UK EDI Patient information Sheet

UK-EDI: United Kingdom Early Detection Initiative for Pancreatic Cancer

You have been invited to take part in a research study. Before you decide, it is important that you understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish.

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

The clinical team in charge of your care will go through the details with you, but please ask us if there is anything that is not clear, or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.


Part One

What is the purpose of the study?

The UK-EDI study is a project, with the overall aim of improving detection of pancreatic cancer in high-risk groups, using a variety of different methods.

Most cases of new-onset diabetes mellitus are due to lifestyle or genetic factors, but in a small subset of individuals diagnosed with new onset diabetes mellitus (approximately 1 in 100 people (1%)), the diagnosis of diabetes is believed to be an early sign associated with the development of pancreatic cancer (which should actually be categorised as type 3c diabetes).

Type 3c diabetes is caused by damage to the pancreas by conditions such as pancreatitis, pancreatic cancer and cystic fibrosis. It is important to distinguish individuals with type 3c diabetes, which includes those with pancreatic cancer-associated diabetes mellitus, from other types of new-onset diabetes mellitus. Currently it is not possible to accurately do this. We would like to be able to find ways to distinguish between the forms of diabetes so effective screening programs may be developed to detect pancreatic cancer much earlier and hopefully provide better treatment options for these patients.

The UK-EDI study will collect clinical data, quality of life data and biological samples from a large cohort of individuals with new-onset diabetes to help us try to distinguish between type 2 and type 3c diabetes, identify early signs of pancreatic cancer and determine how cost-effective screening would be if it were possible.

Why have I been chosen?

You are being asked to take part in this study because you are 50 years of age or older and you have been diagnosed with diabetes in the last 6 months.

A member of the clinical team will check you are eligible to take part before enrolling you into the study.

We will be asking 2500 participants to take part in this study across the UK.

Do I have to take part?

No. It is up to you to decide whether or not to take part. If you do, you will be asked to sign a consent form, but you are free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.

What will happen to me if I take part?

If you decide to take part in this study, an appointment will be made for you at your local participating clinic to discuss the study in more detail. Before deciding whether to take part in the study, you will have the opportunity to discuss the study with your family and friends, as well as the medical team looking after you. If you choose to take part in the study, you will be asked to sign a consent form.

As part of the study, you will be asked to attend an initial research appointment and four further follow up research appointments over a period of 2 years at your local participating clinic.

A schedule of what will happen at each research visit is below:

  Initial Appt Mth 6 Appt Mth 12 Appt Mth 18 Appt Mth 24 Appt
Completion of Consent Form x        
Collection of demographic information x x x x x
Blood Sample for Research x x x x x
HbA1c Level x x x x x
Completion of Questionnaires x x x x x
Medical and surgical history x x x x x

Initial Research Appointment

At your initial research appointment, a member of your clinical team will collect information on your age, medical and surgical history to check you are eligible to take part in the study. This may involve a review of your medical notes, as well as direct questions. If you are eligible to take part, you will be asked to complete a consent form.

At this visit, we will take up to 50 mL (just over 3 tablespoons) of blood. Some of this blood will be used to check your HbA1c level, which is a measure of the sugar levels in your blood. The rest of the blood will be collected as part of this research project.

You will also be asked to complete two questionnaires; one in relation to the management of your diabetes and one related to your quality of life.

Your initial research appointment will take up to 1 hour.

Follow-Up Research Appointments

At each of your follow up research appointments, the research team will review your medical and surgical history.

At each visit as at the initial visit, up to 50 mL of your blood will be taken to check your HbA1c level and for this research.

You will be asked to complete the two questionnaires completed in your initial visit. The follow-up visits will take approximately 30 minutes each.

After 36 months of you being on the study a search of your health records will be made by a member of the research team to check on your health status. You will not need to attend an appointment for this.

What do I have to do?

If you agree to take part in this study, you will be expected to attend the research appointments at the times agreed with the research team. It is important that you must tell the research team about any changes to your health since your last visit.

You can speak with the research team about any concerns you have by using the contact numbers in this information sheet.

What are the possible disadvantages and risks of taking part?

There may be some minor but short-lasting discomfort when providing a blood sample; you may experience a scratching sensation as the needle goes in. You may also experience some bruising.

What are the possible benefits of taking part?

This is an observational scientific research study. It is unlikely that the study will be of direct benefit to you. However it is hoped that this research will eventually lead to improvements in screening for, and diagnosis of, pancreatic cancer.

What happens when the research study stops?

