therefore important never to smoke, and to avoid sunburn as this is known to increase melanoma risk.
  • Rarer mutations in other genes have been found in recent years. These have been harder to find as they occur in only around 1%: 1 in 100 families. They occur in genes called POT1, TERT or BAP1. In these families, there is an increased risk of melanoma of the skin but some additional cancer types which differ according to the gene that is mutated.

Important information about the data we collected as part of this study

In order to carry out this research we collected data from families on family history which we have safe-guarded most carefully but which we now feel that we should make anonymous. We want to continue to work on the information but we feel that we should destroy the link between the information and family members’ details.  We want to do this to ensure that participants’ personal details remain safe in the long term, but it means that we would not be able to help if family members telephone us or e-mail to seek advice specifically about their families.

 

This information is provided here and will be left on the web site for 3 months before we destroy the link. If you have participated in the research and feel that there is a reason NOT to destroy the links for your family then please let us know by either of the e-mail addresses listed below or by these telephone numbers.

 

Date May 18th2018

We will continue to add new information to the web site in the future as new discoveries which may be of interest to families with melanoma.

 

Prof. Julia Newton-Bishop

j.a.newton-bishop@leeds.ac.uk

Professor of Dermatology and lead research investigator.

Tel: +44 (0) 113 2064573

 

Mr Christy Walker

C.L.R.Walker@leeds.ac.uk

Section Research Nurse

Tel: +44 (0) 113 2064575

Risks of cancers related to smoking in families with CDKN2A mutations

 

High risk of tobacco-related cancers in CDKN2A mutation-positive melanoma families.

Two research groups within GenoMEL have looked at the risk of cancers other than melanoma in families with inherited mutations in the p16 or CDKN2A gene: a group in Stockholm Sweden and another in Leiden, the Netherlands.

We have added a summary of the paper published by the Stockholm group in to the Plain Language Summaries section of the web site which is to be found in the Information for Patients. Both the Swedish and Dutch research groups showed that mutation carriers were at very significantly increased risk of smoking related cancers compared with people without the mutation.

Whilst these studies were conducted in two countries only it seems very important to advise families with mutations in this gene, that it is very important that they do not smoke tobacco,

 

 

Predictive Biomarker Research

A predictive biomarker is a test which provides information for medical teams and patients about how likely a particular treatment is to benefit that patient and or the risk of side effects. Using predictive biomarkers is an important part of the aim to deliver “personalised medicine”.  That is, that we need to move away from using the same treatment for everyone, towards choosing treatments more likely to work. There are in fact fewer predictive biomarkers actually being used in practice in 2017, than hoped. It has indeed proved difficult to develop such tests. These are some questions and answers about biomarker research.

Q. Why would treatments for advanced melanoma differ for different patients?

A. Melanoma is a cancer of pigment cells and all melanomas share some characteristics but they also differ: the genetic changes which define cancers occur in the cancer cells at random and cancers are all therefore a little different. Some changes are of no consequence but others mean that a particular drug may or may not to what it is intended to do. Similarly, only a proportion of patients develop most drug side effects and it may be that lifestyles, inherited difference between patients or other health issues play a role.  Personalised medicine aims to be able to predict side effects and whether or not a drug will work so that patients and their medical teams can choose the best option.

 

Q. Why has it been so difficult to find good predictive biomarkers?

A. There are many reasons. First it requires very large studies of many patients willing to give samples of their blood or their tumours: maybe thousands of patients being treated in many different clinics. Second, the patients need to be followed up for some time, and information about their response to the treatment carefully collected at each visit. Third, the tests performed must be chosen correctly based upon science, the samples must be collected and processed in exactly the same way in all the clinics, the chosen tests must perform very well in the laboratory and the analysis performed correctly. In fact the way to do the analyses optimally is still being developed using computer tests which are both statistical or a specialist statistical approach called “machine learning”. Finally, the scientific approaches to the analysis of samples is changing all the time: that is that options are increasing all the time and the treatment options are changing all the time so large scale studies set up to recruit sufficient patients and test them in a particular way must be “future proofed” so that the results stand the test of time.

Q. What will improve the identification of good biomarkers?

A. We think that the best way is to work together across the UK and internationally to perform large studies, using the best tests and getting the best analysis teams together. Indeed this is the view of the UK Medical Research Council which funds MRC Stratified Medicine Consortia. Some of the GenoMEL/MELGEN research groups have submitted an application in June 2017 to the MRC for a Melanoma Stratified Medicine consortium. It is very important to involve patients in discussions about research such as this and Professor Newton-Bishop presented the issues to the UK Melanoma Patient Conference in June 2017. We hope that some of the attendees at this meeting might advise the consortium if funded about how the research should be performed and how to develop a biomarker of meaningful value to patients. A link to this talk is provided here.

 

 

The second UK Melanoma Patient Conference

A summary by Professor Julia Newton-Bishop

The second Melanoma Patient Conference took place in Birmingham this year on June 16th and 17th. It was expertly organised (as was the first ever conference) by Imogen Cheese. It was very well attended by people who have experienced melanoma themselves or in their families, and representatives of the charities created to support melanoma patients. The speakers included medical staff treating melanoma patients, patients themselves and researchers. I think that this is a wonderful, and much needed event and I sincerely hope that it will continue and grow, supporting patients and enabling empowerment.

Filmed presentations are available on YouTube if you search for MPCUK2017. These include “Patient Voices” which, from the number of views recorded already, are very valuable.

 

The next UK Melanoma Patient Conference will take place on Friday and Saturday June 22nd and 23rd 2018. Registration will open in January 2018 and e-mail enquiries via enquiries@melanomapatientsconference.co.uk