About the ACED Cohort and FAQ

What is the purpose of this project?

This project will provide a resource of biological samples and data to ACED researchers to study the early detection of cancer. We aim to bring together a group of thousands of adults eager to participate in future research projects related to the early detection of cancer. We will invite research participants to enrol in future studies based on their risk factors, family history, and lifestyle.

We would like to understand the leading causes of cancer, why individuals develop certain cancers, and why it is aggressive in some cases and not others. One of the key aspects would be finding out when should we start testing individuals. We would also like to understand what early microscopic changes mean and how best to intercept those changes before they progress into cancer. Cancer is the second leading cause of death worldwide, and the incidence is increasing. This trend might be due to an ageing population, but it could be due to other factors. We want to understand which ones we should focus on and intervene.

This project will invite cancer-free individuals to give information about their medical and family history, lifestyle, and wellbeing; and provide samples of blood/saliva and urine. We will ask research participants to come to the research clinic every year to donate samples and answer the questionnaires to track any changes over time. We want to count on the participation of research volunteers for ten years, but they can withdraw at any time without giving a reason.

We will code participants' samples and answers with a unique code or identifier. This is called pseudonymisation. ACED researchers interested in this resource will then apply to access pseudonymised samples to investigate the role of different lifestyle factors and genetics changes in cancer development. This information may lead to new tests and treatments for various cancers to detect them earlier and successfully treat them.

What do I need to do if I join the ACED Cohort?

If you agree to participate, we will go through the project requirements and answer any questions you may have. If you are happy with the information provided, we will ask you to sign a consent form. We will then ask you to complete a health and lifestyle questionnaire and do a short but easy online cognitive test. This information will be used to calculate a risk score. Such a score shows the chances that people like you have of developing certain cancers in the future. We will share that score with you and provide health and lifestyle advice if necessary.

We will then ask you to donate around 50 ml of blood (about ten teaspoons) and a fresh urine sample. Where a blood sample is not possible, we may ask you to give us a saliva sample instead.

We may also invite you to participate in other relevant clinical studies depending on the information you provide. Your participation is voluntary, and you can decline if you don’t want to participate in further studies.

We are also interested in understanding why some cancer types that run within families. Suppose you have a family history of cancer and know your relatives might be interested in this study. In that case, we will ask your permission to send them an invitation letter to join this study if they wish. They, of course, could say no.

This project aims to assemble a group of participants who we follow up over a prolonged period of ten years or more, depending on research funding.

Will I know the results of any blood tests?

Most of the blood taken will be for research carried out by other scientists and stored for future use. Since we are not the ones doing the analysis, we cannot provide any results.

However, we will measure your blood for anaemia (decrease in the total amount of red blood cells) and any abnormal function of your liver or kidneys. We will send any abnormal results to your GP, who will arrange for you to have further blood tests to analyse them in a hospital laboratory. Only hospital tests will be able to confirm your blood results or any diagnosis.

Will you be able to let me know the results of any genetic testing?

We do not expect to carry out any genetic testing as part of this project. However, suppose you participate in one of the other studies in which scientists are doing genetic analysis to determine cancer risk, such as whole genome sequencing. In that case, they might be able to provide you with some information if the technique they use is clinically accredited and you wish to be informed. Any genetic results would only be given to you as set out by that particular study with appropriate genetic counselling in place. We would only inform you about any meaningful and actionable genetic results with your consent.

Is there any disadvantage to participating in this project?

We ask for your commitment to being available for annual research clinic appointments, about one hour each, over several years (possibly ten years, depending on research funding). Moreover, it might be a little uncomfortable having your blood sample taken, but this will only last one minute or two.

Some of the other studies, should you agree to take part, may involve looking at DNA changes and the risks of developing cancer. If results from those studies suggest that there is a significant risk for you or your family members, we will discuss this with you (with your permission). This information might cause you anxiety which you had not anticipated. You will of course be offered the appropriate genetic counselling in the rare event that this happens.

Will I benefit from taking part in this project?

You will not directly benefit, neither clinically or financially, from taking part. However, you may feel positive about contributing to this research, enabling us to progress in the early detection of cancer.

You may also be interested in knowing your probability or risk for particular cancers, which can be calculated using the information you provide in the questionnaires. We will be able to provide this risk score with some reassurance, guiding you through what it means and how you could minimise it. This will be communicated in a letter and you will have the possibility to reach us out if you would like to discuss things further.

Some of your blood will be analysed, and if the result shows any abnormality, we will let you and your GP know.

We hope the information we get from the research will allow us to offer everyone a more accurate and earlier cancer diagnosis in the future.

Can I stop participating in the project at any time?

Yes, you are free to leave the project at any time. If you would like to leave the project you can do so by contacting the ACED Clinic Team by email, letter, phone call or face to face. The ACED Clinic team may ask you why you wish to withdraw, but you do not need to give a reason. Deciding to withdraw from the study has no impact on your future care in any way.

Where will my samples be used and by whom?

Your samples will be processed and stored at the Cambridge Biomedical Campus under the Human Tissue Act 2004 guidance. The samples will be stored using a unique code identifier. Researchers interested in using these samples will need to complete an application form. Their study will need to be ethically approved by the respective regulatory body before the samples are released. This may mean that we may share the data with other scientific research organisations, both in this country and abroad, providing that all the relevant legal agreements are in place.

Can I withdraw my samples?

If you withdraw from the project, we will retain any samples, data and results that we have obtained up until the time of your withdrawal. Any information already provided or results from tests already performed on you or your samples will continue to be used for studies. However, we will not collect any further information about you from the moment you stop participating in the study.

Would my personal data be publicly available?

Absolutely not. The Data Protection Act 2018 and associated laws around clinical studies mean that we, the research team, have to keep a record of your consent and who you are. This information stays in a very secure environment and a few named members of the research team can see it. When you give your consent to participate in the study, we give you a study number, which remains the unique code for your samples and any other study-related information you provide to us.

The study team may use your NHS number and date of birth to check with central NHS registers that the information we have about you remains accurate. Regulatory agencies may also require access to your medical records to ensure that the project abides by UK laws. No external organisation can approach us for any personal identifiable information about you.

Your personal data such as your name, date of birth, NHS number and postcode may be sent to the Office of National Statistics and NHS Digital, Health and Social Care Information Centre to receive future information about your health status. We will do this up to ten years after the last time you give us any sample. We will send this information in a secure format to them. The data we obtain is coded and password protected, so it is very difficult for someone outside the organisation to identify you.

Any publications or associated documents will only include anonymous information. Your anonymised information, including relevant medical and genetic data, may be held indefinitely on international databases accessible to researchers worldwide. Data will include information about your genotype, age-range, and gender. Nobody will be able to identify you by the information contained in these databases. Moreover, your data will not be used to make decisions about future services available to you, such as insurance. Anonymised data will only be available to researchers who have received ethical approval and signed appropriate legal agreements.

This page is subject to change as the project progresses, to include additional questions and related information.