The visits you have as part of this study will be extra to the medical appointments you attend for review of your diabetes. After the research study stops, you will continue being followed up for your diabetes as you have during the study with your own clinicians. If you have any ongoing concerns following the completion of this research study please discuss these with your doctor.

What if there is a problem?

Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information is given in Part 2 of this information sheet.

Will my taking part in this study be kept confidential?

Yes. All the confidential information about your participation in this study will be kept confidential. In this research study we will use information from you and your medical records. We will only use information that we need for the research study. We will let very few people know your personal information, and only if they really need it for this study.

Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.

At the end of the study we will save some of the data in case we need to check it and for future research. We will make sure no-one can work out who you are from the reports we write.

The detailed information on this is given in Part 2.

Contact for Further Information

Should you have any further queries regarding this study or about any of the treatments described above,

Please contact:

  • Dr J Wimborne - GP
  • Paula Melrose & Joanna Beldon – Research Nurses

Contact Us

This completes Part One of the Information Sheet.

If the information in Part One has interested you and you are considering participation, please continue to read the additional information in Part Two before making any decision.


Part Two

What if new information becomes available?

Sometimes during a research project, new information becomes available about the condition being studied. If this happens, a member of the research team will tell you about it and discuss with you whether you want to or should continue in the study.

If the study is stopped for any other reason, you will be told why.

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

If you no longer want to carry on with the study, please inform the research team immediately. This will not affect the standard of care you receive. If you withdraw from the study, you will no longer attend study-related follow up visits.

You will be asked if you will be specifically withdrawing from the following:

  • All further participation in the study including any further follow up.
  • Withdrawal of consent for the use of samples obtained in the study.

Where possible we will destroy the samples you have provided.

In some cases, the samples you have provided may have been processed into the form of DNA or protein and may have been combined with samples from other patients. In this case, your samples will be coded but we will not be able to withdraw or destroy the samples.

In the unlikely event that you lose capacity whilst on the study to consent to remain in the study you will be withdrawn. Data and samples you have provided prior to that point would be retained and used confidentially for the purposes for which consent had been originally provided.

What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak with the research team who will do their best to answer your questions. If you remain unhappy and wish to complain formally, you can do this through the normal NHS Complaints Procedure, via the Patients Advice and Liaison Service (PALS). PALS can provide confidential, impartial advice regarding concerns and complaints. PALS helps to improve the NHS by listening to your concerns and suggestions

The contact details for the PALS Office are as follows: Patient Advice and Liaison Service for Morecambe Bay CCG - 01539 795497.

If you are harmed by taking part in this research project and this is due to someone’s negligence, then you may have grounds for legal action for compensation against the NHS Trust where you are being treated, but you may have to pay for your legal costs. The normal National Health Service complaints mechanisms should be available to you (if appropriate). If you experience non-negligent harm arising from the management or design of the research then the University of Liverpool clinical trials insurance may apply as the sponsor of this investigator-initiated study.

Will my taking part in this study be kept confidential?

The University of Liverpool is the sponsor for this study based in the United Kingdom (UK). We (The University of Liverpool) will be using information from you and/or your medical records to undertake this study. Analysis of data will be conducted by research teams in the University of Liverpool and the University of Strathclyde, both will therefore act as joint data controllers for this study. This means that they are responsible for looking after your information and using it properly. The University of Liverpool will keep identifiable information about you for 25 years after the study has finished. The University of Strathclyde will not retain data once the results of this study are published. We will keep all information about you safe and secure.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information

Bay Medical Group will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the Liverpool Clinical Trials Centre, University of Liverpool and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Bay Medical Group will pass these details to the Liverpool Clinical Trials Centre along with information collected from you and your medical records.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. The only people in the Liverpool Clinical Trials Centre who will have access to information that identifies you will be the people who need to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.

Bay Medical Group will keep identifiable information from this study for 25 years after the study has finished.

If you join the study, some parts of your medical records and the data collected for the study will be looked at by authorised persons from the study team or their collaborators who are also involved in organising this research project. Coded confidential data may be used in a number of research projects and/or for research related to the development of pharmaceutical products, diagnostics or medical aids by other scientists and research organisations within and outside the United Kingdom, in universities, the NHS or commercial companies involved in medical research worldwide, which may also involve discussions with regulatory authorities. Data may also be looked at by representatives of regulatory authorities and by authorised people from the NHS Trust or other NHS bodies to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a research participant.

With your permission, a copy of your completed consent form will be sent to the Liverpool Clinical Trials Centre to allow them to check you have agreed to take part in the study. This will be kept in a secure location away from all the study data.

