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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 in 2021.  Please see the sections Use of NHS/cancer registry data to follow-up participants for additional year and What Happens if I change my mind for the most recent updates to the study.

SYMPLIFY

SYMPLIFY recruitment was very successful with over 6000 people referred to a hospital clinic by their GP to check if their symptoms were due to cancer signing up to take part in the study between July and November 2021.

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. 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.  National Institute for Health Research (NIHR) staff helped 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 was not run on your blood sample until you 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.

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. University of Oxford and GRAIL Bio UK Ltd are Joint Data Controllers. This means that we are responsible for looking after your information and using it properly.  The University of Oxford, based in the United Kingdom, processes information for research as a task in the public interest.  GRAIL Bio UK Ltd, also based in the UK, processes information as it is necessary for its legitimate interests, specifically for conducting scientific research in the detection of cancer through the SYMPLIFY Study  .  GRAIL Bio UK Ltd do not receive any of your personal information that may directly identify you (NHS number, date of birth, postcode and sex) but do receive some of your health information, for example, if you were admitted to hospital while participating in the study.

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, which is currently planned to be in January 2025. 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. The Confidential Advisory Group (CAG), an independent body which provides expert advice on the use of confidential patient information has reviewed and given a favourable opinion to our request to collect follow up data for a further year.

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 / cancer registry services (NHS number, , 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.                          

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 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.

 Use of NHS/ cancer registry data to follow up participants for additional year 

NHS England, or Digital Health Care Wales for participants living in Wales, recently (Autumn 2024) sent a letter to inform you that the study team would like to access your centrally held data for an additional year. Depending on the results of this additional year’s data we may wish to access your centrally held data for a third year but we will not access data beyond three years. This will allow us to check if there are any future diagnoses that may help us assess the long term accuracy of the GalleriTM test.  A copy of this letter can be viewed by following this link:  Letter Copy.

To contact you we have had to process your identifiable data without consent.  The processing of identifiable data without consent and outside the direct care team is undertaken with ‘s251’ support from the Health research Authority (HRA) on advice from the Confidentiality Advisory Group (CAG).

You can read more about Section 251 and CAG at https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/confidential-patient-information-and-regulations/ Researchers at University of Oxford do not have direct access to your name and/or address. If you do not wish us to continue to collect your centrally held data for no longer than a further 24 months please see the What Happens if I Change My Mind section below for how to opt out.  If you do not let us know you wish to opt out, the Section 251 support will allow us to access your centrally held NHS record for no longer than a further 2 years.

You can read more about Section 251 support at https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/confidential-patient-information-and-regulations/

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 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 symplify-pc@phc.ox.ac.uk 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 the SYMPLIFY team not to access your centrally held date for a further year please get in touch in the next 4 weeks to let the team know. If you live in England, do not want us to continue to collect your data and have already asked for the national data opt out to be applied to your medical records then the opt out will be applied and you do not have to contact us directly.

You can contact us by emailing the SYMPLIFY data team: symplify-pc@phc.ox.ac.uk or by writing to:

SYMPLIFY

Radcliffe Primary Care Building

Nuffield Department of Primary Care Health Sciences

Radcliffe Observatory Quarter

Woodstock Road

Oxford

OX2 6GG

 

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 centrally held data to be accessed for no longer than 2 more years then you do not need to do anything.

How do I find out about the results of the study? 

The SYMPLIFY main results were published in Lancet Oncology in July 2023 and you can read a summary of results at: https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-new-blood-test-to-help-diagnose-cancer-earlier-symplify

We hope the results of SYMPLIFY will lead to improvements in the way cancer is diagnosed for all patients in the NHS. We are continuing to look at the data and plan to publish further results, including results on the additional follow up. Please bookmark https://www.oncology.ox.ac.uk/clinical-trials/oncology-clinical-trials-office-octo/current-trials/symplify for updates on all future results.

Many thanks again for your invaluable contribution to the success of SYMPLIFY.