GEM Study

The Gastric Hormone Biomarkers of Preneoplastic Lesions (GEM) Study

The GEM study is funded by Cancer Research UK and is supported by the NIHR Clinical Research Network. It has recently opened to recruitment. It will involve patients from several UK hospitals and will investigate a potential new set of biomarkers for the early detection of stomach cancer.

ClinicalTrials.gov: NCT06085677

Our Data Protection and Privacy Notice

Privacy Notice

This privacy notice explains your rights to your personal information, what you can expect us (the Cancer Screening and Prevention Research Group) to do with your personal data and our lawful basis for doing so. This notice also explains who you should contact if you have any queries or complaints about how we are processing your personal data.

Under the 2018 UK General Data Protection Regulation (GDPR) and accompanying Data Protection Act (2018) ‘personal data’ is any data that can be linked to an identifiable individual (for a full definition see: Information Commissioner’s Office [ICO] website: What is Personal Data?). Some types of personal data, such as health data, are additionally classified as ‘special category personal data’. The law considers special category personal data to be more sensitive and gives it more legal protection (for more information see: ICO website: Special Category Data). As the Cancer Screening and Prevention Research Group processes (processing is the term used to refer to collecting, analysing and storing data) health data, much of the personal data we hold is considered to be special category personal data.

Who is responsible for the lawful processing of your personal data?

The GDPR and Data Protection Act define roles and responsibilities for those involved in processing personal data.

The Cancer Screening and Prevention Research Group (hereafter; CSPRG) are a research group at Imperial College London. The CSPRG can be contacted via the ‘Contact Us’ page on this website. The data controller determines the purpose for which and the manner in which personal data is to be processed (see ICO website: Controllers and Processors). For the personal data held by the CSPRG, the data controller is Imperial College London. The data controller’s representative for our data is the Director of Information Governance for Academic Health Sciences. All queries relating to the handling of personal data should be directed to the Imperial College London Data Protection Officer via email at dpo@imperial.ac.uk. Contact details can also be found at the end of this privacy notice.

Why are we processing personal data?

The research focus of the CSPRG is gastrointestinal cancers which includes bowel cancer, also known as colorectal cancer. In the UK, every year around 42,900 people are diagnosed with bowel cancer alone and over 16,000 people die from this disease. Through our research we hope to reduce the number of people being diagnosed with gastrointestinal cancer and dying from this disease. Much of our work focuses on how to help make bowel cancer screening and surveillance programmes more effective and acceptable for patients, and more efficient for the NHS, and other health services internationally. To understand the effectiveness of bowel cancer screening and surveillance programmes, we conduct large scale studies on procedures conducted and the benefits to patients. Identifiable patient data are usually necessary to track long-term health outcomes from participants enrolled in our studies. The CSPRG therefore needs to collect and hold personal data – often special category personal data. Our more specific purposes for processing data for each of our studies are detailed on the ‘Studies’ pages of our website.

What personal data do we have?

The personal data we hold is special category personal data relating to individual health. For example, for several of our studies we analyse procedure and treatment information, information about cancers occurring, whether they progress and the patients’ long-term health outcomes. In addition, we also often require some basic information about patients such as age and gender to inform our analysis. The full details of the personal data processed for each of our studies can be found on the ‘Studies’ pages of our website.

To fulfil our research aims, we obtain personal data from a variety of sources. Much of our data is either obtained directly from NHS Trusts, or via national health data providers such as NHS England, the Office for National Statistics, the Bowel Cancer Screening Programme, national cancer registries such as Welsh Cancer Intelligence and Surveillance Unit, Public Health Scotland and NHS National Services Scotland. More detailed explanations of our sources of data can be found on the ‘Patient Data’ page and ‘Studies’ pages of our website.

Where data has been obtained from third-party data providers under section 251 of the National Health act 2006 approval, national data opt-outs have been applied by the provider since 2016.

How do we process personal data?

All personal data we hold are processed in secure systems. For each active study we have completed a Data Protection Impact Assessment that has been approved by the Head of the CSPRG (as the Information Asset Owner) and the Imperial College London Data Protection Officer. No processing performed by the CSPRG involves automated decision-making or profiling. Unless stated otherwise on the ‘Studies’ pages of our website, all personal data are processed by the CSPRG and certain third parties (see ‘Third-party processing’ below).

The Imperial College Data retention schedule mandates that data is retained for ten years after the end of a study (see Imperial’s Retention Schedule here). The expected end of these ten-year retention periods for each of our studies are listed under the ‘Studies’ pages of our website under the ‘How long will we retain the data?’ sections.

Third-party processing

For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we will share your personal data with certain third parties:

  • Other Imperial College London employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third-party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.

What is our lawful basis for processing personal data?

Processing personal data requires justification under two legal frameworks: the UK GDPR/Data Protection Act 2018 and under the common law duty of confidentiality.