With your permission, details of your initials, date of birth and NHS number will be held by the Liverpool Clinical Trials Centre for the purposes of being able to check your long-term health status. This information will be held securely and will not be shared with any other organisation.

Data collected during the study may be transferred for the purpose of analysis/registration within or outside the United Kingdom. Some countries outside the UK may not have laws, which protect privacy to the same extent as the Data Protection Act in the UK. We will take all reasonable steps required to protect your privacy, and any confidential information (such as your name, NHS number and date of birth) will be removed before being shared.

Involvement of the General Practitioner/Family Doctor (GP)

With your consent, your GP will be informed of your involvement in the study. Any other medical practitioners who treat you, e.g. should you be admitted to hospital for any reason, will also be notified. Should any unexpected medical findings be identified as a result of taking part in this study these will be shared with yourself and your GP.

What will happen to any samples I give?

Some of your samples will be analysed at your hospital for the measurement of your blood sugar levels.

With your permission, we would also like to transfer blood samples to the University of Liverpool for storage and analysis as part of this research project.

The researchers at the University of Liverpool work closely with other scientists in the UK and around Europe and the United States, with your permission, your samples may be transferred

to these research collaborators for analysis or for use in future scientific studies. These samples will be used only for investigating diabetes/pancreatic diseases and cancers. The use of your samples in future research is optional.

The samples will be kept in a secure place until we need them; nobody outside of the study will have access to any confidential information that you give to us. Confidential details (such as your name, address and GP details) will be kept locally and not made available to collaborators.

Your sample will be coded and the researchers carrying out tests on the samples will not be given information they do not need to carry out the tests and analyse the results. Coded is not the same as anonymous. It will be possible to use the codes to identify that a result is from your sample. However, we do not plan to do this unless there is a good reason to do so. We will maintain this information so that we can properly manage the samples donated. For instance, sometimes we may need to update our record of your clinical details to help us interpret the results of tests.

Commercial organisations (e.g. diagnostics companies) may in the future wish to approach the University of Liverpool to collaborate or use some of the samples collected as part of this study to check or confirm scientific work they have done or for scientific discovery. Access to these samples will be strictly regulated by an access committee. No personally identifiable information will be released to organisations requesting the samples. The use of your samples in this way is optional.

If you give your consent, any unused samples at the end of this study will be donated to the Liverpool Clinical Trials Centre Post-Trial Tissue Bank for use in future research projects. This tissue bank makes samples available for researchers. Access to samples is strictly regulated by an access committee and samples will only be released for high quality research projects with ethical approval. No personally identifiable information will be released to researchers requesting the samples.

Will any genetic tests be done?

Some of the tests performed on samples you have provided may involve the isolation of genetic material (DNA, RNA). This could lead to earlier detection of disease and hopefully provide better treatment options for patients. It is important to study the samples this way to find the answers for this research project.

Genetic science is changing rapidly and we would like permission to use new improved tests which may appear in the future.

As stated earlier, your samples will be coded. Coded is not the same as anonymous. It would theoretically be possible to use the codes in your DNA to identify that a result is from your sample. We do not plan to do this but you should be aware that this linkage is a possibility.

We would expect that the samples will be tested once you have completed your study visits and so do not expect that they will provide results of any individual clinical significance. We do not therefore expect to contact you unless there is a good reason to do so.

What will happen to the results of the research study?

It is intended that once the study is complete a report will be written and the results will be published to make them available to the public. You will not be named or identified in any publication.

What rights do I have to the results of the research?

Any information derived directly or indirectly from this research, as well as any patents, diagnostic tests, drugs, or biological products developed directly or indirectly as a result of this research may be used for commercial purposes. You have no right to this property or to any share of the profits that may be earned directly or indirectly as a result of this research. However, in signing this form and donating blood samples for this research, you do not give up any rights that you would otherwise have as a participant in research.

Who is organising and funding the research?

This study and associated research is sponsored by the University of Liverpool and co- ordinated by the Liverpool Clinical Trials Centre. Funding for this study is provided by Cancer Research UK.

Will I receive any payment or reimbursement of expenses?

Reimbursement for reasonable claims for travel expenses will be available when you have attended for the sole purpose of a research visit. A maximum of £15 will be available per visit. No reimbursement will be made for routine clinical appointments.

Your doctor will not receive any payment for including you in this study.

Who has reviewed the study?

The study has been reviewed for scientific content by Cancer Research UK and the London – West London & GTAC Research Ethics Committee has reviewed the study for ethical considerations.

Thank you for taking the time to read and consider this information sheet. Should you decide to take part in the study, you will be given a copy of the information sheet and a signed consent form to keep.