Information for participants who joined the SYMPLIFY study.
This information is for participants who joined the SYMPLIFY study.
The University of Oxford, Sponsor of the SYMPLIFY trial, would firstly like to say thank you for taking part in the study.
We would also like to update you on the progress that has been made since you signed up to take part last year.
The study is designed to help develop a new blood test for early identification of different types of cancer. Cancer is easier to treat if it is diagnosed early. In SYMPLIFY we are checking the performance of a new test, known as GalleriTM which detects DNA from cancers in the blood.
SYMPLIFY recruitment was very successful with over 6000 people referred by their GP to check if their symptoms were due to cancer signing up between July and November 2021.
The SYMPLIFY team are comparing the results of the GalleriTM test with the diagnosis made in the NHS to see how well the test performs. To do this we will follow-up what happens to your health by accessing your data held centrally by the NHS.
Who is organising and funding this study?
The Chief Investigator responsible for leading this study is Professor Mark Middleton, at the University of Oxford. The University of Oxford also acts as the research sponsor. This means they are legally responsible for the study organisation and for overseeing the work of the researchers.
The study is funded by an unrestricted educational grant from GRAIL LLC. who are also responsible for processing the blood samples obtained from participants, and undertaking and reporting the test. In kind support is provided by NHS England and NHS Wales to provide data from central datasets and to assist with project management. The National Institute for Health Research (NIHR) is making staff available to help with patient recruitment and to collect data. The Oxford NIHR Biomedical Research Centre provides core resource to the Oncology Clinical Trials Office and funds the Chief Investigator.
What has happened to my blood sample?
The blood sample you donated was sent to a laboratory in the UK and prepared for analysis using the GalleriTM test. This analysis has been done in the United States.
If any of your sample remained after it had been used in this study, it will have been provided to GRAIL for other research to improve the GalleriTM test, and to develop new products for early cancer detection and to see how well they work. Your sample will not be used for any other purpose and will not be shared with any other organisation. You will not receive any updates about your sample.
Will I get the blood test results?
No, the GalleriTM test will not be run on your blood sample until you have completed all the usual tests at the hospital. Your doctors won’t get the results either, because at the moment we are still checking how well the GalleriTM test works. It does not currently have a CE (or UKCA) mark.
How will my data be used during the study?
The SYMPLIFY team at the University of Oxford will be using information collected from you and from your medical records to undertake this study. Your data will be kept secure and confidential. We will follow ethical and legal practice and all information about you will be handled in confidence. This means we will only tell those who have a right or need to know. Your data and samples will have your unique study number instead of your name or other information that identifies you directly.
UK Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest.’ The University of Oxford, based in the United Kingdom is the Data Controller for this study. This means that we are responsible for looking after your information and using it properly.
Further information about your rights with respect to your personal data is available at https://compliance.web.ox.ac.uk/individual-rights
We will keep identifiable information about you for up to 3 months after the study has finished. This excludes any research documents with personal information, such as consent forms, which will be stored in secure electronic files at the University of Oxford for three years after the end of the study.
For more information see https://compliance.admin.ox.ac.uk/research-data
Who has reviewed this study to make sure it is being conducted safely and appropriately?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been reviewed and given favourable opinion by the London - Central Research Ethics Committee.
The study has also been approved by NHS England and NHS Improvement, as part of their work to improve cancer screening for the people of England. Health & Care Research Wales/NHS Wales are also supporting this work to improve cancer screening for the people of Wales
Who will be able to view my data?
Only members of the study team who need to see your personal information will have access to it for the purposes of the trial.
The hospital where you joined the study will keep your name and contact details confidential and will only pass such information to the University of Oxford as is needed to use NHS Digital/ cancer registry services (NHS number, GP practice details, date of birth, postcode and sex). Responsible members of the University of Oxford, the hospital and regulatory organisations may be given access to your medical records for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations.
If required, the hospital may write to your GP practice to request access to their records if the data cannot be retrieved from NHS Digital /cancer registry services. If so, the GP will retain a copy of your consent form as per their policy for retaining medical records.
The hospital will keep identifiable information about you from this study for a number of years after it finishes, as per local NHS policies for retaining medical records.
Use of NHS digital/ cancer registry data to follow-up participants
In order to compare the results of the GalleriTM test with diagnoses made in hospital, we will use the NHS database ‘NHS Digital’ and/or national cancer registries to receive some information about you e.g. to confirm your current medical status. If you gave written consent, your hospital will pass your NHS number, date of birth, postcode and sex at birth details to the University of Oxford, who will use these details to access these services. Your identifiable information will be kept in a separate, secure database away from other data about you in the main study database.
The SYMPLIFY team at the University of Oxford will follow-up what happens to your health by accessing your data held centrally by the NHS. Data collected from centrally held records will also include details of participants’ care from before the date they agreed to enter the study. This is to understand the route by which participants came to be referred for tests to see if their symptoms might be due to cancer and to see if the multi-cancer early detection test performs differently in different circumstances. NHS Digital has recently sent a letter to remind you of your rights and where you can find more information about these. A copy of this letter can be viewed by following this link: Letter Copy
What Information will be sent to GRAIL, LLC. in the United States?
Some of your information will be sent to GRAIL, LLC in the United States. This information will not be identifiable but will be personal and will include information with regards to biological sex at birth, age, ethnicity, health status and any diagnosis relevant to the original GP referral for which you were invited to join the study.
The information and blood samples that GRAIL LLC. in the United States receives will not contain your name, date of birth or other information from which you can readily be identified. Only pseudonymised data - data that is linked to a code number instead of your name or other identifiable details - will be sent to GRAIL, LLC in the United States. GRAIL will not have access to the link between the code and your name as this information is held only by the University of Oxford.
The people in the US who process or store your information must follow the relevant Data Protection requirements set by the Data Controller (University of Oxford) about keeping your information safe. They will use this information for their part in the study and, like the samples, retain it at the end of the study. They will not at any point have information that identifies you.
Some countries, including the United States, have been found by the European Commission not to offer the same level of data protection as that found in the European Economic Area. Therefore, GRAIL, the NHS, and the University of Oxford have entered into a data transfer agreement in a form approved by the European Commission to make sure that your information remains protected after it is sent to GRAIL.
Please contact the SYMPLIFY team by emailing email@example.com if you wish to obtain a copy of the standard data transfer/sharing agreement.
What happens if I change my mind?
If you would prefer for your pseudonymised data not to be sent to GRAIL LLC. in the United States, please get in touch in the next 4 weeks to let the SYMPLIFY team know.
You can do this by emailing the SYMPLIFY data team: firstname.lastname@example.org or by writing to:
Radcliffe Primary Care Building
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
In your correspondence, please include details of your date of birth, NHS number and the name of the hospital at which you joined the SYMPLIFY study (if known).
If you are happy for your pseudonymised data to be sent to GRAIL LLC. in the United States, then you do not need to do anything.
How do I find out about the results of the study?
We won’t be able to share the results of the study until after it is finished. The study will run for about 3 years in total with a planned end date of 30th June 2023.
We have now recruited all the 6,000 participants required for the study and are still collecting the information about them, we then need to analyse all that information.
Once the information is analysed, we can share the results of the study publicly. Often this is in academic journals, and sometimes a press release. It will not be possible to identify you in any results that are published.
We hope the results of SYMPLIFY will lead to improvements in the way cancer is diagnosed for all patients in the NHS.
Many thanks again for your invaluable contribution to the success of SYMPLIFY.