Article 6 of the UK GDPR lays out six valid bases under which personal data can be processed lawfully. We process personal data under lawful basis 6(1)(e) ‘Public task’ as: processing is necessary for the performance of a task carried out in the public interest. We are also required to have a separate lawful basis for processing the more sensitive special category personal data. Our legal basis for processing special category personal data is Article 9(2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes […]’

In addition, health data (such as that the CSPRG hold) require a separate lawful basis under the common law duty of confidentiality. In some of our studies, patients consented to be part of the study and for the CSPRG to process their data. In other studies, consent could not be sought due to practical considerations or the nature of the study. In these studies, we have obtained lawful permission to obtain and process personal data under section 251 of the National Health Act 2006. The common law legal bases for data processing in each study are explained in the ‘Studies’ pages of our website under the ‘What approvals has the study received?’ sections.

What are your rights concerning your personal data?

The GDPR grants individuals several rights concerning their personal data:

  • The right to object (to processing of the data)
  • The right to correct (inaccurate or incomplete data)
  • The right to erasure (also known as “the right to be forgotten”)
  • The right to restrict processing (e.g. while the accuracy of the data is contested)
  • The right to portability (to have a copy of any data you have provided to us)
  • The right to access (to have a copy of data we hold about you)
  • The right to withdraw consent (if you have previously consented to take part)

If you think that we might be processing your data and you wish to exercise any of the rights listed above, please get in touch using the details on the Contact Us page or by contacting the Imperial College London Data Protection Officer via email at dpo@imperial.ac.uk. Though it may not always be possible for us to fulfil your request, we will respond to your query within one month. For more information on your GDPR rights, please see guidance provided by the Information Commissioner’s Office.

Where can you direct queries or complaints?

Please be aware that individuals also have a right to complain to a supervisory authority – in this case the Information Commissioner’s Office (ICO) – if they feel their data is being used unlawfully. The ICO does recommend that you seek to resolve matters with the data controller – for our data that is Imperial College London – before contacting the Commissioner’s Office. If you wish to raise a complaint on how we have handled your personal data or if you want to find out more about how we use your data, please contact Imperial College London’s Data Protection Officer via email at dpo@imperial.ac.uk, via telephone on 020 7594 3502 or via post at Data Protection Officer, Faculty Building Level 4, Imperial College London, London SW7 2AZ.

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 raise your complaint with the Information Commissioner’s Office. The ICO’s postal address is: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF; Helpline number: 0303 123 1113. Other ways for members of the public to seek ICO advice can be found at https://ico.org.uk/global/contact-us/contact-us-public/public-advice/.

What are the aims of the GEM study?

The GEM study aims to investigate four potential blood biomarkers of stomach cancer. Stomach cancer is the fifth most common cancer worldwide and only one in five patients diagnosed will survive the disease for 5 years. Early stomach cancer is easily missed on endoscopy, so researchers are looking for other ways to diagnose the disease early.

Our study will test levels of different stomach hormones in blood samples from endoscopy patients to see if these hormones are associated with pre-cancerous changes in the stomach. If so, there may be potential in the future to develop a blood test to monitor a patient’s risk of developing stomach cancer.

Stomach Cancer and Pre-Cancerous Conditions

Stomach cancer takes a long time to develop and usually develops from ‘pre-cancerous’ lesions. Chronic inflammation, caused by the bacteria H. pylori, damages the stomach lining, resulting in these pre-cancerous lesions. In a small number of cases, this damage can continue, leading to stomach cancer. The damage to the stomach lining also affects the production of hormones in the stomach and it is this association that the GEM study will be investigating.

What type of study is the GEM study?

The GEM study is a case-control study. This means that we will compare the hormone levels in people with pre-cancerous stomach lesions to those with a normal stomach lining. This type of study design allows researchers to discover what factors may be associated with certain diseases, eg smoking and lung cancer.

What are the expected results of the study and what impact are they expected to have?

From our previous research, we expect that the levels of one or more of the hormones we are testing for will correlate with a pre-cancerous stomach condition and that each hormone level might contribute different information. If so, future work could then focus on developing a blood test for these hormones that could be used to detect pre-cancerous lesions and early-stage stomach cancer. Improved prevention and early diagnosis of stomach cancer is one of the best avenues to reducing deaths from this disease.

When and where does the study take place?

The study opened to recruitment in mid-2024 at participating hospital sites in Oxford.

Who is included in the study?

Around 600 patients undergoing endoscopy procedures who consent to take part in the study, 400 of whom are found to have a pre-cancerous stomach lesion on endoscopy. The study will also measure hormone levels in banked blood samples taken previously from patients who consented for their sample to be used in medical research.

What approvals has this study received?

The study has undergone review with the sponsor, Imperial College London. All research in the NHS is overseen by the Health Research Authority (HRA) and reviewed by an independent group, the NHS Research Ethics Committee to ensure protection of your safety, rights, well-being and dignity. The study has been reviewed and given a favourable opinion by an NHS Research Ethics Committee.

What type of information will we hold for the purposes of the GEM study?

The patient data we collect includes data from electronic health records such as endoscopy reports, pathology reports and relevant patient demographics such as co-morbidities, medical history and regular medications. We will also hold laboratory data such as the concentration of serum analytes.

How long will we retain the data?

Imperial College London, the organisation responsible for this study, requires us to hold data from all clinical studies for 10 years after the study end date. We therefore expect to hold this data until December 2035.