The Leeds Teaching Hospitals NHS Trust

Research study: A pan cancer programme of tumour typing

9 June 2021

Cancer affects approximately 1 in 2 people in the UK during their lifetime, and the outlook varies markedly across the multitude of the 200 or so cancers. Low survival rates can be attributable to many causes, such late diagnosis or poor response to surgery and/or chemotherapy. Regardless of the malignancy, achieving curative treatment in advanced disease is uncommon, such that there is a need to develop new, more effective treatments, particularly in instances where first line therapies have failed.

While universities and other research centres play a key role in improving our understanding of cancer biology, large pharmaceutical companies are responsible for the development of new anti-cancer drugs. One of the difficulties they face is access to cancer specimens with associated patient data (e.g. the type of cancer, the treatment patients received and whether this was successful) held by NHS hospitals.

The aim of this project at the University of Leeds/St James’s University Hospital is to provide these to support the development of new drugs as well as understanding the multiple mechanisms responsible for the development of cancer and its resistance to treatment. In parallel, we will also make use of recent advances in artificial intelligence that can aid pathologists with cancer diagnoses by using scanned, high-resolution images of the slides they would normally examine under the microscope, thus potentially increase the speed of diagnosis, as well as its accuracy.

This project is funded by TriStar Technology Group LLC, a commercial US-based contract research company that works with various health centres throughout Europe, including the NHS in the UK, to access cancer specimens. TriStar is a private company who are not a direct part of the NHS but rather an external collaborator. Nevertheless, they are bound by the strict data protection laws governed by the UK. TriStar works in partnership with pharmaceutical companies across the globe to support their development of new cancer tests and treatments. Although TriStar is covering the costs of NHS staff involved in cancer specimen and data collection, these samples will not be ‘used for financial gain’ or ‘sold to a third party’ by the NHS.

This project involves collecting excess tissue and scanning specimen slides of 12,000 historical cases of various cancer types (e.g. breast, skin, digestive system, liver, reproductive system, lung, brain and urinary system) and some non-cancer counterparts (for diagnostic comparison) held in the Leeds Teaching Hospitals histopathology archives. Cancer cases will be identified from clinical records by the Chief Investigator, and both samples and clinical (not personal) data will be transferred to TriStar. Accessing patient records is required to collect information about disease and response to treatment, but all data will be anonymised by removing patient identifiers such as name, address, date of birth and NHS number, replacing them with a unrelated study number before being sent to TriStar (i.e. it will be not be possible to identify patients from the data).Data will be digitally stored securely within the NHS systems and transferred to TriStar via a secure encrypted cloud server. Subsequent investigations on the specimens will vary depending on the pharmaceutical company’s drug development programme(s). Sample/data collection will have no impact on patient care, present or future. It will however make best use of historical cancer specimens, which would otherwise be kept for 30 years before being destroyed with no benefit to patients. Importantly, it will benefit future patients by supporting successful drug development.

There is also an academic research benefit to this project. Half of each of the cancer specimens processed by TriStar will be returned to Leeds (at TriStar’s expense). These will then be made available to scientists and doctors at the University of Leeds/Leeds Teaching Hospitals NHS Trust and boost cancer research, both at Leeds and internationally. These benefits will take the form of clinical material and data supporting postgraduate research programmes, collaborative studies on rare malignancies (the numbers of which would in any given centre otherwise be too small to support a viable project) and increased opportunities for securing research funding. This will be achieved whilst strengthening the existing collaborative research framework between the University of Leeds and Leeds Teaching Hospitals Trust, and contribute to making Leeds a centre of excellence for cancer research. Building this framework will enable our local research environment to support a wider scale of patient led projects with further invaluable input from the Patient and Public Involvement group at Leeds.

Patients will not be asked for permission to access their records since this project is based on old, historical cases. Many of these patients will unfortunately have passed away or moved home. However, we recognise that some patients will still be alive and may be unwilling to have their cancer material or data used for research.

Therefore, we invite anyone who would like to know more about this project or who would wish to ensure that their records are not accessed for research to contact us by 23 July 2021. This will enable us to keep a register of names to prevent these cases from being used. After the start of the project, it will still be possible for us to trace specimens before they are sent to TriStar, so we encourage anyone wishing to contact us by 3 September 2021. These cases can then be excluded from the study too.

The project has been approved by a Patient & Public Involvement Group, a Research Ethics Committee and the Health Research Authority at the recommendation of the Confidentiality Advisory Group, and is fully compliant with UK law.

For enquiries and further details, please contact the Chief Investigator:

Dr Nic Orsi

Clinician Scientist in Histopathology

Leeds Institute of Cancer & Pathology

Wellcome Trust Brenner Building

St James’s University Hospital

Beckett Street

Leeds LS9 7TF

Tel: 0113 3438625

Email: mednmo@leeds.ac.uk